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Characteristics and Methodological Quality of 25 Years of Research Investigating Psychosocial Interventions For Cancer Patients

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Cancer Treatment Reviews 35 (2009) 475–484

Contents lists available at ScienceDirect

Cancer Treatment Reviews


journal homepage: www.elsevierhealth.com/journals/ctrv

GENERAL AND SUPPORTIVE CARE

Characteristics and methodological quality of 25 years of research


investigating psychosocial interventions for cancer patients
Anne Moyer a,*, Stephanie J. Sohl b,d, Sarah K. Knapp-Oliver c,e, Stefan Schneider a,f
a
Stony Brook University, Department of Psychology, Stony Brook, NY 11794-2500, USA
b
Mount Sinai School of Medicine, Department of Oncological Sciences, 1425 Madison Avenue, Box 1130, New York, NY 10029-6574, USA
c
Department of Psychology, Mount Holyoke College, 50 College Street, South Hadley, MA 01075-1462, USA

a r t i c l e i n f o s u m m a r y

Article history: The considerable amount of research examining psychosocial interventions for cancer patients makes it
Received 4 December 2008 important to examine its scope and methodological quality. This comprehensive overview characterizes
Received in revised form 11 January 2009 the field with as few exclusions as possible. A systematic search strategy identified 673 reports compris-
Accepted 4 February 2009
ing 488 unique projects conducted over a 25 year time span. Although the literature on this topic has
grown over time, the research was predominantly conducted in the United States (57.0%), largely with
breast cancer patients (included in 70.5% of the studies). The intervention approach used most frequently
Keywords:
was cognitive behavioral (32.4%), the treatment goal was often improving quality of life generally (69.5%),
Cancer
Psychosocial
and the professionals delivering the interventions were typically nurses (29.1%) or psychologists (22.7%).
Intervention Overall, there was some discrepancy between the types of interventions studied and the types of support-
Treatment ive services available to and sought by cancer patients. Strengths of this research include using random-
Quality of life ized designs (62.9%), testing for baseline group equivalence (84.5%), and monitoring treatment, which
rose significantly from being used in 48.1–64.4% of projects over time. However, deficiencies in such
areas as examining treatment mechanisms and the adequacy of reporting of methodology, essential
for useful syntheses of research on these interventions, remain to be addressed. Methodological chal-
lenges related to the complexity of this applied research, such as participants seeking treatment outside
of research, contamination, and reactions to randomization, also were apparent. Future research could
benefit from closer interactions between academic and voluntary sectors and expanding the diversity
of participants.
Ó 2009 Elsevier Ltd. All rights reserved.

Introduction spiritual effects; and practical issues, such as employment,


finances, and insurance coverage.8 If cancer progresses despite
At most recent report, more than 11 million Americans were treatment, worries about the future predominate.9 Late-stage can-
living with cancer.1 Cancer’s diagnosis, treatment, and aftermath cer brings existential concerns10 and potentially pain.11 With the
present challenges that can contribute to psychological morbidity recognition of such difficulties, attention in recent decades has
and can compromise quality of life. Diagnosis involves many been directed at developing and testing interventions to improve
stressors and can provoke worries about functioning, social value, the quality of life of individuals coping with cancer.12
finances, burden on one’s family, and death.2,3 Cancer treatments Quality of life is subjective and multidimensional. Seven dimen-
produce side effects, such as fatigue, nausea, and changes in sions affected by cancer and its treatment are: (1) physical concerns,
appearance and functioning that can be difficult to cope with.4–7 (2) functional ability, (3) family well-being, (4) emotional well-
After treatment is complete, stressors involve continued medical being, (5) treatment satisfaction, (6) sexuality and intimacy, and
follow-up; residual physical, interpersonal psychological, and (7) social functioning.13 Accordingly, interventions aimed to im-
prove the quality of life for individuals diagnosed with cancer are di-
verse and often feature multiple potentially therapeutic
* Corresponding author. Tel.: +1 631 632 7811; fax: +1 631 632 7876. components targeted at multiple outcomes.2,14 Some types resem-
E-mail addresses: anne.moyer@sunysb.edu (A. Moyer), Stephanie.Sohl@mssm. ble common psychotherapeutic approaches, such as group cogni-
edu (S.J. Sohl), sknapp@mtholyoke.edu (S.K. Knapp-Oliver), Stefan.schneider@
tive behavioral therapy,15,16 problem-solving therapy,17 and
sunysb.edu (S. Schneider).
d
Tel.: +1 212 659 5504; fax: +1 212 849 2566.
psychodynamic psychotherapy.18 However, various other ap-
e
Tel.: +1 413 538 2107. proaches also have been tested. Some examples include: written
f
Tel.: +1 631 632 7875; fax: +1 631 632 7876. expressive disclosure,19 nurse-administered self-care self-efficacy

0305-7372/$ - see front matter Ó 2009 Elsevier Ltd. All rights reserved.
doi:10.1016/j.ctrv.2009.02.003
476 A. Moyer et al. / Cancer Treatment Reviews 35 (2009) 475–484

enhancement,20 complementary and alternative medicine sup- exclusions as possible. We therefore conducted a comprehensive
port,21 movement and dance,22 and audiotaped side effect manage- synthesis of 25 years of published reports and unpublished disser-
ment education.23 Similarly, the range of outcome variables tations evaluating psychosocial interventions designed to improve
assessed in studies evaluating such interventions (e.g. depression, the quality of life of cancer patients. We analyzed characteristics
anxiety, body image, pain, fatigue, fear of recurrence, levels of per- of the reports, the participants, the treatments investigated and
ceived social support, sexual functioning, marital satisfaction, sleep their delivery, the outcomes assessed, the methodological quality
disruption) reflects this multidimensionality in the conceptualiza- of these studies, and challenges noted by investigators conducting
tion of quality of life. this research. We also examined trends over time in the amount
Given the now considerable amount of research examining psy- of research being conducted and its methodological quality.
chosocial interventions for cancer,24 it is important to examine its
scope and quality. Such an evaluation can characterize this litera-
ture, analyze trends over time, and identify directions for improve- Method
ment. A comprehensive review also is useful in understanding
what types of individuals, with what types of cancers, exposed to Study identification
what types of psychosocial interventions have been subjected to
empirical scrutiny. This can identify understudied populations Studies included in the review examined psychosocial interven-
and determine to what extent available resources for cancer pa- tions for adult cancer patients that: (1) reported outcomes on psy-
tients have been evaluated. chological, emotional, behavioral, physiological, functional, or
Attention to methodological quality is also important. In prior medical status; (2) were first reported as a published article or
reviews, the quality of investigations studying psychological ther- an unpublished dissertation between January 1980 and December
apies for cancer patients was deemed suboptimal. In Newell et al.’s 2005; and (3) included 10 or more individuals per group. Studies
evaluation of 155 randomized, controlled trials of psychological examining interventions aimed at increasing adherence to anti-
therapies for adult and child cancer patients, the median quality cancer treatment and focusing exclusively on caregiver outcomes
score was less than one-third of the maximum number of points were outside the purview of this review. Electronic databases (Psy-
possible.25 The authors noted that this was likely related to poor cINFO, PubMed, and Dissertation Abstracts International) were
reporting of methods. In Rehse and Pukrop’s26 review of 37 pub- searched using key terms (e.g. cancer, neoplasms, tumor, and psy-
lished controlled studies investigating psychosocial interventions’ chosocial intervention, psychotherapy, psychological treatment,
effect on quality of life, studies scoring lower in methodological education, cognitive behavioral, relaxation, stress management,
quality had smaller outcome effect sizes. support group, self-help group, nursing intervention, biofeedback;
Studies of psychosocial interventions for cancer patients have a full list is available from the authors upon request). The reference
been criticized for narrow inclusion criteria and for being too lists of included reports and of 94 prior reviews and meta-analyses
intensive to allow participation of those most in need27 but such also were examined. Descendancy searches were conducted on
criticisms need to be empirically validated.28 Some investigators prior reviews (i.e. for subsequent articles citing them), and tables
have pointed out the dearth of non-European American samples of contents of several journals (Psycho-Oncology, Journal of Clini-
and the typical low statistical power of research in this area.29 cal Oncology, Cancer, Journal of Psychosocial Oncology, European
Other research has noted the high levels of dropout associated with Journal of Cancer, and Cancer Nursing) were searched.
psychosocial interventions for cancer patients.30,31 Such methodo- The sample included 673 reports comprising 488 projects, (a
logical shortcomings may bias estimates of treatment efficacy.26,32 QUORUM flowchart and a complete listing of the reports is avail-
Closer attention to methodology and its impact, such as on partic- able from the authors). Separate reports based on the same sample
ipation rates, would help direct future inquiry, intervention devel- (e.g. separate articles reporting outcomes at 3-month and 12-
opment, and approaches to improve methodology. month follow-up) were consolidated as a single project.
A number of high-quality reviews and meta-analyses have
investigated the efficacy of psychosocial interventions for cancer Study coding
patients. For example, Meyer and Mark33 conducted a meta-analy-
sis of 45 randomized, controlled studies of psychosocial interven- Coding by the PI and two teams of thoroughly-trained graduate-
tions with adult cancer patients published between 1979 and level coders was guided by a detailed manual. Information from all
1993; Devine and Westlake34 reviewed 116 studies reported be- project reports was used to provide comprehensive ratings. Coders
tween 1976 and 1993 examining psycho-educational care for can- met regularly to prevent coding drift, discuss coding dilemmas,
cer patients; Newell and colleagues 25 reviewed randomized, and to reach consensus on independently-coded projects used for
controlled trials published between 1980 and 1998 evaluating reliability estimation (which represented 9.2% of the total sample).
the effectiveness of a psychosocial interventions aimed at improv- Ten key continuous a priori coding items were examined for reli-
ing cancer patients’ psychosocial, side effect, immune, or survival ability. The average two-way mixed effect intraclass correlation44
outcomes. In addition to reviews selecting studies with particular assessing the agreement for the ratings of the PI, Coders 1, and 2
types of designs or levels of quality, more focused reviews have was .83 and for the ratings of the PI, Coders 3, 4, and 5 was .90.
concentrated on patients with particular types of cancer, such as Ten key categorical a priori coding items were also examined.
breast,35or stages of cancer, such as advanced,36 particular out- The average generalized kappa45 assessing the agreement for the
comes, such as fatigue,37 depression and anxiety,38,39 or sur- ratings of the PI, Coders 1, and 2 was .72 and for the ratings of
vival,40,41 or particular types of interventions, such as physical the PI, Coders 3, 4, and 5 was .61.
activity,42 or guided imagery.43 Items assessing the nature of the research involved characteris-
Previous reviews and meta-analyses predominantly have fo- tics of the principal investigator, the project’s funding and publica-
cused on evaluating the extent to which evidence supports inter- tion status, location of data collection, aspects of the project’s target
ventions’ efficacy. Methodological and reporting limitations often sample, and the characteristics of those who participated. Interven-
have led to studies being excluded from these reviews.25 By con- tion characteristics, such as its approach, ingredients, delivery,
trast, rather than summarizing outcomes, the purpose of the pres- duration, and the outcomes measured, were also assessed.
ent review was to characterize the evolving nature and scope of Items assessing the quality of study methodology and reporting
psychosocial cancer intervention research as a whole, with as few involved aspects of the sample description; the research design,
A. Moyer et al. / Cancer Treatment Reviews 35 (2009) 475–484 477

including the quality of randomization, where applicable; inter- Table 1


vention specification and provision; and data analyses, such as Participant characteristics.

whether intention-to-treat analyses were conducted. These were Characteristic Mean SD n


adapted from a set of methodological quality items used in prior Demographic characteristics
work.46 Although consensus on essential areas of methodological Age (years) 54.1 7.2 443
quality has yet to be reached, and no one scale is considered appro- Female (%) 71.1 29.6 452
priate for all research topic areas,47 we included aspects of quality White (%) 81.2 23.3 173
Years of education 13.7 3.1 75
conventionally considered important. Due to the low feasibility of College attenders (%) 54.2 22.8 149
keeping participants and interventionists blind to treatment Employed (%) 52.2 21.5 138
groups for psychosocial interventions, items assessing this were Married (%) 71.1 12.3 271
not included. Similarly, because outcomes in this area are predom- Income (in $1000) 48.5 20.3 10
Low income (%) 53.4 37.6 4
inantly based on self-report, assessments of blinding of outcome
assessors also were not included. Aspects of reporting from the Disease and treatment characteristics
Stage 0 (%) 1.3 4.1 139
CONSORT,48 such as noting the number dropping out of treatment,
Stage I (%) 34.4 27.0 124
also were evaluated. Because combining different dimensions of Stage II (%) 36.4 24.4 121
methodological quality is not advised,49 we report them Stage III (%) 11.8 19.0 137
separately. Stage IV (%) 11.4 25.0 146
Items assessing challenges in conducting this research had to do Treated with surgery (%) 84.2 30.4 210
Treated with radiation (%) 52.3 34.3 197
with possible biases introduced during recruitment, retention, and
Treated with chemotherapy (%) 63.0 33.9 222
randomization, and unintended consequences, such as participants Time since diagnosis (months) 18.1 18.5 113
seeking treatment outside of the research study and contamination
across intervention conditions.
Goals
Interventions were primarily directed at improving quality of
Results life generally, but also at coping with treatment side effects and
the physical effects of the disease. A relatively small proportion
Study, investigator, report, and sample characteristics of interventions was developed to increase understanding of treat-
ment options or exclusively to improve social relationships. Other
There was a dramatic increase in the number of studies con- stated treatment goals included improving memory or concentra-
ducted over the 25 year period, from an average of 10 projects tion, increasing compliance with medications, and altering tumor
per year appearing in the 1980s, to 22 per year from 1995 to progression or length of survival.
1999, to 36 per year from 2000 to 2005. The majority of principal
investigators was affiliated with a university (75.3%), held a Ph.D. Target patient populations
(66.8%), and was female (59.85). The projects most often were Although a minority of projects designed an intervention for
funded by private foundations (40.4%) and federal agencies any type of cancer patient, others focused on specific types, such
(34.3%), but a fairly high proportion (36.3%) did not report any as those undergoing a particular type of treatment (e.g. chemother-
funding support. The majority of studies was conducted in North apy), or with a particular type of cancer. Particular cultural groups
America and the UK (74.5%) and written in English (98.4%), but targeted in a small proportion of projects included African-Ameri-
the remainder was conducted in an additional 16 countries. A large can and Hispanic-American, Japanese, Chinese, Taiwanese, and
proportion of the projects (87.1%) comprised at least one published Indonesian patients. Only a small number targeted adults of partic-
report, but 65 out of 107 projects included dissertations that were ular age groups (e.g. younger or elderly) or designed interventions
unpublished as of November, 2008. The cancer types included in specifically for cancer patients of a particular gender (beyond spec-
the samples (assessed at the study level) were often breast ifying patients with gender-specific cancers, e.g. prostate).
(70.5%), lung (28.9%), colon/colorectal (20.9%), and prostate
(18.4%). Patients in the samples were most often undergoing treat- Theoretical approach
ment (38.9%) or post treatment (13.5%) at the time they were re- In almost one-third of the projects, the active treatment(s) in-
cruited to participate. volved a primarily cognitive, behavioral, or cognitive behavioral
approach (i.e. types of psychotherapy that focus on recognizing
Participant characteristics and altering problematic thoughts and behaviors and reducing
negative emotions38). For example, one study included programs
The total number of participants studied in this group of pro- that involved: developing effective problem-solving skills and
jects was 46,665. identifying and challenging maladaptive thoughts; learning relax-
Participant characteristics are displayed in Table 1. Although ation techniques; and utilizing resources such as family and friends
demographic characteristics were not always reported (e.g. age and pleasurable activities to cope.50,51
was reported for 90.8% of the projects, but marital and employ- Approximately one-fifth of projects examined interventions
ment status only for 55.5% and 28.3%, respectively), the typical that were primarily educational or informational (i.e. increasing
participant was female, in her mid-50’s, White, married, and knowledge and reducing uncertainty by providing information
well-educated. Disease and treatment characteristics were through print, audiovisual, or interpersonal channels).38 Examples
reported in less than half of the projects, but when they were, pa- include an oncology clinic orientation52 and information about
tients tended to have early-stage cancer and to be approximately treatment options,53 side effects,54 or psychosocial challenges.55
18-months post-diagnosis. Close to one-fifth of investigations primarily involved complemen-
tary and alternative medicine (CAM; i.e. medical and health care
Intervention characteristics systems, practices, and products not considered part of conven-
tional medicine practiced by allied health professionals56); or
Characteristics of the interventions investigated are presented mind–body approaches. Examples included exercise,57,58 mas-
in Table 2. sage,59 acupuncture,60 and meditation and yoga.61
478 A. Moyer et al. / Cancer Treatment Reviews 35 (2009) 475–484

Table 2 existential,63 Rogerian,64 and supportive/expressive.65 A small pro-


Intervention characteristics and outcomes assessed. portion involved social support provided by non-professionals,
n % typically fellow cancer survivors, such as a non-moderated e-mail
Goal of intervention support group,66 online bulletin boards,67 and telephone support.68
Improved quality of life 339 69.5 Approximately one-fifth included a multimodal intervention that
Improved coping with treatment side effects and relief from physical 106 21.7 incorporated multiple therapeutic approaches. For instance, the
effects of disease multidimensional cancer rehabilitation program involved informa-
Increased understand of treatment options and improved satisfaction 24 4.9
with treatment decisions
tion, exercise, sports, expressing negative emotions, support and
Improved social relationships 1 .2 validation, breathing, relaxation, and stress management.69 Other
Other treatment goal 18 3.7 approaches not part of these categories, involved, for example,
Target patient populations the American Cancer Society’s Look Good. . .Feel Better program
Particular gendera 6 1.2 that uses professional cosmetologists to improve appearance70
Particular type of cancera 225 46.0 and exposure to a restorative natural environment.71
Particular agea 8 1.6
Particular stage or type of treatmenta 301 61.7
Particular cultural or language groupa 10 2.0 Ingredients
Other targeta 74 15.2 More than half of the interventions included therapeutic ingre-
No particular target 58 11.9 dients that involved stress and symptom management (i.e. relaxa-
Type, theoretical orientation, or approach tion training, guided imagery), and about half included education
Cognitive, behavioral, or cognitive behavioral therapya 158 32.4 or information. Less than one-fifth each included physically-fo-
Education/informationa 100 20.5 cused activities (i.e. exercise, stretching, nutritional counseling);
Non-behavioral counseling or psychotherapya 52 10.7
Social Support (by non-professionals)a 28 5.7
psychotherapy; or expressive activities (i.e. writing, art, dance).
Complementary or alternative mind–body approachesa 90 18.4 Only a small proportion used spiritually-oriented activities (i.e.
Multimodal interventiona 95 19.5 prayer and discussing spiritual concepts). Other ingredients in-
Othera 21 4.3 cluded an audiotaped or written summary of the treatment consul-
Waiting list, control group, or treatment as usuala 323 66.2
tation, a question prompt sheet for medical appointments, games
Intervention ingredients (for distraction during chemotherapy), or access to a botanical
Developing coping skillsa 176 36.1
garden.
Education/informationa 235 48.2
Expressive activitiesa 61 12.5 The majority of studies with multiple intervention conditions
Physically focused activitiesa 84 17.2 included control conditions with little active care (no-treatment
Psychotherapya 73 15.0 control, treatment as usual—which typically did not include psy-
Stress/symptom managementa 241 49.4 chosocial care–, or wait-list). For the active treatment conditions
Social supporta 168 34.4
(i.e. not control or usual care) for which the length of treatment
Spirituala 8 1.6
Othera 76 15.6 could be determined, the average number of planned sessions
Standard carea 93 19.1 was 11.87 (SD = 32.48), the average number of scheduled hours
Mode of Delivery was 10.63 (SD = 17.77; including self-administration at home if
Individuala 279 57.2 this was an explicit part of the intervention), and the average span
Groupa 167 34.2 of time over which interventions took place was 9.27 weeks
Telephonea 61 12.5
(SD = 14.32). More than half of the projects included interventions
Interactive computer/internet/videoa 17 3.5
Non-interactive audiotapes/videoa 158 32.4 with components that were delivered to patients individually
Written materialsa 187 38.3 (occasionally including a spouse, family member, or caregiver also)
Self-administered/directeda 206 42.2 and about one-third had components that were delivered to
Othera 17 3.5 groups of patients. A small proportion of projects used the tele-
Not applicable (control conditions)a 250 51.2
phone to facilitate this delivery. Approximately one-third of pro-
Not indicateda 11 2.3
jects each made use of written materials or non-interactive
Individual conducting the intervention
audiotapes or videotapes, but a smaller proportion used interactive
Nursea 142 29.1
Physiciana 38 7.8 computers or videos or the internet. Fewer than half of projects
Psychologista 111 22.7 examined treatments that featured self-administered components.
Psychiatrista 18 3.7
Social workera 41 8.4
Individual conducting the intervention
Peera 28 5.7
Othera 206 42.2 Professionals delivering the interventions were predominantly
Not applicable (control conditions)a 303 62.1 nurses or psychologists, whereas fewer were social workers, physi-
Outcomes assessed 79 16.2 cians, or psychiatrists. A minority of interventions was led by
Mental health/psychological or emotional functioninga 404 83.8 peers. Others included dieticians, physical therapists, occupational
Cognitive/occupational functioninga 79 16.2
therapists, massage therapists, hypnotherapists, Reiki and Tai Chi
Relationship/social/sexual/family functioninga 154 31.6
Improvement of the cancer treatment processa 121 24.8 masters, reflexologists, acupuncturists, counselors, yoga teachers,
Physical symptomsa 288 59.0 dance teachers, music therapists, exercise physiologists, chaplains,
Quality of lifea 141 28.9 trained facilitators, family members, caregivers, or significant
Survival/immune/physiologic/medical measuresa 137 28.1
others.
Other outcomes 166 34.0
a
Categories not mutually exclusive. Outcomes assessed
The mean number of different outcomes reported per project
was 13.10 (SD = 10.58). In keeping with the goals of maintaining
Approximately one-tenth of projects included interventions or improving quality of life, mental health or psychological or emo-
that involved non-behavioral counseling or psychotherapy (i.e. tional functioning outcomes were assessed in a majority of the pro-
psychosocial care provided by a qualified professional).38 Examples jects. Physical symptoms also were assessed in a majority of
of types of psychotherapy included interpersonal,62 experiental- projects. General quality of life measures (e.g. the Functional
A. Moyer et al. / Cancer Treatment Reviews 35 (2009) 475–484 479

Assessment of Cancer Therapy Scale; FACT)72 were used to assess level, marital status, employment status, and disease- and treat-
outcomes in almost one-third of the projects, as were relation- ment-related variables, such as stage of cancer and type of treat-
ship/social/sexual/family functioning, improvement in the cancer ment. Occasionally, psychological variables, such as mood
treatment process, and survival/physiologic/medical measures. disturbance, also were included.
Cognitive/occupational functioning was assessed in a smaller pro-
portion of projects. Other outcomes, such as satisfaction with the Research design
intervention, were assessed in approximately one-third of the The majority of projects used randomized experimental de-
projects. signs, whereas a minority used non-randomized comparisons,
and single-group designs. More than half of the randomized de-
Quality of study methodology and reporting signs only stated their design to be randomized whereas fewer de-
scribed their procedure and included methods to prevent
The results of items assessing the quality of study methodology subterfuge (i.e. concealing the allocation schedule from those mak-
and reporting are displayed in Table 3. We compared the method- ing group assignments).
ological quality of older versus more recent research in the dataset
by dividing the sample of projects in half and contrasting the 241 Intervention provision and specification
projects first reported during 1980–1998 with the 247 projects Where applicable (i.e. the intervention was delivered by a per-
first reported during 1999–2005. son), fewer than one-third of projects mentioned using manuals to
standardize delivery. More than half, however, assessed interven-
Sample description tion implementation by monitoring the integrity of treatment
Overall, whereas most projects reported the initial number of (e.g. noting the number of sessions attended, audiotaping and
participants in their sample, fewer than half reported the number reviewing sessions, or having participants log their practice). A
approached to participate and fewer than half reported the number minority assessed implementation by measuring the immediate
of dropping out of the intervention. Few provided information on effects of treatment on intermediate variables through which
the representativeness of their sample by comparing the character- interventions were believed to affect outcomes. For instance, in a
istics of participants to non-participants. These comparisons typi- study investigating the effects of cognitive behavioral stress man-
cally involved demographic variables, such as age, education agement training on the quality of life of prostate cancer patients,

Table 3
Quality of study methodology and reporting.

1980–1998 1999–2005 All


n % n % n %
Sample description
Reported number approached to participate 88 36.5 112 45.3 200 41.0
Reported number initially participating* 210 87.1 232 93.9 442 90.2
Compared characteristics of participants to eligible non- participants 17 7.1 19 7.7 36 7.4
Reported number dropping out of treatment 101 41.9 116 47.0 217 44.5
Research design
One group post test only 10 4.1 7 2.8 17 3.5
One group pre and post test 36 14.9 58 23.5 94 19.3
Nonequivalent control group without matching or statistical control 26 10.8 13 5.3 39 8.0
Nonequivalent control group with matching or statistical control 9 3.7 4 1.6 13 2.7
Randomized experiment 150 62.2 157 63.6 307 62.9
Other design/design not indicated 10 4.1 8 3.2 18 3.7
Quality of randomization, for randomized experiments (n = 307)*,b
Randomization implied but not stated 2 1.3 1 0.6 3 1.0
Method only stated to be randomized 88 58.7 81 51.6 169 55.0
Randomization procedure described but no measures to prevent subterfuge included 42 28.0 37 23.6 79 25.7
Randomization procedure described and measures to prevent subterfuge included 18 12.0 38 24.2 56 18.2
Intervention provision and specification
Manuals used to guide treatment (where applicable, n = 607 intervention conditions) 87 27.3 93 32.5 182 30.0
Intervention implementation assessed
Intervention monitoreda,*** 116 48.1 159 64.4 275 56.4
Assessed immediate effects of interventiona 26 10.8 28 11.3 54 11.1
Additional intervention monitored 37 15.3 41 16.6 78 16.0
Contamination monitored (where applicable, n = 368) 20 8.2 25 10.1 45 12.2
Process analyses conducted
Linked intervention elements or duration to outcomea 38 15.7 37 15.0 75 15.4
Examined mediating factorsa 29 12.0 25 10.1 54 11.1
Data analyses
Groups compared for equivalence at baseline (where applicable, n = 375)** 155 79.0 163 90.5 317 84.5
Interaction between treatment condition and dropout status (re: study treatment 4 1.1 9 2.4 13 3.6
or follow-up on pretreatment variables examined, where applicable n = 365)
Intent-to-treat analyses conducted** 21 8.7 44 17.8 65 13.3
a
Categories not mutually exclusive.
b
df = 3.
*
p < .05.
**
p < .01.
***
p < .001.
480 A. Moyer et al. / Cancer Treatment Reviews 35 (2009) 475–484

the investigators assessed the extent to perceived stress manage- exclusions that involved having a psychiatric history, taking psy-
ment skills had improved.16 Process analysis, which examines the choactive drugs, or having clinically significant distress.
means by which interventions are intended have their effect, either
by linking intervention elements or duration to outcome or exam- Exclusion and dropout rates
ining mediating mechanisms (e.g. examining whether patients in For only approximately 15% of the projects (n = 72) was it pos-
education intervention groups acquired more information than sible to determine the proportion of potential participants who
peer discussion intervention groups),73 was not often pursued. were excluded by such criteria, which was 34.3%, (SD = 28.3%;
range 0–96.0%). For approximately one-third of the projects
Data analyses (n = 178) it was possible to calculate the mean proportion of eligi-
A majority of applicable multiple-group projects reported that ble participants not involved in the study, which was 27.4%
intervention groups were compared at baseline for equivalence (SD = 20.9%; range: 0–88.0%). Being involved entailed, at mini-
on select variables, but far fewer investigated if there was differen- mum, agreeing to participate and/or being enrolled and/or being
tial dropout of participants with certain characteristics from com- assigned to an intervention group and/or completing baseline
pared groups. Intent-to-treat analyses were performed in relatively assessments and/or beginning treatment. For fewer than half of
few projects. The average number of participants per group in- the projects (n = 215) was it possible to calculate the mean propor-
cluded in the first follow-up point was 47.20 (SD = 65.14, tion of participants dropping out of intervention, which was 11.3%
n = 406), translating to an average power to detect a medium effect (SD = 11.8%; range = 0–55.0%).
size of .78.
Sample representativeness
As was mentioned earlier, only a small proportion of studies
Changes over time (n = 36) provided information on the representativeness of their
There was a significant increase over time in the proportion of sample by comparing the characteristics of participants to non-
projects that reported the initial number of participants in the participants. These comparisons typically involved demographic
sample. For randomized designs there was a significant improve- variables, such as age (n = 23), education level (n = 8), marital sta-
ment in the quality of the randomization v2(3) = 7.93, p < .05, with tus (n = 14), employment status (n = 4), and disease- and treat-
the proportions of projects including measures to prevent subter- ment-related variables, such as stage of cancer (n = 13) and type
fuge rising significantly from 12.0% to 24.2%, v2(1) = 7.66, p < .05. of treatment (n = 10). Only occasionally were psychological vari-
The only aspect of intervention provision that improved signifi- ables, such as mood, anxiety, or coping style, included (n = 8). Ta-
cantly over time was intervention monitoring. There were also sig- ken together, these analyses provided an incomplete picture of
nificant increases in the proportion of studies that examined group the differences between participants and non-participants.
equivalence at baseline and used intent-to-treat analyses. Although the majority of studies did not find an effect for age, in
the ones that did, there was a tendency for participants to be youn-
Exclusion rates and study and intervention participation rates ger than non-participants. Studies also tended to find that partici-
pants indicated more distress than non-participants. In a few
Recruitment strategy studies the reasons for refusing mentioned by non-participants
About a quarter of studies (23.8%) used the rigorous method of were noted; they typically involved conflicting demands and lack
recruiting potential participants from consecutive patients, where- of interest. For instance, a study of an intervention to enhance
by all patients at a treatment center were screened or invited to communication between patients about to undergo radical prosta-
participate. The most common source, however, was non-consecu- tectomy and their medical providers and partners, of 101 non-par-
tive patients (42.6%). Approximately a quarter of studies (25.2%) ticipants, 47% noted they were too busy and 14% were not
used referral or invitation by a medical care provider and 10.2% interested; 12% also found the questionnaire too personal.74
used advertisements. Other recruitment sources, such as tumor Similarly, only a small proportion of studies (n = 13) reported
registries, lists of enrollees in other trials, support agencies, whether there was differential dropout of participants with partic-
churches, and attendees of presentations in the community, were ular characteristics from intervention and comparison groups.
used in 16.4% of the projects. Overall, few significant interactions between intervention group
and baseline characteristics in predicting dropout were noted, per-
Eligibility criteria haps due to low power.
The vast majority (96.9%) of studies specified inclusion and
exclusion criteria. Although the rationale for these criteria often Unintended events: additional treatment and contamination
was not explicitly stated, reports typically used criteria related to We also examined unintended events, whereby participants re-
the target population that the intervention was designed for (i.e. ceived additional assistance related to quality of life that was not
their type of cancer, type of treatment, particular symptoms) and planned by the research team, or contamination, whereby partici-
sometimes medical or ethical contraindications for being involved pants (in multiple-group studies only) were exposed to elements
in the intervention (i.e. inability to participate in physical activity that made another intervention condition distinctive. These phe-
for exercise interventions, lack of permission from one’s physician, nomena are relevant to validity and may also provide insight into
lack of awareness of one’s diagnosis). Only 57 projects (11.6%) participants’ reactions to research participation. Although projects
specified as an inclusion criterion that participants have evidence did not often monitor or document additional assistance, 67
that an intervention would be indicated, such as pain, nausea, (13.7%) noted that it was received. Examples included support
insomnia, or elevated levels of distress. Many exclusion criteria groups provided outside of the study, professional counseling or
were logistical in that they specified, for example, living within a psychotherapy, antidepressant and anti-anxiety medications, vita-
reasonable distance from the study site. Because many interven- mins, body work, yoga, exercise, meditation, and prayer.
tions involved education, developing skills, or some level of mental Twenty-seven projects, or 7.3% of multiple-group studies, noted
participation, exclusion based upon not being of sound mind (e.g. that there was some unintended contamination of interventions
having cognitive impairment) was fairly common. Other exclusion across groups, whereby (typically control) participants tried to
criteria related to controlling extraneous or nuisance variables (e.g. gain access to therapeutic activities available to those in other trial
not participating in other studies, no prior cancer). There were also arms, aside from usual care. Examples included control group par-
A. Moyer et al. / Cancer Treatment Reviews 35 (2009) 475–484 481

ticipants joining an outside support group in a trial of two types of between the conditions under which the rest of the world’s popu-
group psychosocial support; control group participants keeping lation lives, has led to calls to expand the scope of the field of psy-
track of side effects, when monitoring side effects was part of the chology in general.79 These calls are relevant to psychosocial
experimental intervention; and a control participant obtaining a oncology research, also. Encouraging initiatives to address health
commercially-produced guided imagery tape in a study testing a disparities in cancer in terms of income, ethnic minority status,
version of such tapes. and health insurance coverage within the United States are now
underway.80
Although there is a great deal of support from federal govern-
Discussion mental agencies (both American and non-American) for research
on psychosocial interventions for cancer, a good portion of this
This overview reveals the topography of the field of psychoso- work is supported by private foundations. This speaks to public
cial intervention studies for adult cancer patients conducted over enthusiasm for this work, but it may also contribute to research
two-and-a-half decades. Research in this area increased dramati- being focused on cancers for which there is the most public advo-
cally, reflecting enthusiasm and support for providing empiri- cacy. For instance, although lung cancer samples made up the sec-
cally-based assistance and tools for individuals coping with ond-largest proportion after breast cancer samples in our dataset,
cancer’s diagnosis, treatment, and survivorship. This conclusion their representation in this research literature was by far less,
concurs with that of a recent Institute of Medicine (IOM) Report and out of proportion to the rates at which breast versus lung can-
which asserted there is a ‘‘wealth” of psychosocial resources (i.e. cer affects the population.81
information on cancer-related treatments, peer support, counsel- As indicated by the 107 projects that involved at least one doc-
ing/psychotherapy, medical supplies, transportation, family and toral dissertation, this is a fruitful area for budding investigators.
caregiver support, assistance with activities of daily living, legal More than half however, remained unpublished, prompting the
services, financial and insurance advice, benefits counseling, and question of whether these were of lower quality, had findings that
financial assistance) currently available to cancer patients.12 were null or unpalatable, or if their authors simply had other pri-
The IOM report also documented the great extent to which orities. Although a full exploration of their foci, methodological
these resources are provided by non-profit cancer support organi- quality, and results is beyond the scope of this review, the projects
zations in the voluntary sector. Although the 25 years of research consisting of unpublished dissertations were significantly less
summarized here involved more than 46,000 cancer patients (not likely to use randomized designs (61.5% versus 83.3%, v2 = 5.78,
all of whom were in active treatment conditions), just a single p < .05), suggesting that at least on some indices, they were less
non-profit organization among the dozens that exist, Cancer Care, rigorous.
provided free counseling, education, support groups, referral, and
financial assistance to 42,680 patients in 2005 alone.12 Thus, Intervention characteristics
although there were a few exceptions whereby evaluations of ser-
vices provided widely by non-profit organizations have been pre- Interventions often used cognitive behavioral approaches,
sented in the scientific literature (i.e. The American Cancer involving developing coping skills and stress and symptom man-
Society’s Look Good. . .Feel Better70 and Reach to Recovery pro- agement, and educational approaches, in line with the notion that
grams75,76 and the Wellness Community),77 the majority of re- cancer patients’ distress likely stems from coping with the many
search focusing on university-based-investigator-designed practical and tangible difficulties that cancer diagnosis, treatment,
interventions stands in contrast to the services available to, and end-of-life, and survivorship entail. Interventions focused on infor-
being used by, cancer patients. A discrepancy between the types mation about illness and treatment are preferred by patients.82 Of
of interventions evaluated by researchers and those most com- interest was the number of projects subjecting CAM or mind body
monly-used in actual practice, has been documented in other approaches to empirical scrutiny. The National Center for Comple-
areas, such as treatment for alcohol use disorders.78 This means mentary and Alternative Medicine at the National Institutes of
that clinicians seeking information on evidence-based interven- Health, established in 1998, has increased support for this type
tions have this available for only a subset of existing treatments. of research. This growing interest was reflected in significant in-
Closer interactions between academic and voluntary sectors could crease in the percentage of projects studying CAM approaches from
provide new insights for both. These might involve including evi- 12.4% to 24.3%, v2 = 11.38, p < .01. Cancer patients avail themselves
dence-supported elements in the services provided by non-profit of such treatments,83,84 often without their doctors’ recommenda-
organizations and rigorously evaluating interventions widely used tion, at higher rates than those without cancer, making testing
by non-profit cancer support organizations.8 Further inquiry into their efficacy important. Spiritual approaches, not represented
potential reasons for this discrepancy, such as whether the time prominently in the interventions tested here, also are commonly
and resources required discourage their widespread implementa- sought out by patients.85
tion is also warranted. Interventions were frequently designed specifically for patients
with a particular type of cancer or type of cancer treatment. How-
Investigator, report, and sample characteristics ever, inclusion criteria did not often specify that eligible partici-
pants be experiencing a particular difficulty or meet a particular
Although this overview was able to capture research conducted screening criterion. This may be based on the seemingly reasonable
in a number of countries, this work has predominantly been con- assumption that side effects associated with particular treatments
ducted in the United States and in samples of breast, lung, or pros- are common, and that being diagnosed with or treated for cancer
tate cancer patients who are White and well-educated. Just as prompts informational or psychosocial needs. For interventions
patients with different types of cancer may require different types addressing particular types of outcomes, such as depression and
of psychosocial interventions, differences in the types of treat- anxiety, screening for those at risk may produce stronger results.39
ments available, the meaning of cancer, and cultural mores about However, there also may be benefits for those who are not cur-
disclosure of disease may create differences in the types of inter- rently experiencing particular difficulties in preventing or mini-
ventions needed worldwide and their efficacy. Recognition that mizing future problems.86
the great majority psychological inquiry has been dominated by Fewer than 5% of interventions included patients that were in
US samples, investigators, editors, and journals, and the disconnect the palliation stage of treatment. The intervention approaches used
482 A. Moyer et al. / Cancer Treatment Reviews 35 (2009) 475–484

typically were not specific to palliative care (e.g. massage, acu- minorities, as well as patients with low-incomes and with more
puncture, aromatherapy, hypnosis, relaxation training) save for severe problems.93 Further research would need to examine the
one dissertation investigation that involved a family hospice inter- participant characteristics associated with commonly-used exclu-
vention (involving physical care with pain and symptom control, sion criteria to determine if this might also be the case for psycho-
crisis intervention, respite care, 24 h on-call coverage, education social oncology. Finally, because it was not examined in a large
and anticipatory guidance on home care, grief, time of death, proportion of projects, and not extensively examined in those
funerals, and legal matters, counseling, and follow-up bereave- for which it was studied, the differences between participants
ment care).87 Although engaging dying populations in research and non-participants in this research base remain poorly under-
may be challenging, the lack of investigation on this type of com- stood. This, however, may pose few difficulties in terms of the
prehensive end-of-life care represents an important gap in the external validity of this work, as in practice only interested and
literature. able patients will take part in such interventions.2 Exploring inno-
Quite an array of outcome variables was considered, in line vative modes of intervention delivery, such as via the internet,94,95
with the multidimensional conceptualization of quality of life. videoconferencing,96 or with workbooks97 for those without ac-
Survival/physiologic/medical outcome variables also were con- cess to computers, may increase the accessibility to those who
sidered in almost a third of projects, reflecting an expanding have less flexible schedules or the inability to travel to treatment
emphasis on biobehavioral measures.88 Although disruptions centers.
in work during and after treatment often are noted by cancer Reflecting the low overall rates of cancer patients in clinical re-
patients,12 cognitive or occupational outcomes were not often search, and the especially low rates for minorities, new funding ini-
assessed. The effects on work and finances largely have been tiatives are directed at improving enrollment rates in trials.98 A
neglected in this literature. Participant satisfaction was consid- new framework for accrual to clinical trials that takes into account
ered in 18.6% of projects, supporting the notion that investi- community, system, provider, and patient factors is beginning to
gators are interested in receiving feedback on the be applied and tested. For instance, one effort involved educating
acceptability of their interventions to cancer patients. Other the public about the importance of clinical trials, establishing trust
reviews have noted high levels of satisfaction with cancer through a radio show and sponsoring community events, providing
support groups.89 valet parking, educating hospital staff and providers about the
project, and giving attention to productive communication
Quality of study methodology and reporting strategies.99

Strengths of this literature as a whole include using predomi- Unintended events: contamination and additional treatment
nantly randomized designs, testing for group equivalence, and
monitoring treatment. However, deficiencies in other areas, such Because so few projects reported on participants obtaining
as examining treatment mechanisms and the adequacy of report- additional unplanned assistance and contamination across inter-
ing of methodology, essential for useful syntheses of this area, re- vention groups, it is difficult to estimate their prevalence, but even
main to be addressed. Aspects of methodological quality that the low overall rates give cause for some concern that balancing
improved over time were: specifying the number of participants the goals of research and participants is complex. Assessing unin-
at baseline, including measures to prevent subterfuge of the alloca- tended contamination and factoring it into analyses is one solution.
tion process in randomized designs, monitoring the integrity of While coding the projects summarized here, numerous difficulties
intervention delivery, examining group equivalence at baseline, were noted. These often had to do with participant preferences for
and using intent-to-treat analyses. one of the contrasted intervention groups over another. For in-
A small minority of studies conducted process analyses that stance, in a study of a CAM-oriented intervention for breast cancer
considered the mechanisms by which an intervention might have patients ‘‘many. . .responded to the advertisements because of an
its effects, either by linking the dose of treatment received to out- interest in CAM therapies, and did not want to be in the standard
comes or examining purported mediating pathways between group”.100, p. 63 In a randomized trial of psychosocial support for
interventions and outcomes. For example, an investigation testing patients with breast cancer ‘‘off-study support groups became an
a multimodal psychosocial group intervention for breast cancer pa- increasing problem,. . .as recognition of the potential benefits of
tients showed that, after adjusting for age, type of surgery, receipt support groups grew. . ., patients became unwilling to accept ran-
of chemotherapy or not, time since surgery, and baseline distress, domization”.101, p. 53 Difficulties such as these highlight the utility
changes in satisfaction with information received predicted fol- of examining the perspectives of potential recipients of psychoso-
low-up levels of distress.90 In an investigation of group psychother- cial interventions for cancer patients. For instance, in contrast to
apy, although the number of sessions attended was not related the few documented interventions that included spiritual elements
reductions in total mood disturbance,91 the extent of expressing and the majority that had closed group membership, patients
existential themes was.92 Such inquiry is recommended as a prior- themselves indicate interest in having spiritual concerns addressed
ity for future research.2 and drop-in formats.82
The findings of this overview must be viewed in light of poten-
Exclusion rates and study and intervention participation rates tial limitations such as the possibility that there were reports that
were not included because of the reliance on only three biblio-
Given that fewer than one-quarter of projects selected their graphic databases, difficulty locating particular reports, and
participants from the full population of patients at a particular language limitations. A final limitation is that, although the over-
treatment center (consecutive patients), and that the majority of view captures research conducted over a wide time span, newer
projects relied on other methods, it is likely that there is some interventions have not been captured, limiting the extent that
selection bias in the recruitment of participants. On their face, the trends documented apply to the literature published more
the exclusion criteria used in this literature seemed reasonable recently. Novel techniques, such as meaning-making interven-
from scientific and logistical points of view. However, in other tions102 and intimacy-enhancing interventions,103 and approaches
areas of research, commonly-used exclusion criteria, when applied such as a dignity-conserving emphasis in palliative care104 and
hypothetically to real-world samples of treated patients, have counseling interventions that focus on the family105 represent
been demonstrated to indirectly lead to under-representation of promising new directions.
A. Moyer et al. / Cancer Treatment Reviews 35 (2009) 475–484 483

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