Hannah June Matthews (Corresponding Author) - Matthe94@uni - Coventry.ac - Uk
Hannah June Matthews (Corresponding Author) - Matthe94@uni - Coventry.ac - Uk
Hannah June Matthews (Corresponding Author) - Matthe94@uni - Coventry.ac - Uk
Coventry University
Faculty of Health & Life Sciences
Priory Street
Coventry
United Kingdom
CV1 5FB
Coventry University
Faculty of Health and Life Sciences
Coventry
United Kingdom
Coventry University
Faculty of Health & Life Sciences
Coventry
United Kingdom
Key words: cancer, oncology, breast cancer, meta-analysis, mastectomy, and psychosocial
interventions.
This article has been accepted for publication and undergone full peer review but has not
been through the copyediting, typesetting, pagination and proofreading process which may
lead to differences between this version and the Version of Record. Please cite this article as
doi: 10.1002/pon.4199
Objective: Breast cancer is the most commonly diagnosed cancer in women across the world.
The majority of women diagnosed with the disease undergo surgery, which is often
associated with significant psychosocial morbidity. The aim of this meta-analysis was to
identify the efficacy of psychosocial interventions for women following breast cancer
surgery.
Method: A comprehensive literature search was undertaken using keyword and subject
headings within seven databases. Included studies employed a quantitative methodology
presenting empirical findings focusing on interventions for female breast cancer patients
following surgery.
Results: 32 studies were included and based on conventional values of effect sizes, small
effects emerged for the efficacy of psychosocial interventions in relation to anxiety (Hedges
g=0.31), depression (0.38), quality of life (0.40), mood disturbance (0.31), distress (0.27),
body image (0.40), self-esteem (0.35), and sexual functioning (0.22). A moderate to large
effect emerged for the efficacy of interventions in promoting improvements in sleep
disturbance (0.67). Clear evidence emerged for the efficacy of cognitive behavioural therapy
in promoting improvements in anxiety, depression and quality of life.
(250 words)
Introduction
Breast cancer is the most commonly diagnosed cancer in women across the world [1]. It is
estimated that one out of every eight women will develop breast cancer at some point in their
lives [2]. Mortality rates have fallen over recent decades partly due to advances in early
detection and treatment [3] resulting in a growing cohort of breast cancer survivors [4].
Improved survival rates have placed increased importance on promoting and supporting a
high quality of life and optimal psychosocial adjustment among breast cancer patients. The
primary treatment for breast cancer is surgical consisting of either a mastectomy or breast
conservation surgery [1]. Following mastectomy approximately one third of women choose
to undergo immediate breast reconstruction [5] in order to reconstruct or reshape the breast
mound.
The past decade has seen an increase in the development of interventions to reduce
psychosocial morbidity and improve coping and adjustment following breast cancer
treatment. Psychosocial interventions are broadly defined as any supportive interaction
involving two or more individuals whose purpose is to promote awareness and education,
provide emotional support, encouragement, and assist with problem solving [10].
Psychosocial interventions that have been utilised with breast cancer patients following
surgery include group therapy, individual counselling, psychotherapy, and psychoeducational
interventions [11, 12]. Generally, such interventions have only focused on a limited number
of patient outcomes, including anxiety, depression, and quality of life. Nevertheless,
accumulating evidence indicates psychosocial interventions provide a consistent
beneficial effect for cancer patients [13] and specifically breast cancer patients [11].
However, little is known about which intervention is most effective following breast
cancer surgery. The aim of this systematic review and meta-analysis was to evaluate the
efficacy of interventions on a range of psychosocial outcomes following surgical treatment
for breast cancer, both mastectomy and breast conservation surgery.
Methods
Inclusion criteria were as follows: (i) female adult breast cancer survivors; (ii) any type of
primary breast cancer surgery including mastectomy and breast conservation surgery ;(iii)
psychological, psycho-educational and/or psychosocial intervention; (iv) written in English;
(v) quantitative methodology; (vi) presenting empirical findings. Studies were excluded if
interventions focused on physical rehabilitation, physiological outcomes, palliative and/or
metastatic breast cancer, were published as a conference abstract or a case study. A backward
(reference) search was performed which involved hand searching the reference list of articles
included in the analysis. A forward (citation) search was also performed using Scopus.
Additionally, as part of the systematic search procedure, review articles were also
obtained and examined in order to identify any additional articles.
Two blinded raters (HM & EG) independently applied a 14 item quality assessment
checklist from a standardised quality assessment tool to each study [14]. Discrepancies
were systematically resolved by consensus. Each study was assessed against the 14 items
using a three point scale (2-fully met criterion, 1-partially met and 0-did not meet the
criterion). A total score was calculated by summing the number of yes responses,
multiplying this by 2 and adding this to the number of partials. If a criterion was not
applicable it was excluded from the score calculation. The total possible score was calculated
as 28 minus 2 times the number of not applicable. Lastly, a summary score (total sum/total
possible sum) was calculated representing the methodological quality of each article. These
scores were calculated as a linear score from 0-100 and divided into three categories
representing low, moderate, or high quality studies. Studies with a score of 75 or more were
considered high quality, moderate quality 50-74, and low quality 49 or less.
Meta-analysis strategy
We used hedges g as the effect size statistic. Hedges g calculates the difference between
intervention and control group means (d) divided by the pooled standard deviation (SD)
multiplied by factor (J) that corrects the underestimation of the population SD [15]. Through
pooling variances, hedges g standardises outcomes across studies and allows for
comparison among disparate outcome measures. Effect size calculations used a random
effects model. This assumes that analysed studies represent a random sample of effect
sizes, subsequently facilitating the generalisability of results [16]. The heterogeneity
between studies was calculated using the heterogeneity I2 statistic. The I2 statistic
calculates what proportion (0-100%) of the observed variance reflects variance in true
effect sizes, rather than sampling error. A value of 0% represents no observed
heterogeneity, an I2 value of 25%, 50%, and 75% tentatively signify low, moderate, and
Sources of bias
Mean effects for each outcome were assessed for the degree of publication bias (the
preferential publication of studies with positive effects). Publication bias was assessed
using two techniques: the examination of the funnel plot and estimates of correction,
trim and fill. If the points on the funnel plot are evenly distributed between positive and
negative effects, bias is lacking within the meta-analysis. If publication bias existis a
disproportionate number of studies will fall to the bottom right of the plot [20]. The
trim and fill method attempts to estimate the number of missing studies that may exist
in the meta-analysis and correct for funnel plot asymmetry [20]. Orwins fail-safe N was
also calculated to assess the roboustness of the overall effect [21]. This will determine
the number of studies with a null effect size required to reduce the overall effect to non-
signficiance. In this meta-analysis the number of studies is represented by k.
The search strategy identified 3,817 records, reduced to 1,455 unique articles following the
exclusion of duplicates and to 19 articles following the application of the inclusion and
exclusion criteria (Figure 1). A backwards search identified 8 additional articles and a
forward search identified 7 further articles, totalling 34 articles. Twenty-one articles were
classified as high quality, eleven as moderate quality and two as low quality (Table 1). The
two low quality articles were removed from the review. In total, 32 articles were included in
the review. Twenty-two studies utilised a randomised controlled trial design, 5 pre and post
group evaluations, 2 non-randomised controlled studies, 2 single cohort pre & post
evaluations, and 1 randomised & comparative study design. Follow-up periods ranged from 1
to 36 months with between two and six data collection points.
Participant and design characteristics of the 32 studies included in this review are
summarised in Table 1, and outcome and assessment measures are described in detail in
Table 3, assessiable as online supplementary materials. This review comprised of 32
psychosocial interventions with eight studies utilising cognitive behavioural therapy
interventions [10, 22, 23, 24, 25, 26, 27, 28], seven psychoeducational interventions [29, 30,
31, 32, 33, 34, 35], four support groups [36, 37, 38, 39], three counselling interventions [40,
41, 42], two mindfulness based stress reduction interventions [43, 44], two supportive
expressive group therapy interventions [45, 46], one psychosexual intervention [47],one
music therapy and progressive muscle relaxation training [48] and one contemplative self-
healing intervention [49]. The review also included two studies which combined
psychoeducational interventions and peer and social support interventions [50, 51] and one
Insert Table 1. Systematic review of psychosocial interventions for women after breast cancer
surgery (k=32)
Anxiety
Eight of thirteen studies reported a significant reduction in anxiety following the intervention
[23, 27, 39, 44, 45, 46, 47, 48]. Whilst, two studies demonstrated significant effects with
cognitive behavioural therapy on anxiety [23, 27], two studies reported no significant effects
with cognitive behavioural therapy [10, 26]. Counselling interventions also failed to
demonstrate significant treatment effects on anxiety [32, 40, 42]. Moreover, Kimman and
colleagues [32] reported no significant treatment effects of a telephone educational
intervention on anxiety.
Depression
Quality of life
Thirteen studies reported improved quality of life across a range of interventions including,
contemplative self-healing intervention [49], psychoeducational interventions [31],
mindfulness based stress reduction [43], cognitive behavioural therapy [34, 25, 26, 27, 42],
and combined interventions utilising psychoeducational, cognitive behavioural therapy and
social support [3] and a psychoeducational and peer support intervention [50].Support
groups [37], and two psychoeducational interventions [32, 33] reported no significant
treatment effects on quality of life.
Mood disturbance
Body image
Two studies reported significant treatment effects with cognitive behavioural therapy [24],
and support groups [37]. In contrast, no significant treatment effect on body image was
observed for supportive expressive group therapy [46].
Sleep disturbance
Two studies reported improved sleep utilising supportive expressive group therapy [46], and
cognitive behavioural therapy [27]. One study reported a reduction in sleep disturbance was
associated with decreased anxiety, depression and improved global quality of life [31].
Self-esteem
Sexual functioning
Meta-analysis results
Weighted average effect sizes for each outcome are displayed in Table 2 and forest plots
are displayed in Figure 2. Additionally, Table 2 details results of analyses to detect
publication bias and heterogeneity statistics for each of the psychosocial outcomes.
Meta-regression indicated that the number of sessions within a intervention was not a
significant moderator of depression (k=10;B=0.006;P=0.49), nor was quality of life
(k=11;B=-0.016;P =0.08). However, the number of sessions was a significant moderator
for anxiety (k=9;B=0.015; P=0.04). In regards to publication bias, all funnel plots
displayed a greater number of studies to the right of the mean. However, as a
disproportionate number of studies did not fall to the bottom right of the plot, this
suggests systematic bias does not significantly contribute to our estimate of the efficacy
of interventions in relation to psychosocial outcomes. Funnel plots are displayed in
Insert Table 2. Mean effect sizes for psychosocial outcomes for studies with sufficient data
for the meta-analysis.
Insert Figure 2. Forest plots of effect sizes for studies assessing psychosocial outcomes.
Discussion
To our knowledge, this is the first meta-analysis to evaluate the efficacy of interventions on a
range of psychosocial outcomes in breast cancer patients. The meta-analysis demonstrated
small effect sizes on eight psychosocial outcomes: anxiety, depression, quality of life,
mood disturbance, distress, body image, self-esteem, and sexual functioning. A
moderate to large effect size was detected on sleep disturbance. Within this meta-analysis
anxiety (k=14), depression (k=14) and quality of life (k=13) were the most commonly
reported outcomes. This is not surprising given the high incidence of anxiety and depression
after surgical treatment for breast cancer, with as many as 30% of women reporting to
experience anxiety and depression [6], and the widely recognised impact of anxiety and
depression on quality of life [7]. Moreover, cognitive behavioural therapy was the most
common intervention for both anxiety and depression, often reporting significant treatment
effects [22, 23, 25, 26, 27]. This meta-analysis provides clear evidence for the efficacy of
cognitive behavioural therapy in improving outcomes in relation to anxiety [10, 23, 37, 39],
depression [22, 25, 26, 37], and quality of life [25, 26, 27, 28]. Meta-regression indicated
the number of sessions was not a significant moderator of depression or quality of life,
although we can conclude the number of sessions is related to effect size for the outcome
anxiety. However, we cannot conclude if the length of the sessions moderated the effect
size, nor the timing of the intervention or who delivered the intervention, as a large
portiotion of the studies did not report significant details of the interventions. This
should be addressed in future research in order to develop effective evidence based
interventions to enhance breast cancer care.
The quality of both the systematic review and meta-analysis is dependent on the quality of
studies analysed. One review suggests the more rigorous the review the less likely it is to
conclude there is evidence psychosocial interventions in oncology are effective [54].
Consequently, the design of the studies included must be considered. Whilst, the majority of
studies utilised a randomised controlled trial study design, a number of studies employed a
pre and post-test design. Therefore, in the studies which employed a pre and post-test design
the findings may be attributed to changes which occurred independently to the intervention,
for example increased support from family members may improve psychosocial wellbeing. A
number of studies acknowledge an absence in randomisation and/or the process of
randomisation did not result in equity between groups. Therefore, further evidence with
randomised controlled trial study designs may be required to confirm significant treatment
effects are not linked to weaker study design. This meta-analysis did not include
unplublished studies, as we considered published peer-reviewed studies would provide
the strongest evidence regarding the efficacy of psychosocial interventions. However, we
recognise effect sizes may be overestimated with the absence of publication of null
findings. This review also reported both primary and secondary outcomes of studies
within the meta-anlaysis. Subsequently, we acknowledge the possibility of reporting
small effect sizes for secondary outcomes. Seven studies were excluded because the
published data were not suitable for meta-analysis, and the required data could not be
obtained from the authors [11, 23, 25, 37, 39, 44, 48].
The studies included in this meta-analysis present a number of limitations. The majority of
the studies recruited a sample of highly educated, middle class white women who were likely
to be motivated to participate in health research. Furthermore, three studies [26, 30, 45]
utilised samples with clinically depressed and highly distressed participants, another study
included women experiencing chronic insomnia [27]. Consequently a significant
improvement is more likely, as participants who experience considerable psychological
symptoms may be more likely to engage in interventions and hence benefit more from the
intervention, enhancing the likelihood of detecting significant treatment effects [55]. We
recommend that researchers should be aware of the sample when assessing the findings.
Future studies may want to consider screening for psychological symptoms and
Seven studies acknowledged limited generalisability from small sample sizes (n<50), and
hence were underpowered to evaluate changes in the multiple outcomes that were measured
[25, 36, 38, 40, 46, 47, 49]. Notably, studies with low statistical power have a reduced chance
of detecting a true effect [56]. A number of studies also reported limited generalizability from
single centre trials, due to the use of a single highly trained therapist within the interventions.
Furthermore, many of the interventions included multiple components, subsequently it is
often not possible to determine which component an improvement is attributable too. As
Czaja and colleagues [58] acknowledged the decomposition of psychosocial interventions to
identify effective components is an important goal within the field of psycho-oncology and
should be addressed in future studies. Moreover, no studies included in this meta-analysis
evaluated the cost effectiveness of interventions. However, there is a pressing need for
studies to address cost issues for breast cancer interventions to determine if the initinal
intervention cost becomes cost-effective overtime [56]. For example a reduction in the
number of GP visits, may result in overall cost-effectiveness of an intervention [57]. We
recommend future investigators to consider the cost-effectiveness of interventions,
particularly considering different modes of administration (i.e. in-person or over the phone)
in order to provide efficient and cost effective support.
This is the first meta-analysis to evaluate the efficacy of interventions to improve a range of
psychosocial outcomes following breast cancer surgery. This meta-analysis has demonstrated
the efficacy of cognitive behaviour therapy in improving outcomes in relation to anxiety,
depression and quality of life. This meta-analysis is of significant importance given the
potential widespread integration of evidenced-based psychosocial interventions in clinical
cancer care. Future research priorities should focus on strengthening studies both
conceptually and methodologically, in order to meaningfully pool data to determine which
intervention components are required to enhance breast cancer suvivourship. Currently robust
conclusions cannot be determined surrounding the efficacy of different types of psychosocial
interventions. However, this meta-analysis provides a methodical, novel and secure evidence
base for the efficacy of cognitive behavioural therapy on anxiety, depression and quality of
life following breast cancer surgery.
Funding
This research received no specific grant from any funding agency in the public, commericial
or not-for-profit sectors. It was completed as part of a doctoral programme of study.
Conflict of Interest
References
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