162 Journal of Pain and Symptom Management Vol. 53 No. 2 February 2017 Original Article Dignity Therapy and Life Review for Palliative Care Patients: A Randomized Controlled Trial Dean Vuksanovic, MClinPsych, Heather J. Green, PhD, Murray Dyck, PhD, and Shirley A. Morrissey, PhD Menzies Health Institute Queensland and School of Applied Psychology, Griffith University, Gold Coast Campus, Southport, Queensland, Australia Abstract Context. Dignity therapy (DT) is a psychotherapeutic intervention with increasing evidence of acceptability and utility in palliative care settings. Objectives. The aim of this study was to evaluate the legacy creation component of DT by comparing this intervention with life review (LR) and waitlist control (WC) groups. Methods. Seventy adults with advanced terminal disease were randomly allocated to DT, LR, or WC followed by DT, of which 56 completed the study protocol. LR followed an identical protocol to DT except that no legacy document was created in LR. Primary outcome measures were the Brief Generativity and Ego-Integrity Questionnaire, Patient Dignity Inventory, Functional Assessment of Cancer Therapy-General, version 4, and treatment evaluation questionnaires. Results. Unlike LR and WC groups, DT recipients demonstrated significantly increased generativity and ego-integrity scores at study completion. There were no significant changes for dignity-related distress or physical, social, emotional, and functional well-being among the three groups. There were also no significant changes in primary outcomes after the provision of DT after the waiting period in the WC group. High acceptability and satisfaction with interventions were noted for recipients of both DT and LR and family/carers of DT participants. Conclusion. This study provides initial evidence that the specific process of legacy creation is able to positively affect sense of generativity, meaning, and acceptance near end of life. High acceptability and satisfaction rates for both DT and LR and positive impacts on families/carers of DT participants provide additional support for clinical utility of these interventions. Further evaluation of specific mechanisms of change post-intervention is required given DT’s uncertain efficacy on other primary outcomes. J Pain Symptom Manage 2017;53:162e170 Ó 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved. Key Words Dignity therapy, life review, randomized controlled trial, RCT, palliative Introduction Palliative care patients are at increased risk of experiencing psychological, social, and spiritual distress associated with the impacts of their advancing disease.1e5 Provision of psychosocial care is an integral part of contemporary palliative care whose aim is to meet complex multifaceted needs of terminally ill patients and their families/carers. However, there is Address correspondence to: Dean Vuksanovic, MClinPsych, Gold Coast University Hospital, Parklands Drive, Southport, Queensland 4215, Australia. E-mail: Dean.Vuksanovic@ health.qld.gov.au Ó 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved. evidence that palliative care clinicians are insufficiently prepared to assess and treat psychosocial distress, and there is no established consensus on what constitutes quality existential and spiritual care.1e4 Although the evidence base is growing for systematically developed, manualized psychotherapeutic interventions aimed at addressing existential and spiritual suffering near end of life, it remains to be seen whether any one intervention is superior to others.5 Accepted for publication: September 6, 2016. 0885-3924/$ - see front matter http://dx.doi.org/10.1016/j.jpainsymman.2016.09.005 Vol. 53 No. 2 February 2017 Dignity Therapy and Life Review RCT One psychotherapeutic intervention with an increasing evidence of its utility and acceptability in palliative care settings is dignity therapy (DT). The broad aim of this intervention was to bolster psychosocial, emotional, and existential well-being through the process of life review (LR) and creating a lasting legacy document that typically contains important or meaningful memories, values, words of wisdom, and special messages to loved ones. DT is specifically tailored to palliative patients by 1) being grounded in an empirical model of dignity that was specifically developed with this patient population, 2) placing less emphasis on insight and skill building, and instead enhancing meaning, purpose, and sense of dignity, and 3) being relatively brief and flexible. A recent systematic review6 found that DT has exceptionally high acceptability and satisfaction rates, variable feasibility due to recruitment and retention issues, and uncertain effectiveness because of a general absence of effects on primary outcome measures immediately after intervention. Demonstrating therapeutic outcomes was further complicated by participants’ relatively low initial distress levels and resulting ceiling or floor effects of outcome measures. The authors concluded that further clinical feasibility studies are required along using outcome measures that place less emphasis on physical symptoms/functions and more emphasis on specific existential, spiritual, and social aspects of patients’ experiences at variable time intervals. LR is a brief psychotherapy suitable for use in palliative care settings. Typically, a graduated review of the lifespan is conducted with goals of addressing or processing the person’s life experiences, finding meaning in life and achieving ego-integrity.7,8 A recent systematic review9 has found that LR interventions are viable and ‘‘probably efficacious’’ in palliative care although it was noted that issues with patient attrition rates, floor/ceiling effects of outcome measures, and generally limited empirical evidence are key barriers to wider adoption of these interventions into clinical practice. The aims of this study were to compare DT with LR and a waitlist control (WC) group on a range of outcome measures. The LR intervention in this study was delivered in an identical manner to DT except that no legacy document was generated, thus allowing for an unprecedented evaluation of this unique aspect of DT. The WC group also received DT after a set waiting period, allowing for controlled within-group comparisons. It was hypothesized that DT would be superior to the other groups on a measure of generativity and that DT and LR would be superior to a WC group before active treatment on the measures of ego-integrity, dignity, and perceived quality of life. Participant and family/carer satisfaction with interventions were explored. 163 Methods Design A randomized controlled trial was used to enroll a sample of 70 participants to DT, LR, or a WC group. Participants were randomized after the completion of self-report measures at pre-test. Subsequent assessments were completed when interventions finished or after a 10-day waiting period for the WC group (post-test). This waiting period approximated the average DT/LR intervention time and reduced the risk of increased attrition rate and subsequent inflated benefits of intervention groups because of patient deterioration. WC participants then completed assessments after DT (post-test 2). This study was approved by university and hospital research ethics committees, and all participants provided written informed consent. Participants Inclusion criteria were 1) at least 18 years old, 2) diagnosed with advanced disease with a life expectancy of less than 12 months based on clinical consensus, 3) receiving specialist multidisciplinary palliative care either in a hospital or home setting, 4) able to communicate in English and provide consent, and 5) able to commit to up to four contacts over w10 days during active interventions. Exclusion criteria were illness severity that precluded protocol completion; significant cognitive impairment based on clinical consensus, and, if applicable, cognitive assessment or previous intervention from the primary investigator in his clinical psychologist role. Measures The Brief Measure of Generativity and Ego-Integrity10 (Appendix I) is an 11-item measure of Erik Erikson’s concepts of generativity and ego-integrity with good internal consistency that was developed for use in palliative care settings. Generativity refers to care and concern for future generations, maintaining productivity and a sense of leaving a lasting legacy. Egointegrity refers to looking back on life with a sense of meaning, acceptance of past events, sense of growing wise with age, and general absence of death anxiety. Factor analysis of the current sample demonstrated the same two-factor structure as the scale development sample, except that one item proposed for the generativity scale did not load on either factor and was removed from subsequent analyses (Item 5). Responses from 1 ¼ strongly disagree to 5 ¼ strongly agree are averaged across subscales, with reverse scoring when necessary, so that higher subscale means indicate higher levels of generativity and ego-integrity. The Patient Dignity Inventory (PDI) is a reliable and valid 25-item measure of dignity-related distress 164 Vuksanovic et al. that is based on the empirical model of dignity.11 The PDI has a total scale ranging from 25 to 125 where higher scores indicate greater distress. Perceived quality of life was measured by the Functional Assessment of Cancer Therapy-General, version 4 (FACT-G12). The FACT-G contains 27 items divided into four primary quality of life domains: physical well-being, social/family well-being, emotional wellbeing, and functional well-being. Higher scores indicate better perceived well-being. The FACT-G has established psychometric properties with good reliability and validity and it is appropriate for use with patients with cancer and other chronic illness conditions.13,14 A Treatment Evaluation Form (15 items) measured participants’ beliefs about the impacts of DT or LR on their well-being and that of their family/carers. A Family Evaluation Form (15 items) measured family/carer perceptions of impacts of DT on themselves and the participant. Both measures were modeled on participant feedback questionnaires used in previous DT studies.15 Four clinician-rated measures of well-being were administered at baseline and post-test based on clinical consensus of participants’ medical treating team: 1) Palliative Care Phase Instrument, 2) AustraliaModified Karnofsky Performance Scale, 3) Resource Utilization GroupsdActivities of Daily Living, and 4) Vol. 53 No. 2 February 2017 Problem Severity Score (PSS). These measures are part of an Australian palliative care outcomes and benchmarking system16 that were used as standard practice by the medical setting in which this study was conducted. Procedure Seventy participants were recruited from March 2012 to December 2015, of which 56 completed the study protocol. Eligible patients were informed about the study by a member of their treating team and chose whether to consent to contact from the first author. The first session involved the provision of informed consent and baseline assessment conducted by a clinician or student not affiliated with this study. Alternatively, if study participation occurred in a home setting, participants self-completed the questionnaires or mailed them in. Participants were then randomly assigned to DT, LR, or WC groups by block randomization with a fixed block size of 6. Allocation concealment used sequentially numbered sealed envelopes for consecutive eligible participants. Figure 1 shows the participant flow for this study. Intervention Groups DT was provided by the first author, a clinical psychologist experienced in working with advanced Fig. 1. CONSORT diagram. Vol. 53 No. 2 February 2017 Dignity Therapy and Life Review RCT cancer patients. The therapist attended two 3-day DT training workshops conducted by Harvey Chochinov whose research team developed DT and used therapy resources that were either provided as part of training or published elsewhere. Protocol adherence and a random sample of completed session transcripts were reviewed by an external supervisor experienced in providing DT supervision. Participants were given the DT question framework and asked to consider what they may wish to talk about. The second meeting was scheduled as soon as it could be arranged. The standard framework of questions17 provided a flexible guide for the interview in which disclosure of thoughts, feelings, and memories was facilitated. Both DT and LR sessions were audiorecorded and transcribed verbatim by a research assistant or occasionally the first author within 48 hours. The DT transcript then underwent an editing process and was reviewed with participants in a follow-up session. The finalized version of their legacy document was returned to participants, to be passed along to a recipient of their choice. LR was also provided by the first author. The LR protocol, recording and transcription, were identical to DT with the exception that the legacy document was not generated or provided to participants. Questions used in DT that specifically mentioned a legacy document were excluded from the LR protocol. Participants in the WC group were provided with standard DT after the completion of their 10-day waiting period. There were no significant differences between the three groups in the length of therapy sessions in minutes (MDT ¼ 58.05 [SD ¼ 30.71], MLR ¼ 54.29 [SD ¼ 10.33], MWC ¼ 61.39 [SD ¼ 25], or the word count of audio transcripts (MDT ¼ 4089 [SD ¼ 2556], MLR ¼ 4731 [SD ¼ 2525], MWC ¼ 3866 [SD ¼ 1018]. Statistical Analyses Participants who completed the study protocol were included in statistical analyses (SPSS, version 21). A series of 3  2 ANOVAs were conducted for the primary outcome measures using Group (DT vs. LR vs. WC) and Trial (pre-test vs. post-test) as independent variables. One-way repeated-measures ANOVAs were performed to further assess changes in the primary outcome measures for the WC participants across the three time periods. Relevant assumptions were met; minor departures from homogeneity of variances were not considered problematic. In significant interaction effects, simple effects were examined when a normal distribution was reasonably approximated. All comparisons were done on a 2-tailed basis. With an alpha set at 0.05, a desired power set at 0.80, and a large effect size using Cohen’s value for such an 165 effect size of 0.8, the estimated recruitment target was 26 participants per arm (GPower, version 3.1). Results Table 1 shows that the demographic characteristics and clinician ratings were generally well balanced at baseline. Thirty-one of the 56 participants were women. The mean age was 57.7 years (range ¼ 25e83) and 33 participants (58.9%) were married or in defacto relationships. The median number of children in each group was two with four participants (7.1%) having no children. Thirty-seven participants (66.1%) were seen as outpatients or at home, and the rest were seen at inpatient wards. Thirty-one participants (55.4%) were religiously affiliated and 53 (94.6%) did not work or were retired. Thirty-nine participants (69.6%) completed high school, 15 (26.8%) completed at least some tertiary education, whereas three did not complete high school. Table 1 demonstrates that a range of malignancies were present, with only two participants having nonmalignant conditions. No differences were found in median survival times after study completion between the three groups (87 days [range ¼ 8e455] in the DT group; 88 days [range ¼ 10e412] in the LR group, and 73 days [range ¼ 23e495] in the WC group). There were no significant differences between the three groups or between baseline and post-test scores in each group on the Palliative Care Phase Instrument, Australia-Modified Karnofsky Performance Scale, and Resource Utilization GroupsdActivities of Daily Living measures. On the PSS at pre-test, WC participants had significantly lower scores than DT participants (but not LR participants) on the following subscales: pain, t(36) ¼ 2.12, P ¼ 0.04; other, t(36) ¼ 3.04, P ¼ 0.004; and psychological/spiritual, t(36) ¼ 2.67, P ¼ 0.01. There were no other significant differences on the PSS. More WC participants reported being involved in or completing other legacy activities (55.6%) compared with DT (35%) and LR (22.2%) participants. Such activities included collating photographs and other personal items, writing letters or cards for family members, and arranging special gifts. No participants previously took part in DT, LR, or similar interventions. Impacts of Interventions on Generativity and EgoIntegrity Scores There was a significant group  trial interaction for generativity, F (2, 53) ¼ 8.73, P ¼ 0.001, partial h2 ¼ 0.25. Simple effects analysis showed that participants in the DT group had significantly higher generativity factor scores at completion of the study (95% CI 2.67, 3.41) compared with baseline (95% CI 3.52, 4.15, 166 Vuksanovic et al. Vol. 53 No. 2 February 2017 Table 1 Demographic Characteristics and Clinician Ratings of Participants at Baselinea Age Gender (Female) Marital status Married Separated/divorced Widowed Defacto Never married No. of children Care setting Inpatient palliative care Outpatient or home Religion Catholic Anglican Other (Christian) Other (non-Christian) No religion Living arrangement Alone Spouse Other family/friends Working arrangement Working and/or studying Semi-working/semi-retired Not working/retired Education Did not complete high school Completed high school One or more years of tertiary education Primary cancer site Lung Breast Gastrointestinal Genitourinary Haematological Brain Other solid tumors Nonmalignant PCPI (pre-test) Stable Unstable Deteriorating Terminal AKPS (pre-test)b RUG-ADL (pre-test)c Problem Severity Score (pre-test)d Pain Other symptoms Psychological and spiritual Family/carer Other legacy activities Yes No Dignity Therapy (n ¼ 20) Life Review (n ¼ 18) Waitlist Control (n ¼ 18) 55.95 (14.45) 11 (55%) 62.33 (16.16) 9 (50%) 54.94 (13.80) 11 (61.1%) 13 3 1 1 2 2 (65%) (15%) (5%) (5%) (10%) (0e4) 8 (40%) 12 (60%) 4 3 1 1 11 7 7 3 1 (38.9%) (38.9%) (16.7%) (5.6%) 0 2 (0e4) 7 (38.9%) 11 (61.1%) 10 6 1 1 (55.6%) (33.3%) (5.6%) (5.6%) 0 2 (0e5) 4 (22.2%) 14 (77.8%) (20%) (15%) (5%) (5%) (55%) 5 (27.8%) 3 (16.7%) 2 (11.2%) 0 8 (44.4%) 2 (10%) 13 (65%) 5 (25%) 4 (22.2%) 7 (38.9%) 7 (38.9%) 5 (27.8%) 10 (55.6%) 3 (16.7%) 0 1 (5%) 19 (95%) 0 1 (5.6%) 17 (94.4%) 0 1 (5.6%) 17 (94.4%) 1 (5%) 16 (80%) 3 (15%) 0 14 (77.8%) 4 (22.2%) 1 (5.6%) 9 (50%) 8 (44.4%) 5 4 4 1 1 2 2 1 (25%) (20%) (20%) (5%) (5%) (10%) (10%) (5%) 16 (80%) 4 (20%) 0 0 51 (11.19) 7.70 (3.85) 2.70 2.90 2.35 2.15 (0.66) (0.31) (0.59) (0.93) 7 (35%) 13 (65%) 3 2 6 5 (16.7%) (11.2%) (33.3%) (27.8%) 0 0 1 (5.6%) 1 (5.6%) 13 (72.2%) 5 (27.8%) 0 0 53.33 (12.38) 7.33 (3.94) 2.56 2.67 2.00 2.44 (0.86) (0.84) (0.84) (0.71) 4 (22.2%) 14 (77.8%) 4 3 4 1 6 (22.2%) (16.7%) (22.2%) (5.6%) (33.3%) 3 8 5 1 (16.7%) (44.4%) (27.8%) (5.6%) 0 1 (5.6%) 0 0 15 (83.3%) 3 (16.7%) 0 0 57.78 (9.43) 6.00 (1.91) 2.22 2.22 1.78 2.00 (0.73) (0.94) (0.73) (0.77) 10 (55.6%) 8 (44.4%) a Data are mean (SD), number (%) or median (range). Score range 0 ¼ dead to 100 ¼ normal performance status. Score range 4 ¼ independent functioning to 18 ¼ requires two or more assistants for bed mobility, toileting, transfers and eating. d 1 ¼ absent, 2 ¼ mild, 3 ¼ moderate, and 4 ¼ severe. b c P < 0.001). No significant changes in generativity were found for LR and WC participants. There was also a significant group  trial interaction for ego-integrity, F (2, 53) ¼ 3.20, P ¼ 0.049, partial h2 ¼ 0.11. Participants in the DT group had significantly higher egointegrity scores at study completion (95% CI 3.17, 3.77) compared with baseline (95% CI 3.48, 4.22), P ¼ 0.01. No significant changes in ego-integrity scores were found for LR and WC participants. Figure 2 shows the group differences in generativity and egointegrity estimated marginal means. An analysis of generativity and ego-integrity scores for the WC Vol. 53 No. 2 February 2017 Dignity Therapy and Life Review RCT 167 Fig. 2. Generativity and ego-integrity estimated marginal means across treatment groups and testing times. Post-test for the WC group refers to the end of the waiting period. participants across three time periods (pre-test vs. post-test vs. post-test 2) found no significant changes in these measures. Impact of Intervention Groups on PDI and FACT-G Scores Table 2 lists the sources of distress measured by the PDI across testing times for each intervention group. There were no significant differences found between the three study groups on the individual PDI items or the total PDI scores. Within the WC group, there were no significant changes in the total PDI scores across the three assessment points. There were no main effects of group on the FACT-G subscale scores with the exception of the Functional Well-Being subscale where the WC group scored significantly higher compared with the other two groups, F (2, 53) ¼ 5.06, P ¼ 0.01; MDT ¼ 10.18, MLR ¼ 12.11, MWC ¼ 15.94. Within the WC group, there were no significant changes in the FACT-G subscale scores across the three trial periods. Treatment Evaluation Treatment evaluation scores were combined for DT and WC participants given that they received identical interventions and the scores did not significantly differ between these two groups. DT was rated as significantly more helpful than LR in being helpful to the participant’s family now or in the future (87.1% vs. 33.3%, respectively, t(44) ¼ 3.34, P ¼ 0.002) and in the way that their family saw or appreciated them (77.4% vs. 33.3%, t(44) ¼ 2.64, P ¼ 0.01). Both DT and LR were deemed to be helpful (83.9% vs. 86.7%, respectively), as helpful as other aspects of health care (74.2% vs. 73.3%), would be recommended to others (90.3% vs. 86.7%), made participants feel more valued or worthwhile (74.2% vs. 66.7%), improved sense of dignity (58.1% vs. 60%), made participants feel that life was more meaningful (74.2% vs. 73.3%), and resulted in a heightened sense of purpose (54.8% vs. 60%). Participants rated DT higher than LR on helping them prepare for the future (64.5% vs. 33.3%) and helping with unfinished business (64.5% vs. 40%) although these differences were not statistically significant. There were lesser group differences in quality of life (32.3% vs. 6.7%, respectively), spiritual well-being (48.4% vs. 20%), sadness or depression (32.3% vs. 26.7%), and suffering (32.3% vs. 26.7%). Fifteen family members or carers completed the Family Evaluation Form, of which 93.3% reported DT to be helpful, 66.7% that it changed the way they saw or appreciated their family member, and all family/carers stated they would recommend DT to others. With respect to the recipients of DT, their family/carers also reported that DT was helpful to them (100%), as helpful as other aspects of health care (80%), that it helped with unfinished business (60%), reduced sadness or depression (60%), made the person feel more worthwhile or valued (93.3%), improved sense of dignity (80%), made them feel that life was more meaningful (86.7%), heightened sense of purpose (86.7%), and helped them prepare for the future (73.3%). There were lesser improvements in family/carer ratings of participants’ quality of life (46.7%), spiritual well-being (53.3%), and suffering (33.3%). Discussion This is the first study to 1) compare Dignity Therapy to Life Review in a way that the legacy creation component of DT could be specifically evaluated, 2) use concepts of generativity and ego-integrity as primary outcome measures, and 3) use a Waitlist Control group that received DT after a set waiting period to measure longitudinal changes in treatment outcomes. Four important findings can be deduced from the data. First, DT participants demonstrated significantly greater improvements in their sense of generativity and ego-integrity than LR and WC groups, which 168 Vuksanovic et al. Vol. 53 No. 2 February 2017 Table 2 Dignity-Related Distress Measured by the PDI at Each Testing Timea Dignity Therapy (n ¼ 20) Item Not able to carry out tasks associated with daily living Not able to attend to bodily functions independently Physically distressing symptoms Change of appearance Feeling depressed Feeling anxious Feeling uncertain about health Worrying about the future Not being able to think clearly Not being able to continue with usual routines Feeling no longer who I was Not feeling worthwhile or valued Not able to carry out important roles Life no longer having meaning or purpose Not made a meaningful or lasting contribution in life Sense of ‘‘unfinished business’’ Spiritual life not meaningful Sense of burden to others No control over life Care needs have reduced privacy Not supported by community, friends or family Not supported by health care providers No longer able to mentally cope with challenges to health Not being able to accept the way things are Not treated with respect or understanding Life Review (n ¼ 18) Waitlist Control (n ¼ 20) Pre-test Post-test Pre-test Post-test Pre-test Post-test Post-test 2 (After Dignity Therapy) 3.00 (1.28) 2.70 (1.30) 2.89 (1.08) 2.44 (1.29) 2.22 (1.11) 2.39 (1.34) 2.28 (1.27) 2.50 (1.19) 2.45 (1.36) 2.5 (1.47) 2.28 (1.49) 2.00 (1.09) 2.17 (1.30) 2.11 (1.23) 2.95 2.25 2.35 2.40 3.00 3.00 2.80 3.45 2.75 2.15 1.95 2.20 2.80 2.70 2.70 2.95 3.06 2.17 1.89 2.33 2.50 2.50 2.50 2.67 2.44 1.72 1.78 1.83 2.17 1.94 1.78 2.22 2.50 1.89 1.56 1.94 2.11 2.06 2.00 2.28 2.44 2.28 1.89 2.06 2.44 2.33 2.22 2.44 (0.76) (1.02) (0.99) (1.00) (1.08) (1.12) (1.11) (0.95) (0.85) (1.04) (1.00) (1.06) (1.01) (1.17) (1.17) (0.76) 3.06 1.94 1.67 2.00 2.56 2.39 2.17 2.78 (1.00) (1.31) (0.97) (0.84) (1.20) (1.15) (1.34) (1.31) (1.26) (1.34) (1.13) (0.91) (0.99) (1.04) (1.38) (1.33) (1.20) (0.75) (1.17) (0.92) (0.99) (1.07) (1.00) (0.55) (1.10) (0.83) (0.62) (0.87) (1.02) (0.94) (1.09) (1.02) (1.25) (1.23) (0.76) (1.06) (1.10) (0.98) (1.17) (1.15) 2.40 (1.10) 1.55 (0.89) 3.20 (1.11) 2.45 (0.83) 1.60 (0.88) 3.00 (1.30) 2.78 (1.40) 1.89 (1.32) 2.28 (1.27) 2.33 (1.46) 1.72 (0.90) 2.56 (1.10) 1.89 (1.02) 1.33 (0.77) 2.56 (0.98) 1.94 (0.80) 1.50 (0.99) 2.39 (1.09) 2.39 (0.85) 1.72 (1.02) 2.22 (0.94) 2.05 (1.10) 1.75 (0.97) 2.06 (1.31) 1.89 (1.02) 1.33 (0.77) 1.39 (0.85) 1.39 (0.70) 1.95 (0.83) 1.60 (0.82) 1.78 (0.94) 1.72 (0.75) 1.50 (0.99) 1.67 (1.09) 1.56 (0.98) 2.45 1.25 2.80 2.50 2.00 1.55 2.25 1.35 2.70 2.45 2.15 1.35 2.33 1.17 2.44 2.28 1.72 1.72 2.33 1.33 2.50 2.33 1.89 2.00 2.28 1.17 1.83 1.89 1.61 1.06 2.61 1.22 2.06 2.11 1.56 1.11 2.11 1.33 2.00 2.39 1.72 1.28 (1.15) (0.72) (0.95) (0.89) (0.97) (0.83) (1.02) (0.67) (0.98) (0.83) (0.99) (0.59) (1.28) (0.51) (1.34) (1.13) (0.90) (1.13) (1.24) (0.59) (0.86) (1.03) (1.08) (1.09) (1.07) (0.38) (1.04) (0.96) (0.98) (0.24) (0.98) (0.43) (1.11) (1.08) (0.98) (0.32) (1.45) (0.49) (0.69) (0.78) (1.18) (0.58) 1.20 (0.41) 1.10 (0.31) 1.11 (0.32) 1.56 (0.98) 1.06 (0.24) 1.17 (0.51) 1.28 (0.46) 1.85 (0.93) 1.85 (0.67) 1.83 (0.99) 1.67 (0.77) 1.39 (0.78) 1.39 (0.78) 1.61 (0.98) 1.60 (0.82) 1.50 (1.09) 1.61 (1.34) 1.61 (1.09) 1.50 (0.86) 1.50 (0.78) 1.78 (0.88) 1.45 (0.76) 1.50 (0.83) 1.39 (0.70) 1.22 (0.43) 1.17 (0.38) 1.22 (0.43) 1.28 (0.58) a Data are mean (SD). A score of 1 indicates that the issue was not a problem; 2, a slight problem; 3, a problem; 4, a major problem; and 5, an overwhelming problem. supported the primary hypothesis. This suggests that the specific process of developing a legacy document that transcends own death has the potential to improve perceived productivity, guidance, and contribution to future generations and assist people in looking back on life with a sense of meaning and acceptance. Given Erikson’s18 conceptualization of these concepts as active and dynamic dichotomies (generativity vs. stagnation; ego-integrity vs. despair), DT also has the potential to reduce aspects of stagnation including apathy, poor contribution to others, and preoccupation with own needs and reduce aspects of despair such as guilt or regret about past events and a poor sense of accomplishment. There is evidence that increased sense of generativity and ego-integrity are positively associated with psychological and emotional well-being and negatively associated with depression.19,20 These mechanisms, therefore, need to be considered in explaining previous findings that DT is able to reduce anxiety and depressive features in more severely distressed participants, particularly in the short term.21 Of note is that the provision of DT in the WC group after the waiting period did not result in significant improvements on any outcomes. This group differed in some aspects to the DT group that randomization was unable to control, such as better functional well-being and better clinician ratings of pain, psychological/spiritual distress, and other symptoms. The WC group was also more likely than the others to have engaged in other memory or legacy activities before participation in this study, and it is possible that these activities may have had an indirect effect on the primary outcomes. Second, the hypothesis that LR would also improve sense of ego-integrity was not supported by the data. This suggests that quantifiable ego-integrity enhancement is dependent on more than a time-limited LR approach used in this study. An LR protocol with an Vol. 53 No. 2 February 2017 Dignity Therapy and Life Review RCT expanded scope and length may have resulted in enhanced treatment outcomes. It is also possible that LR resulted in participants discussing and evaluating aspects of their life that they otherwise may not have in DT sessions. Qualitative analyses of DT and LR interviews are needed to explore differences in session content between the two groups (to be reported separately). Third, there were no differences between the three groups on dignity-related distress and perceived quality of life outcomes including physical, social, emotional, and functional well-being. This finding is generally consistent with previous DT studies15,22,23 and likely reflects 1) the complex multifaceted nature of adjusting to the impacts of an advancing disease, 2) limitations of self-report measures in being able to capture psychosocial outcomes near end-of-life, further compounded by floor effects, and 3) the need for DT studies to have sufficient power to detect small to moderate effects in treatment outcomes. Fourth, both DT and LR interventions had high acceptability and satisfaction. Combined with the high satisfaction of family/carers of DT participants, this finding provides further evidence of the immediate and long-term benefits that generating a legacy document can have on individuals and their families/carers. 169 multidisciplinary backgrounds and across diverse settings, and 6) examination of LR family/carer outcomes post-intervention. Conclusion This study provides initial evidence that the specific process of legacy creation is able to positively impact sense of generativity and ego-integrity near end of life. No detectable changes in the sense of dignity or perceived quality of life after DT and LR underscores the need for further adequately powered research to delineate specific mechanisms of change following these interventions instead of reliance on broad outcome measures. The clinical utility of DT in particular is supported by the high acceptability and satisfaction rates among participants and their families/ carers. Disclosures and Acknowledgments The authors wish to thank all those who participated in this study. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The authors declare no conflicts of interest. Limitations One limitation of this study was the inadequate power to detect small effects given the modest sample size in each group and only mild-to-moderate levels of distress at baseline. The possibility of delayed treatment effects could not be excluded. Spiritual wellbeing, hopefulness, and clinical depression/anxiety items were incorporated into the outcome measures, but use of specific validated measures of these domains may have been warranted. Finally, participant expectancies may not have been equivalent across the three groups given the non-concealed intervention allocation, as is common in psychotherapeutic interventions. Implications for Future Research Identification, recruitment, and retention issues are common among DT studies to date but not unexpected in the wider palliative care context.24 Future studies need to consider 1) multimodal measurements of generativity and ego-integrity that involve behavioral indicators/changes, family perspectives, and qualitative examinations of therapy transcripts, 2) the potential impacts of pre-existing legacy activities on treatment outcomes, 3) post-treatment utilization of legacy documents, such as through social media, 4) inclusion of participants with higher levels of psychosocial distress, 5) involvement of clinicians from References 1. Boston P, Bruce A, Schreiber R. Existential suffering in the palliative care setting: an integrated literature review. J Pain Symptom Manage 2011;41:604e618. 2. Lawrie I, Lloyd-Williams M, Taylor F. How do palliative medicine physicians assess and manage depression. Palliat Med 2004;18:234e238. 3. Ng F, Crawford GB, Chur-Hansen A. How do palliative medicine specialists conceptualize depression? Findings from a qualitative in-depth interview study. J Palliat Med 2014;17:318e324. 4. Rainbird K, Perkins J, Sanson-Fisher R, Rolfe I, Anseline P. The needs of patients with advanced, incurable cancer. Br J Cancer 2009;101:759e764. 5. LeMay K, Wilson KG. Treatment of existential distress in life threatening illness: a review of manualized interventions. Clin Psychol Rev 2008;28:472e493. 6. Fitchett G, Emanuel L, Handzo G, Boyken L, Wilkie DJ. Care of the human spirit and the role of dignity therapy: a systematic review of dignity therapy research. BMC Palliat Care 2015;14:8. 7. Stinson CK, Kirk E. Structured reminiscence: an intervention to decrease depression and increase selftranscendence in older women. J Clin Nurs 2006;15: 208e218. 8. Trueman I, Parker J. Exploring community nurses’ perceptions of life review in palliative care. J Clin Nurs 2006; 15:197e207. 170 Vuksanovic et al. Vol. 53 No. 2 February 2017 9. Keall RM, Clayton JM, Butow PN. Therapeutic life review in palliative care: a systematic review of quantitative evaluations. J Pain Symptom Manag 2015;49:747e761. 17. Chochinov HM, Hack T, Hassard T, et al. Dignity therapy: a novel psychotherapeutic intervention for patients near the end of life. J Clin Oncol 2005;23:5520e5525. 10. Vuksanovic D, Dyck M, Green H. Development of a brief measure of generativity and ego-integrity for use in palliative care settings. Palliat Support Care 2015;13:1411e1415. 18. Erikson EH, Erikson JM. The life cycle completed: Extended version with new chapters on the ninth stage of development. New York: Norton & Comp, 1997. 11. Chochinov HM, Hassard T, McClement S, et al. The Patient Dignity Inventory: a novel way of measuring dignityrelated distress in palliative care. J Pain Symptom Manag 2008;36:559e571. 19. Rylands KJ, Rickwood DJ. Ego-integrity versus egodespair: the effect of ‘‘accepting the past’’ on depression in older women. Int J Aging Hum Dev 2001;53:75e89. 12. Cella DF, Tulsky DS, Gray G, et al. The Functional Assessment of Cancer Therapy Scale: development and validation of the general measure. J Clin Oncol 1993;11:570e579. 20. Song S, Cha S, Choi Y, Jung Y. Effects of grandparenting roles and generativity on depression among grandmothers providing care for grandchildren. Korean J Commun Living Sci 2015;26:387e403. 13. Overcash J, Extermann M, Parr J, Perry J, Balducci L. Validity and reliability of the FACT-G scale for use in the older person with cancer. Am J Clin Oncol 2001;24:591e596. 21. Juliao M, Oliveira F, Nunes B, Vaz Carneiro A, Barbosa A. Efficacy of dignity therapy on depression and anxiety in Portuguese terminally ill patients: a phase II randomized controlled trial. J Palliat Med 2014;17:688e695. 14. Webster K, Cella D, Yost K. The Functional Assessment of Chronic Illness Therapy (FACIT) measurement system: properties, application, and interpretation. Health Qual Life Outcomes 2003;1:79e86. 22. Bentley B, O’Connor M, Kane R, Breen LJ. Feasibility, acceptability, and potential effectiveness of dignity therapy for people with motor neurone disease. PLoS One 2014;9: e96888. 15. Chochinov HM, Kristjanson LJ, Breitbart W, et al. Effect of dignity therapy on distress and end-of-life experience in terminally ill patients: a randomised controlled trial. Lancet Oncol 2011;12:753e762. 23. Hall S, Goddard C, Opio D, Speck PW, Martin P, Higginson IJ. A novel approach to enhancing hope in patients with advanced cancer: a randomised phase II trial of dignity therapy. BMJ Support Palliat Care 2011;1:315e321. 16. Eagar K, Watters P, Currow DC, Aoun SM, Yates P. The Australian Palliative Care Outcomes Collaboration (PCOC)dmeasuring the quality and outcomes of palliative care on a routine basis. Aust Health Rev 2010;34:186e192. 24. Steinhauser KE, Clipp EC, Hays JC, et al. Identifying, recruiting, and retaining seriously-ill patients and their caregivers in longitudinal research. Palliat Med 2006;20: 745e754. Vol. 53 No. 2 February 2017 Dignity Therapy and Life Review RCT Appendix I Items Comprising the Brief Measure of Generativity and Ego-Integrity 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. I pass along the knowledge that I have gained through my experiences. I think that I will be remembered for a long time after I die. I am not making a meaningful and lasting contribution to other people. I am committed to many different kinds of people, groups, and activities. I have done nothing that will survive after I die. Other people would say that I am very productive. I feel contented with what I have accomplished in my life. I still feel angry about some of my life experiences. My life has been fulfilling, and I am not frightened by the thought of death. When I consider the ups and downs of my past life, they somehow fit together in a meaningful way. I have had disappointments in life that I will never be able to accept. 170.e1