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Abstract
Main objective To assess the ability of dignity therapy to reduce distress in advanced cancer patients.
Design A phase II open-label trial.
Setting Two UK National Health Service trusts.
Participants 45 adults with advanced cancer.
Intervention Dignity therapy: a brief palliative care psychotherapy.
Methods Participants were randomly allocated to receive the intervention plus standard care or standard care only (control group). Outcomes were collected at baseline and at 1- and 4-week follow-up.
Main outcome measures The primary outcome was dignity-related distress (Palliative Dignity Inventory). Secondary outcomes were hope, anxiety and depression, quality of life, palliative-related outcomes, and self-reported study benefits.
Results 45/188 (24%) patients responded. 27/45 (60%) participants remained at 1-week and 20/45 (44%) at 4-week follow-up. Baseline levels of distress were low. Groups did not differ in dignity-related distress at any time. An effect on only one secondary outcome was found: the intervention group reported more hope than the control group at both follow-ups. Effect sizes were medium (partial η2=0.20 and 0.15) and the difference was statistically significant at 1-week follow-up (difference in adjusted means 2.55; 95% CI −4.73 to 0.36; p=0.02). The intervention group was more positive than the control group on all the self-reported benefits ratings. Effect sizes (Cohen's d) ranged from 1.34 for feeling that dignity therapy had helped to 0.31 for increasing will to live.
Conclusions The effects of dignity therapy on people with advanced cancer are encouraging. Further investigation is warranted focusing on distressed patients and those earlier in the palliative care trajectory.
Trial register number ISRCTN29868352.
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Introduction
WHO1 and the Institute of Medicine2 emphasise the importance of holistic approaches to end of life care, which include the need to address the psychological and spiritual needs of patients. Although there has been considerable progress in treating the somatic symptoms of patients with advanced cancer, less is known about dealing with psychosocial, existential and spiritual issues. Loss of dignity for people with advanced cancer is associated with high levels of psychological and spiritual distress and loss of the will to live.3
Dignity therapy is an empirically-based individualised psychotherapy developed to increase the sense of purpose, meaning and worth, and reduce spiritual and psychological suffering for people with terminal illnesses.4 The therapy is based on a model of dignity developed from interviews with people with advanced cancer.5 The therapy comprises an interview with a therapist, in which individuals are offered the opportunity to address aspects of life they consider most important, such as recounting parts of their life they are proudest of, things they feel are, or were, most meaningful, the personal history they would most want remembered, or advice to their family and friends. These interviews are tape recorded, transcribed and edited to form a ‘generativity’ document, which is returned to the patient to share with people of their choosing. An important feature of the therapy is that it also has the potential to help close friends and relatives.6 Dignity therapy is brief, and can be delivered at the bedside by trained healthcare professionals. It has been hailed for its simplicity, and for its potential for helping people who are very close to the end of life and their families in their bereavement.7
A preliminary evaluation of dignity therapy conducted with 100 patients with advanced cancer in Canada and Australia produced positive findings for patients4 and their families.6 Most (91%) participants reported being satisfied with the therapy: 76% reported a heightened sense of dignity, 68% reported an increased sense of purpose, 67% reported a heightened sense of meaning, 47% reported an increased will to live and 81% reported that it had been, or would be, of help to their family. A recently published randomised controlled trial (RCT) of dignity therapy conducted in Canada, USA and Australia reported no differences between groups on primary outcomes (distress and quality of life) on completion of the intervention.8 However, the authors reported group differences on secondary outcomes, that is, self-reported end of life experiences, including finding dignity therapy helpful, increased sense of dignity, improved quality of life and being helpful to their family. Since responses to dignity therapy may be influenced by a range of important social and cultural factors, including access to palliative care services, the results may not be generalisable to the UK, where there are different structures of palliative care and other community services.
The aim of this phase II RCT is to assess the acceptability and potential effectiveness of dignity therapy to reduce distress in people with advanced cancer who have been referred to hospital-based palliative care teams in the UK.
Methods
Study design
This was a phase II open-label RCT.
Setting and participants
Between April 2009 and June 2010, we recruited 45 patients with advanced cancer aged 18 years or more, who had been referred to hospital-based palliative care teams working in two National Health Service trusts. We excluded patients if the palliative care team felt they were unable to take part in a protocol lasting 2 weeks (the time taken to collect baseline measures and complete the intervention), they were unable to provide informed consent (due to cognitive problems or the severity of their illness) or they were unable to understand English. We excluded patients with moderate or severe cognitive impairment as their ‘generativity’ documents were likely to reflect a distorted image of self, which could be distressing to them and recipients of these documents.
The intervention
The intervention group received dignity therapy, as described in box 1, in addition to standard palliative care. The intervention was delivered by DO, PM, CG or IJH, all of whom had been trained by Professor Harvey Max Chochinov (who developed the therapy). Training included the theoretical basis for the intervention, demonstrations of dignity therapy, a detailed overview of the therapy manual, editing the therapy documents and working with patients to produce a document that would be helpful for them and its recipients. We randomly selected one in three therapy transcripts to assess adherence to the dignity therapy protocol. There were no major deviations from the protocol and all therapies were completed. Further details of our recruitment procedure are given in our protocol.9
Box 1 The dignity therapy intervention
The interview
The therapist conducts an interview with participants, in which they are offered the opportunity to address aspects of life they consider most important, such as recounting parts of their life they are proudest of, things they feel are or were most meaningful, the personal history they would most want remembered, or advice to their family and friends. A standard framework of questions is used. These are given to patients following randomisation to give them the opportunity to think about their responses before the session. The question framework provides a flexible guide for the therapist to shape the interview, based on patients' level of interest and responses. The therapist follows the patients' cues, helping them to structure and organise their thoughts, for example, by asking questions about time sequences, how events are causally related to each other and facilitating the disclosure of thoughts, feelings and memories. If a patient prefers a friend or relative to be present during the dignity therapy session, they can either listen or join in. Patients sometimes find they need help to recall details. This strategy has proved to be very helpful for some patients in the piloting of dignity therapy in Canada, Australia and USA. The role of the person sitting in was agreed with the patient beforehand, and the therapist ensured that the discussion was led by the patients rather than their friends or relatives. Interviews usually last between 30 and 60 min. They are tape recorded and quickly transcribed verbatim.
Editing
The transcripts are shaped into a narrative using a formatted editing process. This includes clarifications to eliminate colloquialisms, non-starters and irrelevant sections (such as interruptions), chronological corrections, tagging and editing any content that might inflict significant harm on recipients of the document (after discussion with the patient) and finding a suitable ending for the document which is appropriate to the patient's overall message.
Agreeing the document
Another session is arranged for the therapist to read the edited transcript to the participants, who are invited to make editorial suggestions, including identifying errors of omission or commission. Once these ‘generativity’ documents are finalised, they become the property of the patient, who can share it with anyone they choose, whenever they choose. We gave them as many copies as they wished. At the start of the therapy, we asked patients who they intended to leave the ‘generativity’ document to, as this enables the therapist to guide the patient to cover the areas most relevant to the intended recipient(s). However, patients could change their mind about this at any time. They could decide not to give their ‘generativity’ document to anyone, or give it to other recipients. We did not exclude patients who do not wish to pass on their document. If they do not wish to bequeath it to anyone they can either destroy it or leave it with their other personal documents such as their will, diaries and important letters.
Standard care comprised assessment by a multi-professional palliative care team, including nurses, a psychosocial worker and doctors trained in providing psychosocial and spiritual support.
Control group
The control group received standard palliative care.
Sample size
For this phase II trial, we did not plan to detect significant group differences. One of the aims of the study was to estimate the effect size for a definitive RCT.
Randomisation and masking
We randomly allocated participants to either an intervention (dignity therapy offered in addition to standard care) or a standard care control group. Randomisation was conducted by an independent statistician using computer generated random numbers. Treatment allocation was performed by block randomisation with a fixed block size of two. We randomised participants after we had collected baseline measures, using sequentially numbered opaque sealed envelopes for consecutive participants to conceal allocation at recruitment. Researchers allocated patients to groups by opening the next envelope in the sequence.
Recruitment
The palliative care teams were informed of the study. Researchers regularly attended multidisciplinary team meetings to identify eligible patients. Both outpatients and inpatients were recruited. Clinicians gave eligible outpatients information about the study, and if they expressed an interest in taking part, gave the patient's contact details to the researcher. They introduced eligible inpatients to the researcher on ward rounds. These patients were given information about the study by the researcher. All patients were given at least 24 h to read the information sheet and, if they wished to, to discuss the study with family and friends. The researcher checked that patients understood their participation in the study, answered any questions and then obtained written consent to take part. Either CG, PM, DO or a research nurse enrolled and consented participants and allocated them to groups.
Outcome measures
We collected outcomes from patients in face-to-face interviews at enrolment (baseline) and approximately 1 and 4 weeks after completion of the intervention (when ‘generativity’ documents had been given to participants), and the equivalent in the control group. Interviews were conducted in patients' homes. The primary outcome was dignity-related distress (potential effectiveness), assessed using the Patient Dignity Inventory.10 Secondary outcomes were hope (Herth Hope Index),11 psychological distress (Hospital Anxiety and Depression Scale),12 quality of life (EQ-5D)13 and two 10-point Likert scales assessing current quality of life and satisfaction with quality of life,14 and palliative care outcomes.15 We also asked participants to rate the self-reported benefits of dignity therapy or taking part in the study (control group) (see table 1). Response options ranged from 1: strongly disagree to 5: strongly agree. These questions are similar to those used in a pilot study of dignity therapy for people with advanced cancer4 and the recently published RCT of dignity therapy for hospice patients.8
Self-reported benefits of dignity therapy and taking part in the study
Participant characteristics
We assessed cognitive functioning with the Blessed Orientation Memory Concentration Test,16 performance status with Karnosfsky scores17 and ability to perform activities of daily living with Barthel scores.18
Main statistical analyses
We used analysis of variance to compare the intervention and control group on dignity-related distress, hopefulness, psychological distress, quality of life and palliative outcomes. Baseline levels were entered as covariates. We calculated effect size estimates, that is, partial η2, which describes the ratio of variance explained in the dependent variable by a predictor while controlling for other predictors. We used independent t tests to compare the two groups on ratings of the self-reported benefits of the therapy or taking part in the study. We calculated effect size estimates, that is, Cohen's d, which describes the difference between two means divided by the SD.
Results
Study participants
The participants' characteristics are summarised in table 2. The flow of participants through the study is shown in figure 1.
Flow of participants through the study.
Characteristics of participants in the intervention and control groups
Of the 188 patients approached, 58 (31%) expressed an interest in being included in the study. Since 13 of these became too ill to take part in the baseline interview, 45/188 (24%) were randomised (22 intervention, 23 control). Group allocation was audited at the end of the study and there was no evidence that participants were not allocated in the correct sequence or to the correct groups. Five participants in the intervention group dropped out of the study without receiving the therapy (three became too ill and one decided that they didn't want the intervention). The reason for one person not receiving the intervention was not recorded. At 1-week follow-up, 29/45 (64%) participants remained in the study (15 control, 14 intervention), however, two of these completed self-reported benefits measures but not the primary outcome measure or any other measure of potential effectiveness. At the 4-week follow-up, 20/45 (44%) participants remained in the study (11 control, 9 intervention). One participant in each group completed the self-reported benefits but not the primary outcome measure or any other measure of potential effectiveness.
Baseline
At baseline, levels of distress and palliative-related concerns were relatively low and hopefulness and quality of life were relatively high. For example, mean scores for dignity-related distress were 46.13 and 43.00 for the control and intervention group, respectively. The scale range is 25 (no distress) to 125 (profound distress).
Primary outcome
Although there was a slight reduction in dignity-related distress in the control group at 1-week follow-up, the groups did not differ in dignity-related distress at any time point (table 3).
Comparisons of the intervention and control groups at baseline and follow-ups
Secondary outcomes
There was a reduction in hope in the control group at 1- and 4-week follow-up and a slight increase in hope in the intervention group (table 3). The intervention group showed higher levels of hope than the control group at both follow-ups. The effect sizes were medium and the difference was statistically significant at 1-week follow-up. The groups did not differ on measures of anxiety and depression, quality of life or palliative outcomes.
Acceptability: self-reported benefits
The intervention group was more positive than the control group on all the self-reported benefits ratings (table 1). Effect sizes were large for agreeing that dignity therapy had helped them, made their life more meaningful, and that it had, or would, help their families at both follow-ups, and for heightening their sense of purpose at 4-week follow-up. These differences were statistically significant for finding dignity therapy helpful at both follow-ups and for heightening their sense of purpose at 4-week follow-up.
Discussion
In this phase II trial, the groups did not differ on our primary outcome (dignity-related distress) or on four of our five secondary outcomes (assessing psychological distress, quality of life and palliative outcomes). Differences were small and inconsistent. There were, however, higher levels of hope and self-reported benefits in the intervention group compared to the control group at both follow-ups, suggesting that dignity therapy could help people with advanced cancer maintain hopefulness and enhance their end of life experiences. Hope is fundamental to life and, as a dimension of spirituality, is a particularly relevant concept in palliative and end of life care.19 For people with cancer, hopelessness is a predictor of thoughts of suicide20 and desire for hastened death.21 Hopefulness is also a way that terminally ill people may cope with their suffering and maintain a sense of meaning, purpose and self-worth.22 However, the methodological problems we experienced with the trial need to be considered: response rates were poor, attrition rates were high and baseline levels of distress were low.
There are three possible explanations for why we found no impact of dignity therapy on distress, quality of life or palliative-related outcomes. Firstly, there were ceiling and floor effects on measures of dignity-related distress, anxiety and depression, and palliative outcomes, leaving little room for improvement. We chose not to focus on distressed patients as it has been suggested that dignity therapy may be beneficial for patients reaching the end of life, whether overtly distressed or not.4 We also wished to compare our findings with a larger RCT of dignity therapy conducted with hospice patients.8 This trial, which did not screen potential participants for distress, also found low levels of distress at baseline and no group differences in distress or quality of life (hope was not assessed). In view of our relatively poor recruitment rate and high attrition rate, it is unlikely that we would have been able to complete the study with distressed patients referred to palliative care. Although we regularly attended palliative care team meetings to identify eligible patients, it took 14 months to recruit 45 patients. There is, however, a need to explore the impact of dignity therapy on distressed patients.
Secondly, the dignity-related distress, quality of life and palliative outcome measures may not be responsive to change. We chose the Palliative Dignity Inventory as our primary outcome because it was based on the same dignity model as dignity therapy.10 However, dignity-related distress, quality of life and palliative outcomes are multi-component constructs, which include physical symptoms and limitations on activities of daily living. Dignity therapy has not been developed to ameliorate such problems. In contrast, the Herth Hope Index11 focuses specifically on existential issues which are targeted by dignity therapy, such as recalling happy times and feeling that life has value and worth.
Thirdly, it is possible that the intervention is not effective and that the higher levels of hope in the intervention group were a chance finding. However, the intervention group outperformed the control group on all the self-reported benefits ratings. It is encouraging that they felt that the therapy had helped them, particularly increasing their sense of meaning and purpose, both of which are conceptually related to hope. The self-reported benefits ratings may reflect patients' perceptions of the effects of dignity therapy on the existential issues assessed in the Herth Hope Index (described above). Furthermore, they more directly reflect on the patients' experiences of receiving the therapy and taking part in the study. Participants also felt that dignity therapy had, or would, help their families. The potential benefit for dignity therapy to help families and friends in their time of bereavement is a unique aspect of dignity therapy. The comparisons of self-reported benefits involved asking patients who were not blinded to group allocation whether or not the dignity therapy or taking part in the study had helped them. It is possible that participants in the control group felt these questions were irrelevant, however, it is interesting that they perceived benefits from taking part in the study, which suggests that they were relevant and that research interviews could be beneficial to patients. We have explored the views of patients and their families on the therapy and on taking part in the study in qualitative interviews. Benefits reported by patients in the control group included feeling that somebody cared about them, having an opportunity to talk about their problems or feelings to a sympathetic and sensitive listener, and feeling that by taking part in the study they were making an important contribution to the research. The full results of the qualitative paper will be reported separately.
To the best of our knowledge, this is the first study to show that dignity therapy could increase hope in people with advanced cancer. The main strengths are the study design (RCT) and the inclusion of a longer-term (4-week) follow-up. One of the main limitations of this study is the small and relatively non-distressed sample. Although our initial sample was reasonable for a phase II study, less than half the sample completed the study. We focused on patients who had been referred to hospital-based palliative care teams. Referral to palliative care was often late in the disease trajectory, and the vast majority of patients were too ill to take part, deteriorated before they could be recruited, or were lost to follow-up. In addition to their often rapidly deteriorating physical condition, many patients were coming to terms with the move to palliative rather than curative treatment and their poor prognosis. Although dignity therapy has been developed specifically to help patients cope with the existential issues they are likely to be dealing with at this time, they may simply have felt too unwell to take part in research. Hence, dignity therapy may benefit patients who are somewhat earlier in their disease trajectory. However, the feasibility, acceptability and effectiveness of the intervention for such patients needs to be explored. A second limitation of this study is the use of opaque sequentially numbered envelopes carried by research assistants to determine group allocation, as this method is open to bias. A more rigorous method would be to use independent central allocation, for example, working with a clinical trials unit.
In conclusion, the mandate of palliative care is to address the physical, psychological and spiritual aspects of end of life experience. The effects of dignity therapy on people with advanced cancer specifically, and its possible influence on sense of meaning, purpose and hope are encouraging, however, our results are preliminary and do not themselves support the introduction of dignity therapy into clinical practice but do suggest that future research is warranted. The influence of dignity therapy on more overt distress will need to be determined in patient populations where baseline distress, such as depression and anxiety, is more pronounced. Future studies should include hope as an outcome, and include people somewhat earlier in their terminal disease trajectory in order to make dignity therapy available to populations still well enough to avail themselves of this novel psychotherapeutic approach.
Acknowledgments
The authors thank our funders, all the patients and the families who took part in the study, Professor Harvey Max Chochinov for providing training in dignity therapy and for his help in designing the study, Dr Gao Wei for conducting the randomisation, the palliative care teams who helped us contact patients, Rachael Dodd for her help with preparing the manuscript, and Caty Pannell for her help in recruiting and conducting follow-up interviews. The authors acknowledge the support of the National Institute for Health Research, through the National Cancer Research Network.
References
Footnotes
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Funding This research was supported by a grant from Dimbleby Cancer Care. They had no role in the study design; collection, analysis, or interpretation of the data; or writing of the report.
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Competing interests None.
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Ethics approval Ethics approval was obtained from King's College Hospital Research Ethics Committee (10/11/2008, ref: 08/H0808/155) and met the requirements of the local Research Governance Framework.
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Provenance and peer review Not commissioned; externally peer reviewed.