This study represents the first randomized control trial of Dignity Therapy. We set out to determine if this novel psychotherapeutic approach would significantly outperform standard care, or Client Centered Care (which focused on non-generativity, here and now issues) on various measures of psychological, existential and spiritual distress. While floor effects precluded our ability to demonstrate significant differences across study arms, our secondary outcomes revealed substantive benefits of Dignity Therapy. Using a post-study survey, patients who received Dignity Therapy were significantly more likely to report benefits, in terms of finding it helpful, improving their quality of life, their sense of dignity; changing how their family might see or appreciate them, and deeming it helpful to their family, compared to the other study arms.
Comprehensive palliative care requires that careful attention be paid to the physical, psychosocial, existential and spiritual sources of end-of-life distress. Restricting ones' focus on any of these domains to the exclusion of others, fails to meet standards of palliative care as specified by the World Health Organization17
and the Institutes of Medicine (IOM).18
In describing factors associated with a good death, the IOM includes preparation for death and opportunities for closure or `sense of completion' of the life.18
Yet, while significant inroads have been made in our ability to achieve physical comfort for dying patients, there are few novel interventions designed to address the psychosocial, existential and spiritual dimensions of end-of-life care.
Dignity Therapy was developed for the purpose of lessening distress and enhancing end-of-life experience for patients approaching death. In our phase I trial, nearly all patients found Dignity Therapy helpful, whether they had disclosed substantial initial distress or not.4
On the basis of that finding, baseline distress was not specified as an entry criteria for this current randomized controlled trial. Given that base rates of distress within our sample were quite low, it is perhaps not surprising that we were unable to measure any significant changes in distress across the three study arms. Showing improvement of measures of depression, will to live and quality of life, presupposes that patients' experience those areas as initially being problematic. In the absence of such initial distress, there is simply little room for improvement.
It is also possible that the instruments we used for our primary outcomes were less responsive and less sensitive to changes than the secondary outcome measures, whereby patients reported their experiences in a post-study survey. The difficulty of demonstrating psychosocial change at end of life by way of using self-report measures has been well documented. Unlike a chemotherapy trial, where survival interval, tumor load, and overall mortality provide readily measurable and objective outcomes, defining outcomes for Dignity Therapy is far more challenging. Dignity Therapy was designed to favorably influence the experience of people moving towards death. As such, measures of overt distress, along with indicators of psychosocial, existential and spiritual impact, were incorporated into the study protocol. A recent review of quality of life measures suitable for use in palliative care was unable to identify any with established responsiveness to change.19
A recent meta-analysis concluded that pre-intervention distress is a critical moderator of efficacy for psychosocial interventions for cancer patients.20
Scott et al have suggested that a more successful approach may be applying serial qualitative interviews.21
This approach, however, would not be well suited to a design comprised of an RCT.
Given the lack of significant difference across study arms for the primary outcome measures, we also considered whether the trial might have been underpowered. Our post-hoc power calculation, based on the actual number of trial participants determined that with 326 patients, this study had a power of 0.72 – 0.95 to detect an effect size of 0.15 – 0.30, respectively. It is also noteworthy that most non-significant differences had large p-values and significant differences had very small p-values, so the issue of power may be moot.
That said, patients receiving Dignity Therapy were significantly more likely than those assigned to other study arms, to report that this approach was helpful, that it improved their quality of life, enhanced their sense of dignity and provided benefits to their family. It would appear that although they reported their initial state of psychosocial or existential well-being as satisfactory, patients receiving Dignity Therapy often encountered an enhanced quality of end-of-life experience that they simply could not have anticipated. While difficult to measure, the impact was often poignant and profound. For instance, one 72-year-old woman with bowel cancer stated, “[Dignity therapy] brought to the forefront that I have to prepare my family to the best of my ability.” A 56-year-old woman said, “Mostly I want my family to know that I'm okay with dying and they must move on.” She went on to say that “the therapy showed me I am not the cancer, I am still in here. I am so grateful for that because I lost myself….it really helped me remember who I am.”
In hindsight, one might argue that this randomized controlled trial should have screened for patients reporting some baseline critical level of distress. That might have enhanced the likelihood of demonstrating differences across the three study arms, based on changes in the pre and post intervention questionnaires. Our disinclination to do so, however, was based on prior findings, illustrating the salutary effects of Dignity Therapy for nearly all patients nearing death, whether overtly distressed or not. Introducing critical thresholds of distress for study inclusion would have eliminated the vast majority of patients, who are most likely to partake of this novel therapeutic approach. Another consideration may have been a cross over design, in which patients could experience and thus compare Dignity therapy with other possible study conditions. However, given how ill these patients were, such a design would not have been feasible, with many patients either deteriorating or dying prior to a head to head comparison being possible.
It is also notable that of the 1513 patients who were accessed for eligibility, 42% were ineligible, primarily because they were too ill to take part in the study. Of those who met eligibility criteria, half consented to participate, nearly three-quarters of whom completed the protocol. For palliative care protocols that require cognitively intact participants, this recruitment pattern is not at all atypical.22
The nature of Dignity Therapy is such that only patients who are mentally capable of providing personally meaningful responses, are those who will be approached to take part. Therefore, generalizability should be framed in terms of those who maintain their cognitive capacity in proximity to death. Although this particular trial primarily involved patients with cancer, other studies have begun to explore its application in non-cancer populations23
We are not aware of any instance where patients withdrew from Dignity Therapy because of feeling upset or distressed. Many patients, however, indicated moments during Dignity Therapy that were emotionally evocative; for example, talking about hopes or wishes for family members in anticipation of a time beyond their death. By and large, however, patients appreciated the opportunity to articulate these issues. The only safety issue, which will be reported more fully in a separate paper describing family experiences of Dignity Therapy, concerned a few occasions where family members were dissatisfied with the generativity document. In those instances, they felt the patient had become too ill to give fulsome responses, or that the answers provided a distorted image of the participant. As such, it is important that patients who are delirious or otherwise cognitively impaired be excluded from Dignity Therapy.
Several studies have recently been published, reporting on the performance of Dignity therapy under various circumstances. A Phase I Danish study of ten health care professionals and twenty patients concluded that, with minor cultural adaptations, Dignity Therapy was “a manageable, acceptable and relevant intervention for Danish patients admitted to palliative care”.24
A pilot study of eight end stage patients in rural Kentucky with end stage cancer showed that Dignity Therapy could be delivered by videophone, and achieve overall benefit and high levels of patient satisfaction.25
A phase I study conducted in French Canada reported that amongst a cohort of 33 dying patients, relevance and satisfaction were found to be high, for patients and families alike.26
Despite the beneficial effects elicited by Dignity Therapy, its ability to mitigate outright distress, such as depression, desire for death or suicidality, remains unproven. Future research amongst more severely distressed patients may indeed establish its role in those particular circumstances. However, while “symptomatic relief of distress is an important goal of psychotherapeutic treatment, it is too limited a framework from which to consider the purpose and potential benefit of individual psychotherapy for patients with advanced or terminal disease.”27
In these circumstances, psychotherapy is not only offered to alleviate distress, but also as a means of preventing distress, promoting well being and establishing a sense of personal meaning and life purpose. Psychotherapeutic support can help patients face disappointments, process the reality of leaving behind loved ones; deal with feelings of sadness, loss, isolation and a damaged sense of identity and personal value. It can also help patients consider personal priorities regarding relationships, religious and spiritual beliefs, and deal with the urgency of resolving conflicts or achieve personally meaningful goals.27–30
Palliative care must offer patients opportunities to engage in this myriad of issues, and Dignity Therapy is one means by which it might do so. Future research exploring the salutary effects of Dignity Therapy will no doubt help to unravel the psychological, spiritual and existential complexities of facing death, and how to best support patients and families confronting advanced and terminal illness.
Research in Context
The systematic review that accompanied the application for funding of the Dignity Therapy RCT was incorporated into two publications; Chochinov HM, Hack T, Hassard T, et al. Dignity and Psychotherapeutic Considerations in End of Life Care. Journal of Palliative Care. 2004;20:142–143, and later updated, appearing in, Chochinov HM. Dying, Dignity and new Horizons in Palliative End-of-Life care. CA: A Cancer Journal for Clinicians. 2006;56(2):84–103. This is the first randomized trial of Dignity Therapy. Based on the findings of this study, clinicians should consider Dignity Therapy a viable therapeutic approach, which can enhance end-of-life experience for patients and families confronting death.