Dignity Therapy for End of Life Care

Not currently recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Delirium, altered mental status

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a therapy called dignity therapy for LGBTQ+ patients receiving end-of-life care. Dignity therapy involves a conversation where patients share their life stories to create a legacy document for their loved ones. The goal is to determine if this therapy is practical and beneficial for LGBTQ+ patients. Suitable participants include those who identify as LGBTQ+, have a solid tumor cancer diagnosis, receive palliative care at Memorial Sloan Kettering, and speak English well. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance end-of-life care for the LGBTQ+ community.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on therapy rather than medication, so you may not need to change your current meds.

What prior data suggests that dignity therapy is safe for SGM patients?

Research has shown that dignity therapy is generally well-received by patients. In one study, 91% of patients with terminal illnesses reported satisfaction with the therapy. Most patients felt more dignified and emotionally relieved. Specific safety information for dignity therapy is not available in the research articles. However, since this therapy involves conversation rather than drugs or physical procedures, it is less likely to cause physical harm compared to medical treatments. Overall, dignity therapy appears to be a safe option for those seeking emotional support at the end of life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Dignity Therapy is unique because it offers a personalized, human-centered approach to end-of-life care, focusing on creating a sense of meaning and legacy for patients. Unlike standard care options, which may primarily address physical symptoms, Dignity Therapy involves a virtual interview where patients share important life stories and reflections. This interview is recorded and transcribed, providing a tangible legacy document for both patients and their families. Researchers are excited about this therapy because it emphasizes emotional well-being and dignity, potentially improving the quality of life for patients in their final days.

What evidence suggests that dignity therapy is effective for end of life care?

Research has shown that dignity therapy, which participants in this trial will receive, can help people nearing the end of their lives. It reduces distress related to dignity and eases psychological suffering. Studies have found that it can boost hope and improve quality of life. In one study, staff members found it meaningful because it eased patients' pain and provided care. For family members, it has been important in reducing anxiety and depression. Overall, dignity therapy offers valuable support for those facing end-of-life challenges. ^{1 3 6 7 8}

Who Is on the Research Team?

William E Rosa, Ph.D., MBE, NP

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adult sexual and gender minority (SGM) patients, including LGBTQ+ individuals, who are in hospice care. They must be able to speak English and willing to participate in the therapy sessions in English. Patients with delirium or altered mental status that prevents them from giving consent cannot join.

Inclusion Criteria

SGM hospice patients identified through Metropolitan Jewish Health System (MJHS) Institute for Innovation in Palliative Care, New York

I speak English and am willing to receive treatment in English.

Exclusion Criteria

Delirium/altered mental status prohibitive of providing consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dignity Therapy Intervention

Participants undergo a 45-75 minute virtual dignity therapy session, which is recorded and transcribed

1 session

1 virtual visit

Follow-up

Participants are monitored for completion of the intervention and delivery of the poem

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Dignity Therapy

Trial Overview The study is testing dignity therapy—a type of psychotherapy designed for SGM hospice patients. It involves discussing their life stories to create a legacy document that can be shared with loved ones, aiming to see if it's practical and effective at end of life.

How Is the Trial Designed?

Group I: Dignity Therapy Experimental Treatment 1 Intervention

The DT intervention is a 45-75-minute virtual interview, which is recorded and transcribed within 1-2 weeks of the interview.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

The paper emphasizes the importance of developing robust serious adverse event (SAE) reporting procedures in non-pharmaceutical palliative care trials, as patients often face high risks of hospitalization or death due to their underlying conditions rather than the trial interventions.

Recommendations for improving SAE management include allowing sufficient planning time, defining what constitutes a serious adverse event for the specific study population, and refining reporting procedures throughout the trial to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What should we report? Lessons learnt from the development and implementation of serious adverse event reporting procedures in non-pharmacological trials in palliative care. Dunleavy, L., Collingridge Moore, D., Korfage, I., et al.[2021]

Dignity Therapy (DT) was successfully implemented in a cancer center, showing feasibility and acceptability among 10 patients with metastatic cancer, indicating it can be integrated into clinical practice.

The intervention demonstrated positive outcomes in reducing existential distress and improving health-related quality of life, suggesting it could be beneficial for patients nearing the end of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating dignity therapy into practice: effects and lessons learned. Johns, SA.[2017]

Dignity therapy, a short-term psychotherapy for end-of-life patients, significantly reduced distress levels in participants compared to a control group, indicating its effectiveness in enhancing patient well-being.

The feasibility of implementing dignity therapy in a hospital setting was supported, though it requires 5.5 to 11 hours of therapist time, highlighting the importance of team support and resources for successful delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Dignity Therapy Service into an Acute Cancer Care Setting - A Feasibility Study. Kelly, C., Kynoch, K., Ramis, MA.[2023]

The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) has been validated as a reliable tool for assessing symptoms and their impact on quality of life in patients undergoing phase I cancer trials, based on a study of 479 patients.

There were significant correlations between PRO-CTCAE items and measures of psychological distress and quality of life, particularly for mood-related items, indicating that PRO-CTCAE can effectively capture the patient experience in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Patient-Reported Outcomes to Describe the Patient Experience on Phase I Clinical Trials. Sedhom, R., Ferrell, B., Ruel, N., et al.[2022]

Dignity therapy (DT) significantly reduced demoralization syndrome (DS) from 60% in the control group to 12.1% in the DT group among 80 terminally ill patients, indicating its effectiveness in alleviating psychological distress.

DT also decreased the desire for death (DfD) prevalence from 14.3% in the control group to 0% in the DT group, and improved patients' sense of dignity, suggesting it is a valuable therapeutic approach for enhancing end-of-life care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of dignity therapy on end-of-life psychological distress in terminally ill Portuguese patients: A randomized controlled trial. Julião, M., Oliveira, F., Nunes, B., et al.[2018]

Dignity therapy delivered online is feasible and acceptable for terminally ill patients, showing similar levels of effectiveness to traditional face-to-face therapy while reducing therapist time by about 40%.

Participants found the online format convenient, and the use of email for therapy may further lower costs and improve access, highlighting the potential for wider implementation of dignity therapy in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dignity therapy online: Piloting an online psychosocial intervention for people with terminal illness. Bentley, B., O'Connor, M., Williams, A., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8205385/

Dignity Therapy for End-of-Life Care Patients: A Literature ... For family care members, dignity therapy was essential to decrease anxiety, depression, and burden associated with end-of-life care.

2. bmcpalliatcare.biomedcentral.com bmcpalliatcare.biomedcentral.com/articles/10.1186/s12904-025-01812-4

Use of dignity therapy in palliative care: a comprehensive ... These studies show that, although Dignity Therapy appears to be effective, its impact on several health measures has been limited in some cases— ...

3. kosinmedj.org kosinmedj.org/journal/view.php?number=1209

Dignity therapy for effective palliative care: a literature review According to 92% of the staff members at hospice care, it was considered meaningful because it relieved patients' pain and provided care to ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37980718/

Effectiveness of dignity therapy on well-being among ... Conclusions: Dignity therapy was effective in improving dignity-related distress, quality of life, and levels of hope. A meta-analysis found no significant ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S002074892300189X

Effectiveness of dignity therapy on well-being among ... Dignity therapy is relatively effective in reducing psychological suffering, improving a sense of dignity, and hope, and increasing the quality of life and ...

6. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.focus.11.4.576

Effect of Dignity Therapy on Distress and End-of-Life ... In a phase 1 trial with 100 terminally ill patients, 91% were satisfied with dignity therapy, and 76% reported a heightened sense of dignity, 68% an increased ...

7. withpower.com withpower.com/trial/phase-death-2024-f3a55

Dignity Therapy for End of Life Care · Info for Participants There is no specific safety data available for Dignity Therapy in the provided research articles. However, non-pharmaceutical trials in palliative care, like ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1462388911001268

Dignity conserving care at end-of-life: A narrative review This narrative literature review uses systematic principles to define evidence regarding dignity conserving care at end-of-life from published research on ...