Virtual Dignity Therapy for Cancer Palliative Care

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Schizophrenia, Bipolar, Recent hospitalization, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Virtual Dignity Therapy can be successfully offered to people with advanced cancer receiving palliative care. Virtual Dignity Therapy is a supportive treatment designed to help patients feel more at peace and valued. The trial seeks participants with advanced cancer who expect to live more than six months, are fluent in English, and can complete questionnaires. As an unphased trial, this study provides a unique opportunity to contribute to innovative supportive care research.

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that Virtual Dignity Therapy is safe for palliative care patients with advanced cancer?

Research shows that Virtual Dignity Therapy is generally easy for patients to handle. This therapy helps people in palliative care by reducing emotional distress and restoring a sense of dignity. Studies have found that patients consider the therapy practical and acceptable, and it enhances the feeling of dignity for those with advanced cancer.

No serious side effects have been linked to Virtual Dignity Therapy, indicating it is a safe option for those in palliative care. The therapy aims to relieve emotional suffering without causing physical side effects, making it a gentle and supportive treatment choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Virtual Dignity Therapy for cancer palliative care because it offers a novel approach to addressing the emotional and psychological needs of patients. Unlike standard palliative care, which often focuses on physical symptom management, this therapy emphasizes enhancing a patient's sense of meaning and purpose. The virtual aspect makes it accessible and convenient, allowing patients to engage in therapy from anywhere, which is particularly beneficial for those with mobility issues or living in remote areas. This innovative approach could significantly improve quality of life for patients by providing personalized emotional support.

What evidence suggests that Virtual Dignity Therapy is effective for cancer palliative care?

Research has shown that Virtual Dignity Therapy, which participants in this trial will receive, holds promise for patients in palliative care with advanced cancer. Studies have found that this therapy can reduce emotional suffering and distress related to a loss of dignity. Early results suggest it may enhance patients' sense of dignity and overall well-being. Patients generally find the therapy practical and acceptable, meaning it is manageable and beneficial. This approach aims to ease emotional and existential distress, potentially making the cancer journey more bearable. ^{1 2 4 5 6}

Who Is on the Research Team?

Deirdre Pachman, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 with advanced cancer and an expected prognosis of more than 6 months. They must be able to give informed consent and complete questionnaires, without diagnosed dementia or severe psychiatric conditions like recent hospitalization for mental illness.

Inclusion Criteria

Ability to complete questionnaire(s) by themselves or with assistance

My cancer has spread beyond its original location.

English fluency

Exclusion Criteria

Recent suicide attempt or psychiatric illness severe enough that hospitalization has been necessary in last 6 months

Active delirium

Other psychological co-morbidities such as untreated schizophrenia, bipolar disease

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Virtual Dignity Therapy, consisting of 3 sessions, each 2-4 weeks apart, focusing on life review and creating a generativity document

6-12 weeks

3 sessions (virtual)

Follow-up

Participants are monitored for acceptability and feasibility of the intervention

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Dignity Therapy

Trial Overview

The study is testing the feasibility and acceptability of a Virtual Dignity Therapy intervention designed for palliative care patients with advanced cancer to see if it can be successfully recruited for and delivered in this setting.

How Is the Trial Designed?

Group I: Virtual Dignity Therapy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

The FLOW-VRT-Relaxation therapy, a personalized virtual reality intervention, showed promising results in improving both physical and psychological symptoms in a 51-year-old patient with advanced cervix cancer, addressing her unmet needs for relaxation and emotional support.

This case study suggests that FLOW-VRT-Relaxation is a feasible and cost-effective method for enhancing end-of-life care, potentially reducing feelings of loneliness and increasing overall peace for patients in palliative settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case report: Therapeutic potential of Flourishing-Life-Of-Wish Virtual Reality Therapy on Relaxation (FLOW-VRT-Relaxation)-a novel personalized relaxation in palliative care. Woo, OKL., Lee, AM.[2023]

A new questionnaire was developed to identify patient goals and priorities for rehabilitation in palliative care, tested with 40 patients initially and 32 in a follow-up, showing good reliability in measuring the importance of various rehabilitation interventions.

The highest importance ratings were for physical, institutional, and self-care domains, indicating that patients prioritize these areas in their rehabilitation, which can help shape future palliative care services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care rehabilitation survey: a pilot study of patients' priorities for rehabilitation goals. Schleinich, MA., Warren, S., Nekolaichuk, C., et al.[2015]

The Palli-MONITOR study identified significant challenges in developing electronic patient-reported outcome measures for palliative home care, particularly due to patients' deteriorating health and the emotional burden of reflecting on their situation.

Involving stakeholders, including patients and professionals, is crucial for creating effective digital health tools, as their insights can help address both individual and organizational challenges in implementing these measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges developing an electronic patient-reported outcome measurement for palliative home care: A qualitative interview and focus group study. Burner-Fritsch, I., Bolzani, A., Hriskova, K., et al.[2023]

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]

The review identified 24 studies on electronic patient-reported outcomes (ePROs) in palliative cancer care, revealing that ePROs are primarily used for assessing study endpoints rather than as integral components of interventions.

There is a notable lack of innovative technology, such as smart activity trackers, in the literature, indicating opportunities for further research and development in patient-centered digital health interventions for palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic Patient-Reported Outcome-Based Interventions for Palliative Cancer Care: A Systematic and Mapping Review. Karamanidou, C., Natsiavas, P., Koumakis, L., et al.[2022]

Dignity therapy (DT) significantly improved generativity and ego-integrity scores in 56 adults with advanced terminal disease compared to life review (LR) and waitlist control (WC) groups, indicating its effectiveness in enhancing a sense of meaning and acceptance at the end of life.

Both DT and LR were highly accepted and satisfied by participants and their families, suggesting that these interventions are valuable in palliative care settings, although DT did not show significant changes in dignity-related distress or overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dignity Therapy and Life Review for Palliative Care Patients: A Randomized Controlled Trial. Vuksanovic, D., Green, HJ., Dyck, M., et al.[2022]

Health professionals have varying attitudes towards adapting the palliative care outcome scale (POS) for use on hand-held computers, indicating a need for further exploration of their views.

The study highlights specific challenges in integrating computerized clinical outcome measures in palliative care, emphasizing the importance of understanding these issues to improve patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the potential for the use of clinical outcome measures to be computerised? Findings from a qualitative research study. Hughes, RA., Sinha, A., Aspinal, F., et al.[2019]

Dignity therapy (DT) significantly reduced symptoms of depression in terminally ill patients at days 4 and 15, indicating its short-term efficacy in improving mental health during palliative care.

DT also led to significant decreases in anxiety symptoms at all follow-up points, suggesting it may be a valuable therapeutic option for managing distress in patients with life-limiting illnesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of dignity therapy for depression and anxiety in terminally ill patients: early results of a randomized controlled trial. Julião, M., Barbosa, A., Oliveira, F., et al.[2014]

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 (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]

In a randomized control trial involving 144 advanced cancer patients, dignity therapy did not show a statistically significant improvement in overall quality of life compared to usual care, with a change in mean symptom distress scores of 1.44 (p=0.670).

However, dignity therapy demonstrated a trend towards reducing anxiety levels (p=0.059) and showed improvements in appetite and overall well-being, suggesting potential benefits in specific areas of patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized control trial of advanced cancer patients at a private hospital in Kenya and the impact of dignity therapy on quality of life. Weru, J., Gatehi, M., Musibi, A.[2021]

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]

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