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: Unknown

21 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine if it is feasible and acceptable to recruit for and deliver the Virtual Dignity Therapy intervention to palliative care patients with advanced cancer.

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 data supports the idea that Virtual Dignity Therapy for Cancer Palliative Care is an effective treatment?

The available research does not provide specific data on the effectiveness of Virtual Dignity Therapy for Cancer Palliative Care. However, it does mention other digital interventions like electronic patient-reported outcomes and virtual reality therapy, which have shown potential in improving palliative care. For example, a case study on a virtual reality therapy called FLOW-VRT-Relaxation showed improvements in physical and psychological symptoms for a patient with advanced cancer. This suggests that digital therapies can be beneficial in palliative care, but more research is needed specifically on Virtual Dignity Therapy. ^{1 2 3 4 5}

What safety data exists for Virtual Dignity Therapy in cancer palliative care?

The available studies on Dignity Therapy, including its virtual and online versions, focus primarily on feasibility, acceptability, and efficacy rather than explicit safety data. These studies indicate that Dignity Therapy is feasible and acceptable for patients with terminal illnesses, showing benefits in reducing distress and improving quality of life. However, specific safety data, such as adverse effects or risks, are not detailed in the provided research abstracts. ^{6 7 8 9 10}

Is Virtual Dignity Therapy a promising treatment for cancer palliative care?

Yes, Virtual Dignity Therapy is a promising treatment for cancer palliative care. It helps reduce distress and improve the quality of life for people with terminal illnesses and their families. It is also more accessible and cost-effective when delivered online, making it easier for more people to benefit from it. ^{6 7 9 11 12}

Research Team

Deirdre Pachman, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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) 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 (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]

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]

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]

References

1. Switzerland 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Electronic Patient-Reported Outcome-Based Interventions for Palliative Cancer Care: A Systematic and Mapping Review. [2022]

3. England 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. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Palliative care rehabilitation survey: a pilot study of patients' priorities for rehabilitation goals. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Challenges developing an electronic patient-reported outcome measurement for palliative home care: A qualitative interview and focus group study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Dignity therapy online: Piloting an online psychosocial intervention for people with terminal illness. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy of dignity therapy for depression and anxiety in terminally ill patients: early results of a randomized controlled trial. [2014]

8. England pubmed.ncbi.nlm.nih.gov

Effect of dignity therapy on end-of-life psychological distress in terminally ill Portuguese patients: A randomized controlled trial. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. United States pubmed.ncbi.nlm.nih.gov

Implementing Dignity Therapy Service into an Acute Cancer Care Setting - A Feasibility Study. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Dignity Therapy and Life Review for Palliative Care Patients: A Randomized Controlled Trial. [2022]

12. England 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. [2021]