Virtual Dignity Therapy for Palliative Care Patients With Advanced Cancer

Advanced Cancer Clinical Trial

Official title:

Feasibility and Acceptability of Virtual Dignity Therapy for Palliative Care Patients With Advanced Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05113199
• Other study ID #: 21-005065
• Status: Recruiting
• Phase: N/A
• Start date: November 18, 2021
• Est. completion date: October 31, 2025

Study information

• Verified date: February 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This study is an investigator-initiated, single site Mayo Clinic Rochester prospective minimal risk pilot study to determine feasibility and acceptability of Virtual Dignity Therapy. The Dignity Therapy intervention is a brief, individualized psychotherapy that aims to relieve psycho-emotional and existential distress and improve the experiences of patients whose lives are impacted by serious illness. This therapy offers patients an opportunity to reflect on their life with a trained facilitator and share their thoughts and memories with family and other people in their life. This therapy consists of a total of 3 sessions, with each session 2-4 weeks apart, in which the investigator provides questions focused on life review. The sessions are recorded and transcribed. The interventionist will work with patients to edit the document and provide a final generativity document for patient to keep and give to loved ones.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years

• English fluency

• No diagnosed dementia

• Diagnosis of advanced cancer

• Expected prognosis > 6 months

• Provide informed consent

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

Exclusion Criteria:

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

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

• Active delirium

• Participation in concurrent legacy offerings through the palliative care clinic

Inclusion Criteria for caregivers:

• Age =18 years

• English fluency

• Provide informed consent

• Supported patient through Dignity Therapy

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

Behavioral:
• Virtual Dignity Therapy
Virtual Dignity Therapy will be facilitated by a registered nurse or medical doctor trained in Dignity Therapy.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility Number	Study feasibility will be measured by the number of participants who enrolled and finished the study.	2 Years
Primary	Acceptability	Acceptability, as measured by the 7-item Was it Worth It (WIWI Questionnaire).The questions are answered as either "yes, no, or uncertain," overall perception of quality of life change, overall perception of study experience, one open-ended feedback question, and an option to talk with someone about concerns. Positive responses indicate acceptability. Results are reported as individual items.	Week 8 (after 3rd intervention session)