Virtual Dignity Therapy for Palliative Care Patients With Advanced Cancer

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Cancer
• Intervention / Treatment: Behavioral: Virtual Dignity Therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Principal Investigator: Deirdre Pachman, MD
      • Contact: Melissa Felt; Phone Number: 507-255-4162; Email: Felt.Melissa@mayo.edu
      • Contact: Deirdre R. Pachman, MD; Phone Number: (507) 293-9791; Email: pachman.deirdre@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Dignity Therapy	Behavioral: Virtual Dignity Therapy; Virtual Dignity Therapy will be facilitated by a registered nurse or medical doctor trained in Dignity Therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility Number	Study feasibility will be measured by the number of participants who enrolled and finished the study.	2 Years
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)

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Deirdre Pachman, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2021
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: August 30, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Dignity Therapy
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 21-005065

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No