Virtual Dignity Therapy for Palliative Care Patients With Advanced Cancer

• Sponsor: Mayo Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05113199
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 13.4
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Cancer	Behavioral: Virtual Dignity Therapy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Feasibility and Acceptability of Virtual Dignity Therapy for Palliative Care Patients With Advanced Cancer
• Actual Study Start Date: Nov 18, 2021
• Anticipated Primary Completion Date: Oct 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Feasibility Number [1 Year]

   Study feasibility will be measured by the number of participants who enrolled and finished the study.

2. Acceptability [Week 8 (after 3rd intervention session)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Deirdre Pachman, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Deirdre R. Pachman, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT05113199
• Other Study ID Numbers: 21-005065
• First Posted: Nov 9, 2021
• Last Update Posted: Jan 25, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Deirdre R. Pachman, Principal Investigator, Mayo Clinic: Dignity Therapy
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Jan 25, 2022