NCT05113199

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 9, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

November 18, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2025

Completed
Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

3.3 years

First QC Date

August 30, 2021

Last Update Submit

February 27, 2025

Conditions

Keywords

Dignity Therapy

Outcome Measures

Primary Outcomes (2)

  • 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)

Study Arms (1)

Virtual Dignity Therapy

EXPERIMENTAL
Behavioral: Virtual Dignity Therapy

Interventions

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

Virtual Dignity Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Age ≥18 years
  • English fluency
  • Provide informed consent
  • Supported patient through Dignity Therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

Study Officials

  • Deirdre Pachman, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 30, 2021

First Posted

November 9, 2021

Study Start

November 18, 2021

Primary Completion

February 17, 2025

Study Completion

February 17, 2025

Last Updated

March 3, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations