Dignity Therapy/Life Plan in Patients With Pancreatic or Advanced Lung Cancer

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT02132325
Collaborator
(none)
19
1
1
46.2
0.4

Study Details

Study Description

Brief Summary

This study will evaluate feasibility and acceptability of providing the Dignity Therapy/Life Plan intervention to pancreatic or advanced lung cancer patients presenting for treatment in the outpatient medical oncology setting. Investigators hypothesize that providing dignity therapy to this population will be feasible.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Dignity Therapy
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Phase I/IIA: Dignity Therapy/Life Plan in Patients With Pancreatic or Advanced Lung Cancer
Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
Feb 5, 2018
Actual Study Completion Date :
Feb 5, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dignity Therapy

Behavioral: Dignity Therapy
Dignity Therapy/Life Plan will be provided by an advanced practice nurse or chaplain (APN/Chap), who has undergone training in provision of Dignity Therapy (offered through a 3-day group workshop by Dr. Harvey Chochinov).

Outcome Measures

Primary Outcome Measures

  1. Change in level of distress as measured by distress scores on the Distress Thermometer [Baseline & at the end of the dignity therapy intervention (approximately 6 weeks)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age >18

  • Undergoing chemotherapy for pancreatic adenocarcinoma or advanced NSCLC (pancreatic arm closed)

  • English-speaking

  • Cognitively intact, per clinician judgment, as documented in electronic medical record (EMR)

Exclusion Criteria:
  • Currently receiving hospice or palliative care services

  • Concurrent diagnosis of delirium or dementia, per medical record

  • Diagnosis of major depression disorder, acute anxiety disorder or schizophrenia per medical record

  • Participating in other psychosocial intervention research studies.

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: Ann Marie Dose, PhD, RN, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ann (Ann Marie) M. Dose, R.N., Ph.D., Clinical Nurse Researcher, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02132325
Other Study ID Numbers:
  • 14-001857
First Posted:
May 7, 2014
Last Update Posted:
Mar 21, 2018
Last Verified:
Mar 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Ann (Ann Marie) M. Dose, R.N., Ph.D., Clinical Nurse Researcher, Mayo Clinic
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 21, 2018