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

March 19, 2018 updated by: Ann (Ann Marie) M. Dose, R.N., Ph.D., Mayo Clinic

Phase I/IIA: Dignity Therapy/Life Plan in Patients With Pancreatic or Advanced Lung Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in level of distress as measured by distress scores on the Distress Thermometer
Time Frame: Baseline & at the end of the dignity therapy intervention (approximately 6 weeks)
Baseline & at the end of the dignity therapy intervention (approximately 6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Ann Marie Dose, PhD, RN, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

February 5, 2018

Study Completion (Actual)

February 5, 2018

Study Registration Dates

First Submitted

May 1, 2014

First Submitted That Met QC Criteria

May 5, 2014

First Posted (Estimate)

May 7, 2014

Study Record Updates

Last Update Posted (Actual)

March 21, 2018

Last Update Submitted That Met QC Criteria

March 19, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-001857

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

A clean, deidentified data set will be made available to qualified requestors at study completion/dissemination.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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