Back to resultsDignity Therapy/Life Plan in Patients With Pancreatic or Advanced Lung Cancer
Primary Purpose
Pancreatic Cancer, Non-Small-Cell Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dignity Therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Pancreatic Cancer focused on measuring Pancreatic Cancer, Dignity Therapy, Palliative Care, Advanced Lung Cancer, Non-Small-Cell Lung Cancer
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dignity Therapy
Arm Description
Outcomes
Primary Outcome Measures
Change in level of distress as measured by distress scores on the Distress Thermometer
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02132325
Brief Title
Dignity Therapy/Life Plan in Patients With Pancreatic or Advanced Lung Cancer
Official Title
Phase I/IIA: Dignity Therapy/Life Plan in Patients With Pancreatic or Advanced Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
February 5, 2018 (Actual)
Study Completion Date
February 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Non-Small-Cell Lung Cancer
Keywords
Pancreatic Cancer, Dignity Therapy, Palliative Care, Advanced Lung Cancer, Non-Small-Cell Lung Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dignity Therapy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Dignity Therapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Marie Dose, PhD, RN
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
A clean, deidentified data set will be made available to qualified requestors at study completion/dissemination.
Learn more about this trial
Dignity Therapy/Life Plan in Patients With Pancreatic or Advanced Lung Cancer
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