Dignity Therapy/Life Plan in Patients With Pancreatic or Advanced Lung Cancer
Phase I/IIA: Dignity Therapy/Life Plan in Patients With Pancreatic or Advanced Lung Cancer
1 other identifier
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable pancreatic-cancer
Started Apr 2014
Typical duration for not_applicable pancreatic-cancer
1 active site
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
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 1, 2014
CompletedFirst Posted
Study publicly available on registry
May 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 5, 2018
CompletedMarch 21, 2018
March 1, 2018
3.9 years
May 1, 2014
March 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (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)
Study Arms (1)
Dignity Therapy
EXPERIMENTALInterventions
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).
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ann Marie Dose, PhD, RN
Mayo Clinic
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
- Clinical Nurse Researcher
Study Record Dates
First Submitted
May 1, 2014
First Posted
May 7, 2014
Study Start
April 1, 2014
Primary Completion
February 5, 2018
Study Completion
February 5, 2018
Last Updated
March 21, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will share
A clean, deidentified data set will be made available to qualified requestors at study completion/dissemination.