NCT02132325

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

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable pancreatic-cancer

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable pancreatic-cancer

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 1, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2018

Completed
Last Updated

March 21, 2018

Status Verified

March 1, 2018

Enrollment Period

3.9 years

First QC Date

May 1, 2014

Last Update Submit

March 19, 2018

Conditions

Keywords

Pancreatic CancerDignity TherapyPalliative CareAdvanced Lung CancerNon-Small-Cell Lung Cancer

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

EXPERIMENTAL
Behavioral: Dignity Therapy

Interventions

Dignity TherapyBEHAVIORAL

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).

Dignity Therapy

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Dignity Therapy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Ann Marie Dose, PhD, RN

    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
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.

Locations