Dignity Therapy/Life Plan in Patients With Pancreatic or... | NCT02132325

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

NCT02132325

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Mar 21, 2018Actual

Enrollment

19Actual

Phase

Not Applicable

Conditions

Pancreatic Cancer
Non-Small-Cell Lung Cancer

Interventions

Dignity Therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Feb 5, 2018Actual

Completion Date

Feb 5, 2018Actual

First Submitted Date

May 1, 2014

First Submission Date that Met QC Criteria

May 5, 2014

First Posted Date

May 7, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2018

Last Update Posted Date

Mar 21, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dignity Therapy	Experimental		Behavioral: Dignity Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dignity Therapy	Behavioral	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).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ann Marie Dose, PhD, RN	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Rochester	Minnesota	55905	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000096225	Dignity Therapy

Ancestor Terms

ID	Term
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided