Dignity Therapy in mCRC to Increase Peaceful Awareness & Impact Goals of Care Decision-Making

Not Applicable

Completed

• Conditions: Stage IV Colorectal Cancer

• Registration Number: NCT01074385
• Lead Sponsor: Northwestern University

Brief Summary

The purpose of this study is to try and improve the way that patients with colon cancer understand and cope with their illness and give them tools for talking with their loved ones and family about their illness.

Detailed Description

Dignity Therapy is a well tolerated structured interview that helps patients reflect on who they are, what is most important to them and what lessons they have learned through life. For patients not receiving chemotherapy, Dignity Therapy gave patients more hope, more meaning in their life, and helped their families. Researchers at Northwestern University would like to see if it has the same effect in patients getting chemotherapy. We will also see if the Dignity Therapy changes patient's understanding of their disease and their medical preferences.

All study procedures will take place when participants come for a scheduled doctor's visit or to receive chemotherapy. At the first visit participants will answer a questionnaire taking approximately 15-30 minutes. Participants will then have a Dignity Therapy Session approximately 1-2 weeks later. A second Dignity Therapy Session will be scheduled again in another 1-2 weeks. Each study Dignity Therapy Session will take approximately an hour. One to two weeks later a repeat questionnaire will be filled out. Finally, a third and final questionnaire will be complete 4 weeks later.

Study Timeline

• Study First Submitted: 2010-02-22
• Study First Submitted QC: 2010-02-23
• Study First Posted: 2010-02-24
• Study Start: 2010-04
• Primary Completion: 2012-05
• Study Completion: 2012-10
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-13
• Last Update Posted: 2013-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Impact of Dignity Therapy	at baseline, 1-2 weeks after completion of dignity therapy sessions, 1 month after completion of sessions	Measure the impact of dignity therapy on terminal illness acknowledgment and presence of peaceful awareness. Subjects will complete self-evaluation questionnaires at the point of registration and upon completing dignity therapy sessions. The impact will be determined by changes in the patient's baseline self-reported parameters.

Secondary Outcome Measures

Name	Time	Method
Measure the impact of dignity therapy on life sustaining therapy and end-of-life goals of care.	at baseline, 1-2 weeks after completion of dignity therapy sessions, 1 month after completion of dignity therapy sessions	Subjects will complete self-evaluation questionnaires at the point of registration and upon completing dignity therapy sessions. The impact will be determined by changes in the patient's baseline self-reported parameters.
Establish a correlation between terminal illness acknowledgement and presence of peaceful awareness with preferences for life sustaining therapy and end-of-life goals of care.	At Study Completion	Establish a correlation between terminal illness acknowledgement and presence of peaceful awareness with preferences for life sustaining therapy and end-of-life goals of care.

Trial Locations

Locations (1)

Northwestern University, Northwestern Memorial Faculty Foundation; 🇺🇸 Chicago, Illinois, United States