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

Northwestern University

Status: Completed

Conditions: Stage IV Colorectal Cancer

Treatments: Behavioral: Dignity Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01074385

NCI-2010-01851 (Other Identifier)

STU00022908 (Other Identifier)

NU 09CC3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Participants must be currently receiving treatment for stage IV colorectal cancer.
• Participants must have experience disease progression after their first course of treatment and are being considered for second course of treatment or have already started their second course of treatment.
• Participants must be 18 years old or older.
• All participants must have given signed, informed consent prior to registration on study.
• Participants must speak English.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Immediate Dignity Therapy

Other group

Description:

At registration, subjects will be mailed a questionnaire. The subject will then receive two separate dignity therapy sessions, about a week apart. Subjects will then be asked to complete a questionnaire 1-2 weeks after completing therapy sessions and one month after completing therapy sessions.

Treatment:

Behavioral: Dignity Therapy

Wait List Dignity Therapy

Other group

Description:

At registration, subjects will be mailed a questionnaire. The subject will then receive two separate dignity therapy sessions; the first session will take place about 6 weeks after registration, with the second session occurring 1-3 weeks after the first. Subjects will then be asked to complete a questionnaire about one month after completing therapy sessions.

Treatment:

Behavioral: Dignity Therapy