Clinical trial NCT01074385: Dignity Therapy in mCRC to Increase Peaceful Awareness & Impact Goals of Care Decision-Making
Official title: Use of Dignity Therapy in Stage IV Colorectal Cancer Patients Receiving Chemotherapy to Increase Peaceful Awareness and Impact Goals of Care Decision-Making
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stage IV Colorectal Cancer
Keywords: Stage IV Colorectal Cancer
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Robert H. Lurie Cancer Center
First posted: 2010-02-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Impact of Dignity Therapy
timeFrame: at baseline, 1-2 weeks after completion of dignity therapy sessions, 1 month after completion of sessions
Secondary outcomes:
measure: Measure the impact of dignity therapy on life sustaining therapy and end-of-life goals of care.
timeFrame: at baseline, 1-2 weeks after completion of dignity therapy sessions, 1 month after completion of dignity therapy sessions
measure: 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.
timeFrame: At Study Completion
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University, Northwestern Memorial Faculty Foundation
state: Illinois
Study officials:
affiliation: Northwestern University
name: Linda Emanuel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: