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

• ClinicalTrials.gov Identifier: NCT01074385
• Recruitment Status: Completed
• First Posted: February 24, 2010
• Last Update Posted: September 16, 2013
• Sponsor: Northwestern University
• Collaborator: Robert H. Lurie Cancer Center
• Information provided by (Responsible Party): Northwestern University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stage IV Colorectal Cancer	Behavioral: Dignity Therapy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• 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 Start Date: April 2010
• Actual Primary Completion Date: May 2012
• Actual Study Completion Date: October 2012

Arms and Interventions

Arm	Intervention/treatment
Immediate Dignity Therapy; 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.	Behavioral: Dignity Therapy; Dignity therapy is a psychotherapeutic intervention developed to address psychosocial and existential distress among terminally ill patients. Basically, it invites patients to discuss topics that matter most or how they want to be remembered. This interview is recorded and then edited and returned to the patient to be used for further reflection or for sharing with loved ones.
Wait List Dignity Therapy; 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.	Behavioral: Dignity Therapy; Dignity therapy is a psychotherapeutic intervention developed to address psychosocial and existential distress among terminally ill patients. Basically, it invites patients to discuss topics that matter most or how they want to be remembered. This interview is recorded and then edited and returned to the patient to be used for further reflection or for sharing with loved ones.

Outcome Measures

Primary Outcome Measures :

1. Impact of Dignity Therapy [ Time Frame: 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 :

1. Measure the impact of dignity therapy on life sustaining therapy and end-of-life goals of care. [ Time Frame: 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.
2. 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. [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Illinois

Northwestern University, Northwestern Memorial Faculty Foundation

Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Robert H. Lurie Cancer Center

Investigators

• Principal Investigator: Linda Emanuel, MD, PhD; Northwestern University

More Information

• Responsible Party: Northwestern University
• ClinicalTrials.gov Identifier: NCT01074385
• Other Study ID Numbers: NU 09CC3; STU00022908 ( Other Identifier: Northwestern University IRB ); NCI-2010-01851 ( Other Identifier: NCI CTRP# )
• First Posted: February 24, 2010
• Last Update Posted: September 16, 2013
• Last Verified: September 2013

Keywords provided by Northwestern University:

Stage IV Colorectal Cancer

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases