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

Use of Dignity Therapy in Stage IV Colorectal Cancer Patients Receiving Chemotherapy to Increase Peaceful Awareness and Impact Goals of Care Decision-Making

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.

Study Overview

• Status: Completed
• Conditions: Stage IV Colorectal Cancer
• Intervention / Treatment: Behavioral: Dignity Therapy

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University, Northwestern Memorial Faculty Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of Dignity Therapy	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.	at baseline, 1-2 weeks after completion of dignity therapy sessions, 1 month after completion of sessions

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure the impact of dignity therapy on life sustaining therapy and end-of-life goals of care.	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.	at baseline, 1-2 weeks after completion of dignity therapy sessions, 1 month after completion of dignity therapy sessions
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.	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

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Robert H. Lurie Cancer Center
• Investigators: Principal Investigator: Linda Emanuel, MD, PhD, Northwestern University

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ACTUAL): May 1, 2012
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: February 22, 2010
• First Submitted That Met QC Criteria: February 23, 2010
• First Posted (ESTIMATE): February 24, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): September 16, 2013
• Last Update Submitted That Met QC Criteria: September 13, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Stage IV Colorectal Cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: NU 09CC3; STU00022908 (OTHER: Northwestern University IRB); NCI-2010-01851 (OTHER: NCI CTRP#)