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

NCT01074385 | Completed

• 3 other identifiers: NU 09CC3STU00022908NCI-2010-01851
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage IV Colorectal Cancer

Keywords

Stage IV Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (2)

Immediate Dignity Therapy

OTHER

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

Wait List Dignity Therapy

OTHER

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

Interventions

Dignity Therapy BEHAVIORAL

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.

Immediate Dignity Therapy; Wait List Dignity Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern University: lead
• Robert H. Lurie Cancer Center: collaborator

Study Sites (1)

Northwestern University, Northwestern Memorial Faculty Foundation

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Dignity Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Linda Emanuel, MD, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: February 24, 2010
• Study Start: April 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: October 1, 2012
• Last Updated: September 16, 2013

Record last verified: 2013-09

Locations

US (1)