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

Stage IV Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01074385
• Other study ID #: NU 09CC3
• Secondary ID: STU00022908NCI-2
• Status: Completed
• Phase: N/A
• First received: February 22, 2010
• Last updated: September 13, 2013
• Start date: April 2010
• Est. completion date: October 2012

Study information

• Verified date: September 2013
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Stage IV Colorectal Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern University, Northwestern Memorial Faculty Foundation	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Robert H. Lurie Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No