Dignity Therapy in mCRC to Increase Peaceful Awareness & Impact Goals of Care Decision-Making
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Purpose
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 | Intervention |
|---|---|
|
Stage IV Colorectal Cancer Dignity Therapy |
Behavioral: Dignity Therapy |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- Impact of Dignity Therapy [ Time Frame: at baseline, 1-2 weeks after completion of dignity therapy sessions, 1 month after completion of sessions ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 30 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
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.
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion 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.
Exclusion Criteria:
-
Contacts and Locations| United States, Illinois | |
| Northwestern University, Northwestern Memorial Faculty Foundation | |
| Chicago, Illinois, United States, 60611 | |
| Study Director: | Max Vergo, MD | Northwestern University |
More Information
No publications provided
| Responsible Party: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT01074385 History of Changes |
| Other Study ID Numbers: | NU 09CC3, STU00022908, NCI-2010-01851 |
| Study First Received: | February 22, 2010 |
| Last Updated: | April 1, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Northwestern University:
|
Stage IV Colorectal Cancer Dignity Therapy |
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 |
ClinicalTrials.gov processed this record on May 22, 2013