Expressive Disclosure and Colorectal Cancer
Status unconfirmed
Conditions studied: Colorectal Cancer
In brief
This is a Two-part Pilot Study: Part 1 is descriptive and Part 2 is a pilot randomized trial. Part 1 will be a formative study in which individual interviews are conducted with 20 patients previously diagnosed with colorectal cancer. During open-ended interviews, researchers will collect data on QOL issues colorectal cancer patients face and will elicit feedback regarding development of and participation in a pilot expressive disclosure intervention. Patients also will pilot test an assessment procedures including completing the written questionnaires and wearing the Electronically Activated Recorder (EAR). Part 2 will include a small randomized pilot test in which 44 patients (two cohorts of 22 patients) will be randomly assigned to the Expressive Disclosure Group Program or a Standard Care Control Group. Aims of the study include: * To conduct a descriptive study of colorectal cancer patients, through qualitative interviews and standardized questionnaires, in an effort to assess their QOL, specific health and emotional problems, issues related to social functioning, and preferences regarding intervention format and logistics. * To use the information from the descriptive study to develop an Expressive Disclosure Group Program for colorectal cancer patients. * To pilot test a novel technology called the Electronically Activated Recorder (EAR) for assessing cognitive processing and social support in colorectal cancer patients and compare these data to those obtained with traditional self-report measures. * To pilot test the Expressive Disclosure Group Program and conduct process evaluation including rates of recruitment and retention, attendance, satisfaction, barriers to participation, and feasibility of randomization. * To explore the effects of the Expressive Disclosure Group Program on outcome variables of QOL and psychological functioning and mediating variables of cognitive processing, coping skills, and social support.
Key facts
- Study ID
- NCT00853203
- Run by
- M.D. Anderson Cancer Center
- People needed
- 174
- Starts
- 2009-01-01
- Expected to finish
- 2021-08-01
- Last updated by the study team
- 2020-12-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Part 1 - Descriptive Study:
- having a diagnosis of stage I, II, or III colon or rectal cancer;
- having completed treatment for colon or rectal cancer within the past year;
- having the ability to read, speak and write English;
- being a resident of the State of Texas; and
- being 18 years old or older.
- Part 2 - Pilot Randomized Trial:
- having a diagnosis of stage I, II, or III colon or rectal cancer;
- having completed treatment for colon or rectal cancer;
- being a distressed patient: a T score >63 on the Global Severity Index (GSI) of the Brief Symptom Inventory (BSI) or a T score >63 on any two primary dimensions of this measure;
- having the ability to read, speak and write English;
- residing within one hour of M.D. Anderson Cancer Center; and
- being 18 years old or older.
You may not qualify if…
- Part 1 - Descriptive Study:
- Not being able to provide informed consent.
- Part 2 - Pilot Randomized Trial:
- Not being able to provide informed consent.
Where it is running
- Kelsey-Seybold Clinics — Houston, Texas, United States
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.