Expressive Disclosure and Colorectal Cancer

Summary

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.

Conditions

• Colorectal Cancer

Interventions

BEHAVIORAL

Interviews

Open-ended Interviews, audiotaped, lasting 30 minutes to 1 hour.

BEHAVIORAL

Questionnaires

Written survey taking about 1 hour.

OTHER

Electronically Activated Recorder (EAR)

Recording system (a digital tape-recorder and small external microphone) programmed to record for 30 seconds every 12 minutes, repeating over two consecutive days of wearing.

BEHAVIORAL

Group Meetings

12 Audiotaped Group Meetings over 4 months: 9 weekly meetings, 2 semi-monthly (twice a month) meetings, and a final meeting in month 4. Each meeting will last 1 hour.

BEHAVIORAL

Written Materials

Written educational materials plus community resource information.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Cindy L. Carmack Taylor, PHD · M.D. Anderson Cancer Center

• Karen Basen-Engquist, PHD, BA, MPH · M.D. Anderson Cancer Center

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-01-31

Primary Completion

2021-08-31

Completion

2021-08-31

Countries

• United States

Study Locations