MDACC Study Summary 2003-1028

Study Summary
No. 2003-1028:.......Colorectal......Cindy Carmack Taylor......Behavioral Science

Study Summary Title



Study Summary Number:	2003-1028

Study Title:	Expressive Disclosure Program for Colorectal CA Patients

Physician

New Patient Referral



Name:	Cindy Carmack Taylor	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Behavioral Science	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-3582 Contact us about clinical trials

General Information



Disease Group:	Colorectal	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Part 1: Participants come to MDACC for one assessment session. Part 2: Participants in the Expressive Disclosure Program come to MDACC for 3 assessment sessions and 12 group meetings; those in Standard Care come to MDACC for 3 assessment sessions.

Treatment Agents:	Psychosocial	Home Care:	N/A

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this psychosocial research study is to look at factors that may affect the quality of life of patients with colon and rectal cancer, by gathering information about them. This information will be used to develop a quality of life program for patients facing colon and rectal cancers.

Study Objectives / Outcomes

We propose 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, we 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 our assessment procedures including completing the written questionnaires and wearing the Electronically Activated Recorder (EAR). In Part 2, we will conduct 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.
The 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.

Study Status Information



Study Activation / Registration Date:	10/27/2005

IRB Review and Approval Date:	01/21/2004

Study Type:	Not Applicable

Recruitment Status:	Closed

Projected Accrual:	174

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Part 1 - Descriptive Study: Eligibility criteria include:1) having a diagnosis of stage I, II, or III colon or rectal cancer; 2) having completed treatment for colon or rectal cancer within the past year; 3) having the ability to read, speak and write English; 4) being a resident of the State of Texas; and 5) being 18 years old or older.

2) Part 2 - Pilot Randomized Trial: Eligibiity criteria include: 1) having a diagnosis of stage I, II, or III colon or rectal cancer; 2) having completed treatment for colon or rectal cancer; 3) 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; 4) having the ability to read, speak and write English; 5) residing within one hour of M.D. Anderson Cancer Center; and 6) being 18 years old or older.

Exclusion Criteria:

1) Part 1 - Descriptive Study: Exclusion - (1) Not being able to provide informed consent.

2) Part 2 - Pilot Randomized Trial: Exclusion - (1) Not being able to provide informed consent.

Links

Registration Number: NCT00853203
Study Information on Clinical Trials Registry (clinicaltrials.gov)