Expressive Disclosure and Colorectal Cancer

Colon and rectal cancer patients will be asked to participate in this study.

Part 1:

Participation in this study will include three tasks:

First, you will participate in individual interviews during which questions about quality of
life will be asked. You also will be provided information about a new expressive disclosure
group program for colon and rectal cancer patients, after which you will be asked your
opinions about the program. The entire individual interview will last 30 minutes to 1 hour.
The interviews will be audiotaped, and then the study staff will make a written copy of the
answers given on the tapes to be used in analysis.

Second, you will be asked to complete questionnaires about your medical history, quality of
life, mood, thought processes, coping style, and social support. It will take about 1 hour to
complete the questionnaires.

Third, you will be asked to wear an Electronically Activated Recorder (EAR) for two days in a
row. The EAR is a recording system consisting of a digital tape-recorder and a small external
microphone. The EAR is programmed to record for 30 seconds at a time, and then is off for 12
minutes. It repeats this 12.5 minute cycle the entire time while worn for two days. The
recordings from the EAR will provide information about your daily activities. The study staff
will make a written copy of what is said on the recordings for analysis. Before returning the
EAR device, you will be given the opportunity to schedule an appointment where you can listen
to the recordings and erase any portion that you think is embarrassing or private. If
participants have no concerns about the EAR recordings, the EAR can be returned in a prepaid
mailing packet. After wearing the EAR, you will complete an evaluation questionnaire over the
phone, which will take about 5 minutes.

This is an investigational study. A total of 25 colon and rectal cancer patients will be
asked to participate in this study. Participants will be from M.D. Anderson Cancer Center and
Kelsey-Seybold Clinics.

Part 2:

You will first be asked to complete a brief questionnaire about your mood. If the answers to
the questionnaire indicate that you are distressed, you will be eligible for the remainder of
the study. Only those participants who score as distressed will stay in the study. Regardless
of your answers, you will be informed of your test results and provided with a list of
community referrals. If your responses to the questionnaire indicate potential harm to
yourself, a licensed psychologist will follow-up with you and make recommendations, which may
include mental health referrals at M.D. Anderson and/or in the community.

If the first questionnaire indicates that you are distressed, you will be asked to complete
additional questionnaires about your medical history, quality of life, mood, thought
processes, coping style and social support. It will take about 1 hour to complete the
questionnaires.

You also will be asked to wear an Electronically Activated Recorder (EAR) for two days in a
row. The EAR is a recording system consisting of a digital tape-recorder and a small external
microphone. The EAR is programmed to record for 30 seconds at a time, and then is off for 12
minutes. It repeats this 12.5 minute cycle the entire time while worn for two days. The
recordings from the EAR will provide information about your daily activities. The study staff
will make a written copy of what is said on the recordings for analysis. Before returning the
EAR device, you will be given the opportunity to schedule an appointment where you can listen
to the recordings and erase any portion that you think is embarrassing or private. If
participants have no concerns about the EAR recordings, the EAR can be returned in a prepaid
mailing packet. After wearing the EAR, you will complete an evaluation questionnaire over the
phone, which will take about 5 minutes.

You will complete the questionnaires when you enter the study, 2 months after entering the
study, and 4 months after entering the study. You also will be asked to wear the EAR for 2
days when you enter the study, and for 2 days at 4 months after entering the study.

You will be assigned randomly (as in the toss of a coin) to one of two programs: the
Expressive Disclosure Group Program or the Standard Care Program.

Patients in the Expressive Disclosure Group Program will attend groups with about 11 members.
The program will include 12 group meetings over the course of 4months: 9 weekly meetings, 2
semi-monthly (twice a month) meetings, and a final meeting in month 4. Each meeting will last
1 hour. This program will involve talking and writing about several topics that are important
for individuals facing colon and rectal cancer. Participants in this program also will
receive written educational material and information about community resources. Group
meetings will be audio-taped. Copies of tapes will be provided to participants when they miss
a session. Tapes will sometimes be reviewed by project investigators to make sure the groups
are covering the program content.

Patients in the Standard Care Program will not attend any formal group meetings. They will
receive by mail written educational material and information about community resources.

This is an investigational study. A total of 149 individuals diagnosed with colon or rectal
cancer will take part in this study: 131 from M. D. Anderson and 18 from Kelsey-Seybold
Clinics.

Inclusion Criteria:

Part 1 - Descriptive Study:

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.

Part 2 - Pilot Randomized Trial:

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:

Part 1 - Descriptive Study:

1. Not being able to provide informed consent.

Part 2 - Pilot Randomized Trial:

1. Not being able to provide informed consent.