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Expressive Disclosure Program for Colorectal Cancer Patients


N/A
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

Thank you

Trial Information

Expressive Disclosure Program for Colorectal Cancer Patients


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

To collect information about factors affecting colon and rectal cancer patients' quality of life (QOL) in order to develop a QOL program.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Cindy C Taylor, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2003-1028

NCT ID:

NCT00853203

Start Date:

January 2009

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Colorectal Cancer
  • Rectal Cancer
  • Psychosocial
  • Expressive Disclosure
  • Questionnaires
  • Quality of life
  • QOL
  • Electronically Activated Recorder
  • EAR
  • Colorectal Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030
Kelsey-Seybold ClinicsHouston, Texas  77030