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Efficacy of Cancer Support Programs: A Social Comparison Theory Analysis


N/A
21 Years
N/A
Open (Enrolling)
Both
Prostate Cancer

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Trial Information

Efficacy of Cancer Support Programs: A Social Comparison Theory Analysis


Screening Questionnaires:

Signing this consent form does not mean that you will be able to take part in this study.
You will complete some questions about your mood to help researchers decide if you are
eligible to take part in this study. It will take 10 to 15 minutes to complete these
questions.

The researcher will discuss the questionnaire results with you and provide you with a list
of community referrals and resources.

If your responses to the questions show that you are distressed, you will be eligible to
take part in this study. If your responses to the questions show that you are not
distressed, you will be randomly selected (as in the flip of a coin) to take part in this
study.

If your responses to the questions show that you may harm yourself, a licensed psychologist
will follow-up with you and make recommendations for future treatment.

Study Questionnaires:

If you are found to be eligible and are selected to take part in this study, you will be
asked to complete questionnaires that will have questions about your medical history,
quality of life, mood, thought processes, methods of coping with the disease, and support
that you receive from others. It will take about 1 hour to complete these questionnaires.

Support Groups:

You will also take part in a support group program for either prostate or breast cancer
patients. Each support group will be made up of about 10 members. Each group will meet 1
time each week for 10 weeks. Each meeting will last about 2 hours. At each meeting,
patients will discuss and learn about methods of coping with the disease and ways to relax.

All meetings will be audio-recorded. Recordings will be reviewed by the research team to
make sure that the groups are covering the program content.

Length of Study:

You will be on study for about 3 months.

End-of Study Questionnaires:

After the last support group meeting, you will complete questionnaires that will ask
questions about your medical history, quality of life, mood, thought processes, methods of
coping with the disease, and support that you receive from others. You will be off study
after you have completed the end-of-study questionnaires.

This is an investigational study.

Up to 240 patients will take part in this study. Up to 204 will be enrolled at MD Anderson.


Inclusion Criteria:



1. Diagnosis of prostate or breast cancer, regardless of treatment

2. No evidence of metastatic disease

3. Able to read, speak, and write English

4. Resides within one hour of M.D. Anderson Cancer Center

5. 21 years of age or older

6. Able to provide meaningful informed consent as judged by a research team member

7. Being a distressed patient: a T score greater than or equal to 63 on the Global
Severity Index (GSI) of the Brief Symptom Inventory (BSI) or a T score greater than
or equal to 63 on any two primary dimensions of this measure, or being a
non-distressed patient: a T score of < 63 on the GSI and a T score of <63 on all
primary dimensions of the BSI.

Exclusion Criteria:

1) None

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Retrospective

Outcome Measure:

Patient Psychological Functioning and Quality of Life (QOL)

Outcome Time Frame:

Baseline and Month 3: Questionnaires & Support Group Assessments

Safety Issue:

No

Principal Investigator

Cindy L Carmack Taylor, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2008-0594

NCT ID:

NCT00798187

Start Date:

May 2009

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Breast Cancer
  • Behavioral Intervention
  • Cancer Support Programs
  • Social Comparison
  • Heterogeneous support group
  • Homogeneous support group
  • Prostatic Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030