Efficacy of Cancer Support Programs: A Social Comparison Theory Analysis

Prostate Cancer Clinical Trial

Official title:

Efficacy of Cancer Support Programs: A Social Comparison Theory Analysis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00798187
• Other study ID #: 2008-0594
• Secondary ID: 1R21CA126854
• Status: Terminated
• Start date: May 2009
• Est. completion date: March 26, 2019

Study information

• Verified date: May 2019
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this research study is to learn if a support group program is acceptable for patients with prostate cancer or patients with breast cancer. Researchers also want to learn if the characteristics of the members of the support group program can have an effect on the quality of life of other members of the support group program. Support group programs will be conducted separately for prostate cancer patients and breast cancer patients.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 240
• Est. completion date: March 26, 2019
• Est. primary completion date: March 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Group Meetings
10 weekly group meetings lasting 2 hours.
• Questionnaire
Surveys

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Psychological Functioning and Quality of Life (QOL)		Baseline and Month 3: Questionnaires & Support Group Assessments
Secondary	To study if the characteristics of the members of the support group program can have an effect on the quality of life of other members of the support group program.		2 Years

External Links

•   The University of Texas M.D.Anderson Cancer Center