Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments group meetings, questionnaire
Sponsor M.D. Anderson Cancer Center
Collaborator National Cancer Institute (NCI)
Start date May 2009
End date November 2017
Trial size 240 participants
Trial identifier NCT00798187, 1R21CA126854, 2008-0594

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective retrospective
Arm
group meetings
10 weekly group meetings lasting 2 hours.
questionnaire
Surveys
group meetings
10 weekly group meetings lasting 2 hours.
questionnaire
Surveys
group meetings
10 weekly group meetings lasting 2 hours.
questionnaire
Surveys

Primary Outcomes

Measure
Patient Psychological Functioning and Quality of Life (QOL)
time frame: Baseline and Month 3: Questionnaires & Support Group Assessments

Secondary Outcomes

Measure
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.
time frame: 2 Years

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title Efficacy of Cancer Support Programs: A Social Comparison Theory Analysis
Principal investigator Cindy L Carmack Taylor, PHD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.