Cancer Support Programs
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Prostate Cancer |
Behavioral: Group Meetings Behavioral: Questionnaire |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Retrospective |
| Official Title: | Efficacy of Cancer Support Programs: A Social Comparison Theory Analysis |
- Patient Psychological Functioning and Quality of Life (QOL) [ Time Frame: Baseline and Month 3: Questionnaires & Support Group Assessments ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 240 |
| Study Start Date: | May 2009 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Homogeneous Support Group |
Behavioral: Group Meetings
10 weekly group meetings lasting 2 hours.
Behavioral: Questionnaire
Surveys
|
| Heterogeneous Support Group One |
Behavioral: Group Meetings
10 weekly group meetings lasting 2 hours.
Behavioral: Questionnaire
Surveys
|
| Heterogeneous Support Group Two |
Behavioral: Group Meetings
10 weekly group meetings lasting 2 hours.
Behavioral: Questionnaire
Surveys
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Participants, 21 years of age or older, diagnosed with Prostate Cancer or Breast Cancer.
Inclusion Criteria:
- Diagnosis of prostate or breast cancer, regardless of treatment
- No evidence of metastatic disease
- Able to read, speak, and write English
- Resides within one hour of M.D. Anderson Cancer Center
- 21 years of age or older
- Able to provide meaningful informed consent as judged by a research team member
- 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
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Cindy L Carmack Taylor, PHD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00798187 History of Changes |
| Other Study ID Numbers: | 2008-0594 |
| Study First Received: | November 24, 2008 |
| Last Updated: | February 26, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Prostate Cancer Breast Cancer Behavioral Intervention Cancer Support Programs |
Social Comparison Heterogeneous support group Homogeneous support group |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013