Prostate Cancer Support Programs - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00798187

Purpose

Primary and Secondary Aims:

1a. To collect feasibility and process evaluation data, including rates of recruitment and retention, group attendance, satisfaction, barriers to participation, and feasibility of randomization.

b. To develop estimates of the percentages of distressed prostate cancer survivors and of those high and low in social comparison orientation in order to more effectively plan for a larger trial. The latter will provide data about our ability to conduct moderator analyses on social comparison orientation.
a. To estimate effect sizes for distressed patients in a heterogeneous support group program (distressed and non-distressed patients) and a homogeneous support group program (distressed patients only) on outcome variables of psychological functioning and QOL at 3 months. The effect sizes will be used in calculating sample size and power for a future trial.

2b. To estimate the effects on distressed patients of a heterogeneous group program and a homogeneous group program on hypothesized mediators (cognitive processing, coping skills, social support) at 3 months and explore correlations between mediators and distress.

2c. To explore changes in distress in the non-distressed patients participating in the heterogeneous group. We will examine our results in the context of existing data of non-distressed patients participating in the control arm of the randomized trial for PC-SMART (see preliminary studies).

2d. To explore differences in distressed and non-distressed patients on measures of social comparison coping and social comparison orientation and examine changes in these measures following intervention participation.

Condition	Intervention
Prostate Cancer	Behavioral: Group Meetings Behavioral: Questionnaire

Study Type:	Observational
Study Design:	Case Control, Retrospective
Official Title:	Efficacy of Prostate Cancer Support Programs: A Social Comparison Theory Analysis

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To study if a support group program is acceptable for patients with prostate cancer. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	240
Study Start Date:	May 2009
Estimated Primary Completion Date:	November 2011 (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 prostate 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. There will be no cost to you for taking part in this study. The study will pay for parking for study-related visits.

Up to 240 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Participants, 21 years of age or older, diagnosed with Prostate Cancer.

Criteria

Inclusion Criteria:

Diagnosis of adenocarcinoma of the prostate, 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798187

Contacts

Contact: Cindy L Carmack Taylor, PHD

713-745-3582

Locations

United States, Texas
The University of Texas M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Cindy L Carmack Taylor, PHD

M.D. Anderson Cancer Center

More Information

Additional Information:

The University of Texas M.D.Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Cindy Carmack Taylor, PHD/Associate Professor )
Study ID Numbers:	2008-0594
Study First Received:	November 24, 2008
Last Updated:	July 8, 2009
ClinicalTrials.gov Identifier:	NCT00798187 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Prostate
Behavioral Intervention
Cancer Support Programs

Social Comparison
Heterogeneous support group
Homogeneous support group

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009