MDACC Study Summary 2008-0594

Study Summary
No. 2008-0594:.......Breast; Prostate......Cindy L. Carmack......Behavioral Science

Study Summary Title



Study Summary Number:	2008-0594

Study Title:	Efficacy of Cancer Support Programs: A Social Comparison Theory Analysis

Physician

New Patient Referral



Name:	Cindy L. Carmack	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Behavioral Science	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-3582 Contact us about clinical trials

General Information



Disease Group:	Breast Prostate	Supported By:	National Cancer Institute

Phase of Study:	N/A	Return Visit:	Participants will come to MDACC for two assessment sessions (baseline and 3 months) and 10 weekly groups sessions.

Treatment Agents:	Behavioral Intervention	Home Care:	Participants are taught new cognitive-behavioral skills each week during the group session and are encouraged to practice the skills at home.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A

Description/
Intervention:

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.

Study Objectives / Outcomes

We propose the following 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.
1b. To develop estimates of the percentages of distressed prostate cancer and breast 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.
2a. 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.

Study Status Information



Study Activation / Registration Date:	05/28/2009

IRB Review and Approval Date:	10/28/2008

Study Type:	Behavioral

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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

Links

Registration Number: NCT00798187
Study Information on Clinical Trials Registry (clinicaltrials.gov)