MDACC Study Summary 2009-0976

Study Summary
No. 2009-0976:.......Breast......Lorenzo Cohen......Behavioral Science

Study Summary Title



Study Summary Number:	2009-0976

Study Title:	Biobehavioral effects of Relaxation for women with breast cancer undergoing radiotherapy

Physician

New Patient Referral



Name:	Lorenzo Cohen	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:	713-745-4260 Contact us about clinical trials

General Information



Disease Group:	Breast	Supported By:	N/A

Phase of Study:	Phase III	Return Visit:	Intervention and assessments will be scheduled around the patients' projected time of treatment and follow-up visits as per current MDACC care plan.

Treatment Agents:	Exercise	Home Care:	Participants will be encouraged to practice at home on the days that they are not in class at MDACC.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	None

Description/
Intervention:

The goal of this behavioral research study is to compare two different forms of
relaxation programs that will include stretching and relaxation techniques, in
order to learn if and how well they may help to improve physical and emotional
well-being. This will be tested in patients with breast cancer who are
receiving radiation therapy. For comparison purposes, there will also be a
group of participants that does not take part in the relaxation programs.

Study Objectives / Outcomes

Our specific aims in the proposed study are to:

1. Examine the efficacy of a yoga program incorporated into the treatment schedule for women with breast cancer undergoing radiotherapy. Our primary aim will be to determine the extent to which the yoga program improves physical aspects of quality of life during and after treatment as compared to a stretching/relaxation or a waitlist control group.

2. Determine the effects of the yoga program on other aspects of adjustment. This will consist of examining fatigue, sleep disturbances, other aspects of quality of life (QOL), mental health, cost-effectiveness analysis, work and/or home productivity, and cortisol rhythmicity.

3. Identify some of the processes underlying the efficacy of the intervention. A cognitive-social model drawn from existing research on trauma and the management of life-threatening illnesses will be evaluated to identify factors that mediate and/or moderate the effects of the intervention and predict adjustment. We will evaluate cognitive/emotional processing, ability to find meaning in the illness experience, and spirituality.

Study Status Information



Study Activation / Registration Date:	02/10/2011

IRB Review and Approval Date:	02/10/2011

Study Type:	Behavioral

Recruitment Status:	Open

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) Women with stage 0 - III breast cancer who will be undergoing daily adjuvant radiation for 4-6 weeks (patients only).

2) 18 years of age or older (patient and spouse/partner).

3) Able to read, write, and speak English or Spanish (patient and spouse/partner).

Exclusion Criteria:

1) Patients who have any major psychiatric diagnoses (e.g., schizophrenia, bipolar disorder).

2) Patients who have not undergone any surgical treatment for their cancer.

3) Patients with extreme mobility issues (e.g., unable to get in and out of a chair unassisted).

4) Patients who have practiced yoga or taken yoga classes in the year prior to study enrollment or who are currently engaged in a regular mind-body practice

Links

Registration Number: NCT01202851
Study Information on Clinical Trials Registry (clinicaltrials.gov)