MDACC Study Summary 2004-0024

Study Summary
No. 2004-0024:.......Breast; Gastrointestinal; Gynecology; Prostate......Lorenzo Cohen......Behavioral Science

Study Summary Title



Study Summary Number:	2004-0024

Study Title:	Chemotherapy and Mindfulness Relaxation: A Randomized Trial at M.D. Anderson Cancer Center and M.D. Anderson Community Clinical Oncology Program

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:	713-792-0919 Contact us about clinical trials

General Information



Disease Group:	Breast Gastrointestinal Gynecology Prostate	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Participants will have 4 study related visits during the course of this trial. These will be at baseline, in the middle of their course of therapy, at the end of treatment, and at approximately 3 months (90-120 days) post treatment.

Treatment Agents:	None	Home Care:	Patients will be asked to fill out a diary for a total of 7 days for each chemo session. Patients will write in their diary 3 days before their chemo session, on the day of their chemo session, and for 3 days after each chemo session.

Treatment Loc:	MDACC + Community Programs (CCOP/Network)

Estimated Length of Stay in Houston:	No hospitalization is required for this study.

Description/
Intervention:

The goal of this research study is to see if there are techniques available to
treat and/or prevent the feelings of nausea and vomiting that can occur when
you receive chemotherapy. Researchers will study if a technique called
Mindfulness Relaxation has any effect on your feelings of anxiety, depression
(sadness), distress, your cancer related symptoms of fatigue (tiredness),
sleep, pain, and your immune function (how well your body can fight infection).

Mindfulness relaxation is a technique to help you quiet the thoughts in your
mind, and relax your body before and during chemotherapy.

Study Objectives / Outcomes

Primary Objective
To determine the value of mindfulness relaxation [MR] as a method for alleviating and/or preventing the development of conditioned and nonconditioned nausea and vomiting.

Secondary Objectives
1. To determine the effects of the MR intervention on mental health (anxiety, depression, and distress), quality of life (cancer related symptoms, fatigue, sleep and pain), and immune function.

2. To examine a model developed to explore factors that may mediate the effects of the intervention and/or predict adjustment and recovery.

Study Status Information



Study Activation / Registration Date:	05/13/2004

IRB Review and Approval Date:	02/18/2004

Study Type:

Recruitment Status:	Open

Projected Accrual:	499

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) are >/= 18 years of age

2) are anticipated to undergo at least four cycles of chemotherapy treatment

3) have had no previous treatment with chemotherapy

4) have no evidence of distant metastatic disease

5) can read/speak in English or Spanish

6) have no known psychotic diagnosis

7) have an expected survival of at least 6 months

Exclusion Criteria:

1) have a known psychotic diagnosis

2) will undergo an undefined number of chemotherapy regimens

Links

Registration Number: NCT00086762
Study Information on Clinical Trials Registry (clinicaltrials.gov)