MDACC Study Summary 2007-0825

Study Summary
No. 2007-0825:.......Anus; Rectum......Lorenzo Cohen......Behavioral Science

Study Summary Title



Study Summary Number:	2007-0825

Study Title:	Biobehavioral Effects of Qigong During Rectal and/or Anal Cancer Treatment

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:	Anus Rectum	Supported By:	National Cancer Institute

Phase of Study:	N/A	Return Visit:	21; baseline + 3 x week for 6 weeks + 2 follow ups

Treatment Agents:	None	Home Care:	NA

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	NA

Description/
Intervention:

The goal of this behavioral research study is to learn if taking part in a
qigong program (a movement-based therapy of breathing and imagery to help
reduce stress) helps to improve the quality of life, including both physical
and psychological well-being, of people who are being treated for rectal and/or
anal cancer. Researchers also want to learn if a qigong program helps to lower
emotional distress.

Study Objectives / Outcomes

Our specific aims in the proposed study are to:

1. Pilot-test a Qigong program to determine the acceptability and feasibility of teaching Qigong to patients with rectal and/or anal cancer undergoing chemoradiotherapy. This will be accomplished by evaluating patient interest during the recruitment period, study attrition, patient satisfaction, Qigong session attendance, frequency of practicing the exercises outside the hospital, and completion of questionnaires.

2. Conduct an initial evaluation of whether participation in the Qigong program improves patients' fatigue and sleep disturbances. Secondary endpoints will include examining other aspects of quality of life (QOL) and mental health, and objective physiological outcomes (saliva samples for cortisol levels). Exploratory analyses will examine some plausible mediators of the Qigong program, including cognitive processing, spirituality, and finding meaning in the cancer experience.

Study Status Information



Study Activation / Registration Date:	01/20/2009

IRB Review and Approval Date:	02/07/2008

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) Patients with stage I - IV rectal and/or anal cancer who will be undergoing daily chemoradiation.

2) Participants must be at least 18 years old.

3) Participants should be able to read, write, and speak English.

Exclusion Criteria:

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

2) Patients with any physical disabilities resulting in an inability to walk unassisted, experience chronic pain while walking, or have difficulty walking without rest for up to 20 minutes.

3) Patients who have practiced Qigong or taken Qigong classes in the year prior to diagnosis.

4) Metastatic disease of the bone because of the possible risk of bone fractures resulting from qigong and exercise movements.

Links

Registration Number: Not Applicable Clinical Trial