Study of Complementary Therapies in Men Receiving Radiation Therapy for Prostate Cancer: A Feasibility Trial - Full Text View

Sponsored by:	Brigham and Women's Hospital
Information provided by:	Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00207259

Purpose

Randomized clinical study of two CAM therapies, 1) Reiki and 2) Relaxation Response Therapy with Cognitive Restructuring counseling (RRT with CR), compared to an education-only control arm in patients about to begin an eight-week course of external beam radiotherapy (EBRx) for prostate cancer.

Generally, we would like to examine the feasibility of studying Reiki and RRT with CR in patients with prostate cancer, and to obtain preliminary results on the effectiveness of these treatments compared to controls.

Specific objectives:

Determine the proportion of eligible patients who agree to participate in the study
Measure compliance with CAM therapy interventions
Measure compliance with physiologic and psychological outcome measurement assessments
Assess differences between experimental and control groups on measures on depression, anxiety, quality of life, salivary cortisol levels and an immunomarkers

Condition	Intervention
Prostate Cancer	Procedure: Reiki & Relaxation Response Therapy with Cognitive Restructuring

MedlinePlus related topics: Cancer Cancer Alternative Therapies Complementary and Alternative Medicine Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Factorial Assignment
Official Title:	Study of Complementary Therapies in Men Receiving Radiation Therapy for Prostate Cancer: A Feasibility Trial

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:

Explore feasibility of studying Reiki and Relaxation Response Therapy with Cognitive Restructuring in patients with prostate cancer
Obtain preliminary results on the effectiveness of these treatments compared to controls

Estimated Enrollment:	60
Study Start Date:	March 2005

Show Detailed Description

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age > 30
Histologic documentation of prostate cancer (no time limit)
Gleason score assignment is mandatory prior to entry
ECOG Performance Status of 0, 1, or 2
Clinical Stage Tl – T4 adenocarcinoma of the prostate
Planned androgen suppression therapy prior to an eight-week course of external beam radiotherapy
Signed Informed Consent

Exclusion Criteria:

Prior pelvic radiotherapy
Evidence of metastatic disease
Currently receiving ongoing psychotherapy or antidepressive medications
Non-English speaking

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207259

Locations

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Brigham and Women's Hospital

Investigators

Principal Investigator:

Clair Beard, MD

Dana-Farber Cancer Institute

More Information

Study ID Numbers:	05-005
Study First Received:	September 13, 2005
Last Updated:	April 23, 2007
ClinicalTrials.gov Identifier:	NCT00207259
Health Authority:	United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:

Prostate Cancer
Reiki
Relaxation Response
Cognitive Restructuring
Feasibility

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009