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

NCT00207259 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-07-13

No results posted yet for this study

Summary

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:

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

Conditions

Interventions

BEHAVIORAL

Reiki & Relaxation Response Therapy with Cognitive Restructuring

Relaxation Therapy: Practice of focus on breathing or repeated word while ignoring random thoughts without bias. Designed to lower heart rate, blood pressure and stress. Reiki: Practice of laying on hands by a Reiki therapist in order to channel patient's energy, considered calming and pleasant.

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Clair Beard, MD · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
30 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2017-06-15
Completion
2017-06-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00207259 on ClinicalTrials.gov