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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Clair Beard, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00207259
First received: September 13, 2005
Last updated: February 14, 2013
Last verified: February 2013
  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:

  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

Condition Intervention Phase
Prostate Cancer
Behavioral: Reiki & Relaxation Response Therapy with Cognitive Restructuring
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Complementary Therapies in Men Receiving Radiation Therapy for Prostate Cancer: A Feasibility Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Obtain preliminary results on the effectiveness of these treatments compared to controls [ Time Frame: Measurements taken at multiple time points ] [ Designated as safety issue: No ]
    QOL testing performed at four time points


Enrollment: 60
Study Start Date: March 2005
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Standard weekly treatments with radiation oncologist and nurse. All control patients offered intervention at end of 8-week course of radiotherapy.
Experimental: Relaxation Therapy
Weekly relaxation therapy with PhD psychologist and home cognitive restructering practice
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.

Other Names:
  • Relaxation Therapy
  • Reiki therapy
Experimental: Reiki
Weekly Reiki therapy with a Reiki therapist, involves laying of the therapist's hands on the patient to rechannel energy, considered pleasant and calming
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.

Other Names:
  • Relaxation Therapy
  • Reiki therapy

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  1. Prior pelvic radiotherapy
  2. Evidence of metastatic disease
  3. Currently receiving ongoing psychotherapy or antidepressive medications
  4. Non-English speaking
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Clair Beard, Attending Physician, Vice-Chair, Genitourinary Radiaton Oncology, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00207259     History of Changes
Other Study ID Numbers: 05-005
Study First Received: September 13, 2005
Last Updated: February 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Prostate Cancer
Reiki
Relaxation Response
Cognitive Restructuring
Feasibility

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 25, 2014