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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00207259
First Posted: September 21, 2005
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Clair Beard, Brigham and Women's Hospital
  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
Prostate Cancer Behavioral: Reiki & Relaxation Response Therapy with Cognitive Restructuring

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Clair Beard, 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 ]
    QOL testing performed at four time points


Enrollment: 60
Study Start Date: March 2005
Study Completion Date: June 15, 2017
Primary Completion Date: June 15, 2017 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: July 13, 2017
Last Verified: July 2017

Keywords provided by Clair Beard, 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