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

NCT00207259 | Completed DMC

• 1 other identifier: 05-005
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Reiki; Relaxation Response; Cognitive Restructuring; Feasibility

Outcome Measures

Primary Outcomes (1)

• Obtain preliminary results on the effectiveness of these treatments compared to controls

  QOL testing performed at four time points

  Measurements taken at multiple time points

Study Arms (3)

Control

NO INTERVENTION

Standard weekly treatments with radiation oncologist and nurse. All control patients offered intervention at end of 8-week course of radiotherapy.

Relaxation Therapy

EXPERIMENTAL

Weekly relaxation therapy with PhD psychologist and home cognitive restructering practice

Behavioral: Reiki & Relaxation Response Therapy with Cognitive Restructuring

Reiki

EXPERIMENTAL

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

Interventions

Reiki & Relaxation Response Therapy with Cognitive Restructuring BEHAVIORAL

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.

Also known as: Relaxation Therapy, Reiki therapy

Reiki; Relaxation Therapy

Eligibility Criteria

• Age: 30 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Therapeutic Touch; Cognitive Restructuring; Relaxation Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Clair Beard, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Vice-Chair, Genitourinary Radiaton Oncology

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: March 1, 2005
• Primary Completion: June 15, 2017
• Study Completion: June 15, 2017
• Last Updated: July 13, 2017

Record last verified: 2017-07

Locations

US (1)