Reiki/Energy Healing in Prostate Cancer

NCT00065208 | Completed Phase 1 DMC

• 1 other identifier: R21AT001120
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether Reiki energy healing affects anxiety and disease progression in patients with localized prostate cancer who are candidates for radical prostatectomy.

Conditions

Prostate Cancer

Keywords

Prostate cancer; Reiki; Energy Healing

Outcome Measures

Primary Outcomes (3)

• To evaluate the effects of Reiki on anxiety states using validated psychometric instruments.

  Each 30 minute session

• To evaluate the effects of Reiki on physiologic anxiety as measured by cortisol and DHEA levels

  Each 30 minute session

• To evaluate the effects of Reiki on cancer progression as measured by PSA levels in plasma.

  throughout study

Secondary Outcomes (1)

• To evaluate the effects of Reiki and guided imagery on post-surgical pain and urinary symptoms

  Throughout study

Study Arms (3)

Reiki

EXPERIMENTAL

Energy therapy

Behavioral: Reiki

Pretend Reiki

SHAM COMPARATOR

Behavioral: Pretend Reiki

Rest / Guided Imagery

OTHER

Rest for pre-surgery outcomes Guided Imagery for post-surgery outcomes

Behavioral: Rest / Guided Imagery

Interventions

Reiki BEHAVIORAL

Energy therapy - 8 biweekly sessions of 30 minutes

Also known as: Energy Therapy, Touch Therapy, Energy Healing

Reiki

Pretend Reiki BEHAVIORAL

Touch from untrained pretend practitioners. 8 biweekly sessions of 30 minutes

Also known as: Touch

Pretend Reiki

Rest / Guided Imagery BEHAVIORAL

4 weekly sessions of 30 supine rest listening to soft music. One session of Guided Imagery followed at visit 9. Listen to CDs twice a day 3 days prior to and 2 days following surgery (affect only post surgery outcomes)

Also known as: Guided Imagery

Rest / Guided Imagery

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed with prostate cancer
• Scheduled for radial prostatectomy, external beam radiation, brachytherapy, or a combination of these

You may not qualify if:

• Already involved in energy healing treatments
• Any patient whose medical intervention could not wait the 4-weeks for intervention for medical reasons
• Any patient who gets neo-adjuvant therapy or any herbal product that could affect PSA

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Therapeutic Touch; Touch; RE1-silencing transcription factor; Imagery, Psychotherapy

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; Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Joan Fox, Ph.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff

Study Record Dates

• First Submitted: July 18, 2003
• First Posted: July 22, 2003
• Study Start: April 1, 2005
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

US (1)