Reiki/Energy Healing in Prostate Cancer

Study Overview
=================
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.

Detailed Description
-----------------
120 newly diagnosed prostate cancer patients will be randomized to one of 3 groups: Reiki, another touch therapy, or guided imagery. Subjects in the Reiki and touch therapy groups have 8 sessions in the 4 weeks prior to their medical intervention. Those in the imagery group have one session prior to their medical intervention.

Official Title
-----------------
Effects of Energy Healing on Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Behavioral: Reiki
* Behavioral: Pretend Reiki
* Behavioral: Rest / Guided Imagery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Newly diagnosed with prostate cancer Scheduled for radial prostatectomy, external beam radiation, brachytherapy, or a combination of these Exclusion criteria: 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
Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reiki<br>Energy therapy | Behavioral: Reiki<br>* Energy therapy - 8 biweekly sessions of 30 minutes<br>* Other names: Energy Healing;|
| Sham Comparator: Pretend Reiki<br> | Behavioral: Pretend Reiki<br>* Touch from untrained pretend practitioners. 8 biweekly sessions of 30 minutes<br>* Other names: Touch;|
| Other: Rest / Guided Imagery<br>Rest for pre-surgery outcomes Guided Imagery for post-surgery outcomes | Behavioral: Rest / Guided Imagery<br>* 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)<br>* Other names: Guided Imagery;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effects of Reiki and guided imagery on post-surgical pain and urinary symptoms |  | Throughout study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate cancer, Reiki, Energy Healing