Efficacy of Distant Healing in Glioblastoma Treatment
Primary Purpose
Glioblastoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Distant Healing
Sponsored by

About this trial
This is an interventional treatment trial for Glioblastoma focused on measuring Glioblastoma, Brain tumor, Distant healing, Distance healing
Eligibility Criteria
Inclusion: Histologically confirmed diagnosis of glioblastoma based on open resection. Patient is within five weeks of diagnosis confirmed by pathology report. Exclusion: Non-English speaking. Inability or unwillingness to fill out questionnaires. History of other cancers within the last 2 years (except superficial basal cell, squamous cell carcinoma of the skin), or other concurrent life-threatening conditions.
Sites / Locations
- California Pacific Medical Center Research Institute
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00029783
First Posted
January 23, 2002
Last Updated
August 17, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00029783
Brief Title
Efficacy of Distant Healing in Glioblastoma Treatment
Official Title
Efficacy of Distant Healing in Glioblastoma Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
Brief Summary
This study will assess whether distant healing effects survival time and loss of function for glioblastoma patients.
Detailed Description
Prayer, energy healing, and spiritual healing are widely used for all degrees of illness.
Eisenberg (1998) reported that more that 26% of his survey sample used "energy healing" within the last year. Most of these practitioners believe that their inner intentions result in the benefits, either through the agency of love, energy, or a Higher Power (Benor 1992). However, the conventional community attributes benefits from these interventions to the patient's hope, expectation, or experience of support from a practitioner (Benson 1996). The proposed study is a double-blind randomized controlled clinical trial of "distant healing intentionality." Distant Healing (DH) is defined as a "mental intention on behalf of one person, to benefit another at a distance." This study will assess whether DH effects survival time and loss of function for glioblastoma patients under conditions where hope and expectation are controlled. The study will include approximately 150 patients who have rapidly progressing glioblastoma and are beginning radiotherapy. Patients will be photographed and assessed for quality of life, psychological status, and physical symptoms as well as health habits and attitude toward DH. After stratification by age and functional status (Karnofsky score), patients will be randomly assigned to either standard treatment with or without DH. Healers from diverse schools and backgrounds from communities across the United States will be assigned to patients by rotation, so that each patient in the DH group will be treated for two weeks by 10 different healers over the 20 week intervention. Experienced healers will have photographs of subjects and send "mental intention for health and well being" to subjects for one hour daily, three times per week. The healing intervention will be performed at a distance, and patients and healers will never meet, nor will patients know their group assignment. The study findings will provide the basis for developing a larger study, definitive trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
Keywords
Glioblastoma, Brain tumor, Distant healing, Distance healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Distant Healing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion:
Histologically confirmed diagnosis of glioblastoma based on open resection.
Patient is within five weeks of diagnosis confirmed by pathology report.
Exclusion:
Non-English speaking.
Inability or unwillingness to fill out questionnaires.
History of other cancers within the last 2 years (except superficial basal cell, squamous cell carcinoma of the skin), or other concurrent life-threatening conditions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Freinkel, MD
Organizational Affiliation
California Pacific Medical Center Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Pacific Medical Center Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Distant Healing in Glioblastoma Treatment
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