Efficacy of Distant Healing in Glioblastoma Treatment

August 17, 2006 updated by: National Center for Complementary and Integrative Health (NCCIH)
This study will assess whether distant healing effects survival time and loss of function for glioblastoma patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Andrew Freinkel, MD, California Pacific Medical Center Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Study Completion

June 1, 2005

Study Registration Dates

First Submitted

January 23, 2002

First Submitted That Met QC Criteria

January 23, 2002

First Posted (Estimate)

January 24, 2002

Study Record Updates

Last Update Posted (Estimate)

August 18, 2006

Last Update Submitted That Met QC Criteria

August 17, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AT000644-03 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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