Clinical trial NCT00029783: Efficacy of Distant Healing in Glioblastoma Treatment
Official title: Efficacy of Distant Healing in Glioblastoma Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glioblastoma
Keywords: Glioblastoma
Brain tumor
Distant healing
Distance healing
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2002-01-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: California Pacific Medical Center Research Institute
state: California
Study officials:
affiliation: California Pacific Medical Center Research Institute
name: Andrew Freinkel, MD
role: PRINCIPAL_INVESTIGATOR
References: