Evaluating Personalized Effect of an Individualized Intervention
Cross-disciplinary Evaluation of Efficacy and Effectiveness of Individualized Complementary Therapies: Evaluating Personalized Effect of Energy Healing as an Individualized Intervention
1 other identifier
interventional
247
1 country
1
Brief Summary
Energy healing is among the most commonly used forms of complementary and alternative medicine among cancer patients. There are, however, few studies on the effects of energy healing for cancer and cancer associated symptoms and none of them are of a volume or quality that allows reliable conclusions to be drawn. Qualitative studies on energy healing in Denmark have demonstrated that the interventions are individualized and the expected outcomes personalized. This research points to the need for a research design that can evaluate personalized outcomes of individualized treatments and at the same time adhere to general demands of external and internal validity. The objective of this study is to test the effectiveness of energy healing as an individualized rehabilitative intervention to improve outcomes of personal choice among persons who have completed a conventional intended curative treatment for colorectal, breast and prostate cancer. The study is designed as a pragmatic clinical trial with personalized outcomes. The study attempts to maximize external validity by using a design that incorporates important features of energy healing administered in real-life settings: 1a) allowing participants self-selection to healing and non-healing control, 1b) assessing individual participant-selected treatment goals, 1c) allowing the treatment to be performed in the private clinics of the healers. To maximize internal validity similar to that obtained in a randomized, clinical trial design, the study will 2a) randomize participants to self-selection and randomized groups of intervention and control; and 2b) supplement the assessment of personalized treatment goals with assessment of outcomes with standardized measures. The study will account for a number of possible moderators of the effects, including 3a) socio-demographics and 3b) previous experience with complementary and alternative treatment. Outcome measures will be assessed by questionnaires, physical measurements, data from administrative registries as well as semi-structured interviews and participant observation. Possible patterns in the various forms of data will be examined for concordances and discrepancies. Finally, the methods will be discussed in terms of their generalizability as a model for evaluating personal outcomes of individualized treatments with high levels of external and internal validity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable colorectal-cancer
Started Sep 2011
Shorter than P25 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 13, 2011
CompletedFirst Posted
Study publicly available on registry
September 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedMarch 10, 2014
March 1, 2014
1.2 years
September 13, 2011
March 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in personal concerns identified by the patient in the MYCaW questionnaire.
The primary outcome is to investigate whether "energy healing" as an individualized form of treatment can improve personal concerns identified by the patient in the MYCaW questionnaire.
Measured 10 days after baseline, 6 weeks after baseline (before third treatment), 10 weeks and 18 weeks after baseline
Secondary Outcomes (6)
Changes in Physical Health Survey
10 days, 10 weeks and 18 weeks after baseline
Changes in SF-36 Physical activity
10 days, 10 weeks and 18 weeks after baseline
Changes in Facit-sp QoL
Baseline, 10 weeks and 18 weeks after baseline
Changes in BDI-II depressive symptoms
Baseline, 10 weeks and 18 weeks after baseline
Changes in POMS Mood
Baseline, 6 weeks after baseline (before and after third treatment), 10 weeks and 18 weeks after baseline
- +1 more secondary outcomes
Study Arms (4)
Self-selected energy healing
EXPERIMENTALSelf-selected healing in the self-selection arm
self-selected control
NO INTERVENTIONSelf-selected control in the self-selection arm
randomized to energy healing
EXPERIMENTALRandomized to healing in the randomization arm
Randomized control
NO INTERVENTIONRandomized to control in the randomization arm
Interventions
"Healer-Ringen", a Danish national association of healers, selects healers with an educational background as required by the Registry of Alternative Practitioners (RAB) and have rooms reserved for the healing practice. The treatment takes place in the clinic of the healer and is not restricted in respect to what form of energy healing that shall be used, provided that it is based on the idea of the healer providing some kind of energy by the hands to the participant. Conversation as usual is accepted, but no other form of therapy may be provided. The intervention consists of four sessions over a period of two months, distributed as decided by each participant-healer pair.
Eligibility Criteria
You may qualify if:
- Primary diagnosis of colorectal, breast and prostate cancer
- Completed treatment with intended cure and no current cancer
You may not qualify if:
- Unwillingness to comply with data collection protocol
- Mentally and cognitively incapable to participate in the study
- Poor understanding and expression of the Danish language
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Denmarklead
- University of Aarhuscollaborator
- The Ministry of Science, Technology and Innovation, Denmarkcollaborator
Study Sites (1)
Christina Gundgaard Pedersen
Aarhus, 8000, Denmark
Related Publications (1)
Agdal R. "Is the Pain a Sign of Healing?": Cancer Patients' Experiences of Energy Healing in a Pragmatic Trial. Integr Cancer Ther. 2022 Jan-Dec;21:15347354221118328. doi: 10.1177/15347354221118328.
PMID: 36154510DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helle Johannessen, PhD
University of Southern Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, mag.scient., PhD
Study Record Dates
First Submitted
September 13, 2011
First Posted
September 14, 2011
Study Start
September 1, 2011
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
March 10, 2014
Record last verified: 2014-03