Evaluating Personalized Effect of an Individualized Intervention
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Colorectal Cancer |
Procedure: Energy healing |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Cross-disciplinary Evaluation of Efficacy and Effectiveness of Individualized Complementary Therapies: Evaluating Personalized Effect of Energy Healing as an Individualized Intervention |
- Changes in personal concerns identified by the patient in the MYCaW questionnaire. [ Time Frame: Measured 10 days after baseline, 6 weeks after baseline (before third treatment), 10 weeks and 18 weeks after baseline ] [ Designated as safety issue: No ]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.
- Changes in Physical Health Survey [ Time Frame: 10 days, 10 weeks and 18 weeks after baseline ] [ Designated as safety issue: No ]Late complications
- Changes in SF-36 Physical activity [ Time Frame: 10 days, 10 weeks and 18 weeks after baseline ] [ Designated as safety issue: No ]Physical activity
- Changes in Facit-sp QoL [ Time Frame: Baseline, 10 weeks and 18 weeks after baseline ] [ Designated as safety issue: No ]Physical, emotional, social and spiritual well-being
- Changes in BDI-II depressive symptoms [ Time Frame: Baseline, 10 weeks and 18 weeks after baseline ] [ Designated as safety issue: No ]Depressive symptoms
- Changes in POMS Mood [ Time Frame: Baseline, 6 weeks after baseline (before and after third treatment), 10 weeks and 18 weeks after baseline ] [ Designated as safety issue: No ]Profile of mood states
- Changes in Daily physical performance [ Time Frame: 10 days, 10 weeks and 18 weeks after baseline ] [ Designated as safety issue: No ]Daily physical performance as reported in diaries
| Estimated Enrollment: | 325 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Self-selected energy healing
Self-selected healing in the self-selection arm
|
Procedure: Energy healing
"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.
Other Names:
|
|
No Intervention: self-selected control
Self-selected control in the self-selection arm
|
|
|
Experimental: randomized to energy healing
Randomized to healing in the randomization arm
|
Procedure: Energy healing
"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.
Other Names:
|
|
No Intervention: Randomized control
Randomized to control in the randomization arm
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Primary diagnosis of colorectal, breast and prostate cancer
- Completed treatment with intended cure and no current cancer
Exclusion Criteria:
- Unwillingness to comply with data collection protocol
- Mentally and cognitively incapable to participate in the study
- Poor understanding and expression of the Danish language
- In palliative care or cancer recurrence prior to inclusion
Contacts and Locations| Contact: Helle Johannessen, PhD | +4565503647 | hjohannessen@health.sdu.dk |
| Contact: Christina G Pedersen, PhD | +4586426696 | christina@psy.au.dk |
| Denmark | |
| Christina Gundgaard Pedersen | Recruiting |
| Aarhus, Denmark, 8000 | |
| Contact: Christina Gundgaard Pedersen, PhD 004587165879 christina@psy.au.dk | |
| Contact: Anita Lunde, Master 004565503815 alunde@health.sdu.dk | |
| Principal Investigator: | Helle Johannessen, PhD | University of Southern Denmark |
More Information
Additional Information:
No publications provided
| Responsible Party: | Helle Johannessen, Professor, mag.scient., PhD, University of Southern Denmark |
| ClinicalTrials.gov Identifier: | NCT01434264 History of Changes |
| Other Study ID Numbers: | 09-065176/DSF |
| Study First Received: | September 13, 2011 |
| Last Updated: | October 10, 2012 |
| Health Authority: | Denmark: Danish Dataprotection Agency |
Keywords provided by University of Southern Denmark:
|
rehabilitation |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on June 17, 2013