Evaluating Personalized Effect of an Individualized Intervention

This study has been completed.
Sponsor:
Collaborators:
University of Aarhus
The Ministry of Science, Technology and Innovation, Denmark
Information provided by (Responsible Party):
Helle Johannessen, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01434264
First received: September 13, 2011
Last updated: March 7, 2014
Last verified: March 2014
  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

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 247
Study Start Date: September 2011
Study Completion Date: November 2012
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:
  • Spiritual healing
  • Reiki
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:
  • Spiritual healing
  • Reiki
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
Criteria

Inclusion Criteria:

  1. Primary diagnosis of colorectal, breast and prostate cancer
  2. Completed treatment with intended cure and no current cancer

Exclusion Criteria:

  1. Unwillingness to comply with data collection protocol
  2. Mentally and cognitively incapable to participate in the study
  3. Poor understanding and expression of the Danish language
  4. In palliative care or cancer recurrence prior to inclusion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434264

Locations
Denmark
Christina Gundgaard Pedersen
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Southern Denmark
University of Aarhus
The Ministry of Science, Technology and Innovation, Denmark
Investigators
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: March 7, 2014
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 July 24, 2014