Evaluating Personalized Effect of an Individualized Intervention
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|ClinicalTrials.gov Identifier: NCT01434264|
Recruitment Status : Completed
First Posted : September 14, 2011
Last Update Posted : March 10, 2014
|First Submitted Date ICMJE||September 13, 2011|
|First Posted Date ICMJE||September 14, 2011|
|Last Update Posted Date||March 10, 2014|
|Study Start Date ICMJE||September 2011|
|Actual Primary Completion Date||November 2012 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||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 ]
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.
|Original Primary Outcome Measures ICMJE||Same as current|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Evaluating Personalized Effect of an Individualized Intervention|
|Official Title ICMJE||Cross-disciplinary Evaluation of Efficacy and Effectiveness of Individualized Complementary Therapies: Evaluating Personalized Effect of Energy Healing as an Individualized Intervention|
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.
PRIMARY OUTCOMES AND HYPOTHESES
The primary outcome is to investigate whether "energy healing" as an individualized form of treatment can improve personal concerns identified by the individual patient in the MYCaW questionnaire.
SECONDARY OUTCOMES AND HYPOTHESES
Secondary outcomes concern three independent but related areas: (1) Will energy healing have a statistically significant (p < 0.05) effect on secondary outcomes assessed with standardized, validated instruments, including physical health survey, physical activity, cancer-related QoL, depressive symptoms, and mood? (2) Will energy healing have a positive impact on daily physical performance as subjectively described in dairies? (3) Will energy healing influence participants' subjective experience of their illness and recovery? (4) Will energy healing influence participants' self-reported burden of late effect after cancer treatment?
Further, it is expected that the qualitative analysis will inform whether the energy healing provides participants with images that are embodied in their perception of self, illness and recovery and whether this is acknowledged by participants as meaningful for them in the particular situation in which they are embedded.
HYPOTEHSES RELATED TO MEDIATION AND MODERATION OF EFFECTS
A number of factors are anticipated to mediate and moderate the effects of energy healing.
Further, it is expected that the qualitative analysis will shed light on whether and how
The quantitative and qualitative data in combination are expected to confirm the following hypothesis:
Finally, a number of issues will be explored relating to the value attributed to the treatment by the participants. It will be explored:
The study is a pragmatic trial allowing healers to adjust the intervention (energy healing) to each participant and to undertake treatment-related communication as usual. The study is designed to allow for analysis of the implications of self-selection by randomizing participants to a self-selection arm and a randomized arm, each arm with corresponding control groups. Finally, the study design allows participants to identify what they consider to be their primary outcomes by using open outcome forms and semi-structured interviews in conjunction with validated, standard measures. In order to encompass the expected variation in primary outcomes and to investigate the interrelations of different types of outcomes, the study is designed as a cross-disciplinary investigation.
125 persons for the treatment groups and 200 persons for the control groups will be recruited in two ways; 1) Lists of patients who have completed their hospital treatment for colorectal, breast and prostate cancer within the last 12 months will be extracted from The National Patient Registry, and, 2) lists of patients who have completed intended curative treatment for colorectal cancer within the last month will be provided by the involved hospital departments from the Region of Southern Denmark. All patients considered eligible are randomized to self-selection arm (SSA) or randomization arm (RA) and mailed: 1) A letter inviting them to participate in the study, 2) Information about the study and the group they are assigned to, 3) A baseline questionnaire, 4) An informed consent form, allowing them to be contacted by the research team and a healer, and 5) A pre-paid return envelope. All invited persons are then contacted by telephone in order to answer any questions they may have concerning the study. Persons willing to participate are asked to complete the baseline questionnaire and the informed consent form and return these. Persons who are unwilling to participate will be asked for the reasons and a drop-out register will be established. After two consecutive reminder calls and no response, a participant will be considered a drop-out (see Figure 1).
After allocation of participants to healers, the healers are contacted by telephone and letter with information on the participants and repetition of the procedure to be followed. The healers will arrange contacts to the participants who have been assigned to receive energy healing within two days in order to agree on a date for the first session.
All project procedures will be administered and organized using an encrypted ACCESS database aligned with the study protocol procedures. Day-to-day data collection activities will thus be based on computerized enquiries, and all procedural and unplanned events, such as i.e. patient telephone calls, will be registered.
Possible participants are initially and before the first contacts randomized to SSA and RA by a centralized, computerized procedure, e.g. the Minim (Minimisation Program for Allocating Patients to Treatments in Clinical Trials). Stratified; The sample will be stratified according to type of cancer and gender.
Following the reception of baseline questionnaires and informed consent form from the group randomized to the RA, the RA is further randomized to intervention and control groups by a similar procedure.
Baseline questionnaires will be administrated before first treatment. Additional questionnaire packages will be administered to the participants 10 days, 10 weeks and 18 weeks after baseline. Additionally, those in the healing intervention groups complete questionnaire packages immediately before and after their third healing session. For comparison the control groups complete a questionnaire package 6 weeks after baseline.
20 participants from each of the four groups are asked to fill in an activity diary (conc. activities from sleep to strenuous activity) and time consumption (minutes and hours) during the day. The activity diary will be completed for seven days at baseline, seven days at week 10 and seven days at week 18.
Qualitative semi-structured interviews:
8 participants from each of the two intervention groups and control groups will be included for qualitative interviews and participant observation. The interviews and participant-observation will be conducted before and after the treatments and enable comparison of dispositions and processes of change. Interviewees will be selected to ascertain distribution in age and previous use of CAM (particularly energy healing). All interviews will be recorded if the participants are comfortable with it.
12 participants will be followed with 1 day's participant-observation before the first treatment and 2 days' participant-observation after the final treatment in settings, which the patient consider as important domains in his/her life and in the 'returning-to-life' process. Further, participant-observation will be conducted in some of the clinics involved in the trial.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
|Condition ICMJE||Colorectal Cancer|
|Intervention ICMJE||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.
|Study Arms ICMJE||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Actual Enrollment ICMJE
|Original Estimated Enrollment ICMJE
|Actual Study Completion Date ICMJE||November 2012|
|Actual Primary Completion Date||November 2012 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages ICMJE||18 Years to 80 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Denmark|
|Removed Location Countries|
|NCT Number ICMJE||NCT01434264|
|Other Study ID Numbers ICMJE||09-065176/DSF|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement ICMJE||Not Provided|
|Responsible Party||Helle Johannessen, University of Southern Denmark|
|Study Sponsor ICMJE||University of Southern Denmark|
|PRS Account||University of Southern Denmark|
|Verification Date||March 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP