Evaluating Personalized Effect of 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.