Trial Information

Cross-disciplinary Evaluation of Efficacy and Effectiveness of Individualized Complementary Therapies: Evaluating Personalized Effect of Energy Healing as an Individualized Intervention

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.

Hypotheses:

- The effects found will be larger for the primary, personalized, outcomes (MYCaW) than
when assessed with standardized measures.

- Patients that self-select energy healing will experience larger effects for primary
outcomes than patients that randomized to the intervention.

- The primary, personalized outcomes will change more during the course of the treatment
in the intervention groups than in the control groups.

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?

Hypotheses:

- No significant effects of healing on secondary, standardized, outcomes (Physical health
survey, physical activity, QoL, Depressive symptoms, mood) are anticipated.

- No significant effect on levels of daily physical performance as reported in diaries is
anticipated.

- Participants that self-select energy healing will report significantly larger effects
on secondary outcomes than patients randomized to intervention.

- No significant effect on participants' self-reported burden of late effects is
anticipated.

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.

Hypotheses:

- The effect of healing will be larger, if participants o report higher levels of
"absorption" (i.e. "openness to experience")

- report higher expectations of benefits

- report previous positive experience with CAM

- report a positive attitude towards CAM

- report prior experience with energy healing

- report faith in God or a higher spiritual power

- experience a better healer-patient relationship

- Those that change their primary selected outcome over the course of treatment will
score higher on the questionnaire relating to the healer-patient relationship.

Further, it is expected that the qualitative analysis will shed light on whether and how

- participants subjectively express a change in their perception of self and illness
corresponding with the healer's recommendations;

- ritualization of the healing session provides for participants' subjective
acknowledgement of the healer-patient relationship;

The quantitative and qualitative data in combination are expected to confirm the following
hypothesis:

- If the healer is able to ritualize, orchestrate and 'key' the performance of the
healing ritual by means of stylistic devices as e.g. the burning of incense, music,
etc., and if he/she is a skilled symbol manager, and if the participant subjectively
acknowledge these aspects, the participant will score high on standardized
questionnaires.

TERTIARY OUTCOMES

Finally, a number of issues will be explored relating to the value attributed to the
treatment by the participants. It will be explored:

- How much money are the participants in the intervention groups willing to spend on this
kind of therapy

- How far a distance participants are willing to drive to receive this kind of therapy

STUDY DESIGN

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.

RECRUITMENT

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.

RANDOMIZATION

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.

ASSESSMENT

Questionnaires:

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.

Diaries:

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.

Participant-observation:

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.