Evaluating Personalized Effect of an Individualized Intervention
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Energy healing
Intervention type(s): Procedure
Intervention description(s): "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 intervention name(s): Spiritual healing; Reiki
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: rehabilitation