Cross-disciplinary Evaluation of Efficacy and Effectiveness of Individualized Complementary Therapies: Evaluating Personalized Effect of Energy Healing as an Individualized Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 247
- 试验地点
- 1
- 主要终点
- Changes in personal concerns identified by the patient in the MYCaW questionnaire.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of colorectal, breast and prostate cancer
- •Completed treatment with intended cure and no current cancer
排除标准
- •Unwillingness to comply with data collection protocol
- •Mentally and cognitively incapable to participate in the study
- •Poor understanding and expression of the Danish language
- •In palliative care or cancer recurrence prior to inclusion
研究组 & 干预措施
Randomized control
Randomized to control in the randomization arm
Self-selected energy healing
Self-selected healing in the self-selection arm
干预措施: Energy healing (Procedure)
self-selected control
Self-selected control in the self-selection arm
randomized to energy healing
Randomized to healing in the randomization arm
干预措施: Energy healing (Procedure)
结局指标
主要结局
Changes in personal concerns identified by the patient in the MYCaW questionnaire.
时间窗: 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.
次要结局
- Changes in Physical Health Survey(10 days, 10 weeks and 18 weeks after baseline)
- Changes in SF-36 Physical activity(10 days, 10 weeks and 18 weeks after baseline)
- Changes in Facit-sp QoL(Baseline, 10 weeks and 18 weeks after baseline)
- Changes in BDI-II depressive symptoms(Baseline, 10 weeks and 18 weeks after baseline)
- Changes in POMS Mood(Baseline, 6 weeks after baseline (before and after third treatment), 10 weeks and 18 weeks after baseline)
- Changes in Daily physical performance(10 days, 10 weeks and 18 weeks after baseline)
研究者
Helle Johannessen
Professor, mag.scient., PhD
University of Southern Denmark