About this trial
The use of complementary and integrative medicine (CIM) among oncology patients is widespread, with a large body of research-based evidence supporting the ability of these therapies to alleviate symptoms related to cancer and its treatment. Organizations such as the American Society for Clinical Oncology and the European Society for Medical Oncology have included CIM modalities in their treatment guidelines, and many of today's leading cancer centers include CIM in their supportive care service. The proposed study will prospectively examine the impact of a CIM treatment program on the symptom burden, quality of life and function of patients undergoing active oncology treatment.
A total of 750 patients will undergo an integrative oncologist (IP) consultation followed by a series of 8 CIM treatments consisting of either acupuncture or touch-related therapies (reflexology, Shiatsu, Tuina, etc.) with the goal of relieving their symptoms. Patients will be allocated to one of the two study treatment arms: the "Patient-Preference Arm", for patients who specify their preference for either acupuncture or touch therapy; and the "Randomized Treatment Arm", for those with no preference, to be randomly allocated to either the acupuncture or touch-therapy subgroup. Patients will be asked to complete the following study questionnaires before and after the treatment regimen: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30); the Edmonton Symptom Assessment System (ESAS); and the Measure Yourself Concerns and Wellbeing (MYCAW) tool. The primary study outcome will be the change in EORTC Global Health-Status / Quality of Life scores, from pre- to post-treatment. Secondary study outcomes will include EORTC QLQ-C30 functional and symptom scales, single items assessing additional symptoms commonly reported by cancer patients, and perceived financial impact of the disease; ESAS severity scores for 10 quality-of life related items; and MYCAW severity scores for the 2 most significant symptoms, as well as post-treatment narratives. Other secondary outcomes to be assessed include the safety of the study treatments (adverse effects); adherence to conventional treatment regimen; and narratives from the patient's informal caregiver (spouse, parent/child, sibling, friend, etc.).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age ≥ 18 years
undergoing active oncology treatment
fully understand the study plan
agree to sign the study informed consent form.
Disqualifiers
not fulfilling all of the study criteria
not interested in attending all 8 weekly CIM treatments sessions
Trial design
Parallel
Treatments tested in this trial
Acupuncture
Other interventionAcupuncture points will be selected on an individualized and symptom-directed basis, with the incorporation of points shown in clinical research to be effective for specific symptoms
Touch Therapies
Other interventionTouch therapies are to include Reflexology, Shiatsu and Therapeutic Touch
Treatment groups
Trial outcomes
Primary outcomes
EORTC QLQ-C30 global health status / QoL scale
Change from baseline to the end of the 8-week integrative treatment program
Secondary outcomes
EORTC QLQ-C30 global health status / QoL scale
Change from baseline and 8-week assessment to 16 week follow-up
EORTC QLQ-C30 - additional outcomes
Change in functional and symptom scores
ESAS symptom severity scores
Change in severity scores for 10 quality-of life related items
MYCAW symptom severity scores
Change in severity scores for the 2 most significant symptoms, as well as post-treatment narratives
Sponsors and contacts
Click on the lead sponsor to view all of their trials.