Integrative Oncology for Patient Symptoms

Study Overview
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Brief Summary
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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.).

Official Title
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Examining the Impact of an Integrative Oncology Program on Patient Symptoms and Quality of Life: a Prospective Pragmatic Registry Protocol Study

Conditions
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Oncologic Complications, Symptoms and Signs

Intervention / Treatment
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* Other: Acupuncture
* Other: Touch Therapies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 18 years undergoing active oncology treatment fully understand the study plan agree to sign the study informed consent form. Exclusion Criteria: not fulfilling all of the study criteria not interested in attending all 8 weekly CIM treatments sessions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patient-preference, pragmatic methodology
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patient Preference Arm<br>patients who specify their preference for either acupuncture or touch therapy | Other: Acupuncture<br>* Acupuncture 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<br>Other: Touch Therapies<br>* Touch therapies are to include Reflexology, Shiatsu and Therapeutic Touch<br>|
| Active Comparator: Randomized Treatment Arm<br>with no preference, to be randomly allocated to either the acupuncture or touch-therapy subgroup | Other: Acupuncture<br>* Acupuncture 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<br>Other: Touch Therapies<br>* Touch therapies are to include Reflexology, Shiatsu and Therapeutic Touch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EORTC QLQ-C30 global health status / QoL scale | Change from baseline to the end of the 8-week integrative treatment program | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EORTC QLQ-C30 global health status / QoL scale | Change from baseline and 8-week assessment to 16 week follow-up | 16 weeks | 
| EORTC QLQ-C30 - additional outcomes | Change in functional and symptom scores | From baseline to 8- (end of treatment program) and 16-week (post-program) assessment | 
| ESAS symptom severity scores | Change in severity scores for 10 quality-of life related items | From baseline to 8- (end of treatment program) and 16-week (post-program) assessment | 
| MYCAW symptom severity scores | Change in severity scores for the 2 most significant symptoms, as well as post-treatment narratives | From baseline to 8- (end of treatment program) and 16-week (post-program) assessment | 
| Frequency of adverse effects | Any reported adverse events taking place during the study period which are considered to have possibly/probably resulted from the CIM intervention | At the end of the series of 8 weekly CIM treatment sessions (≤ 2 weeks after the last treatment session); after 16 weeks from baseline. | 
| Adherence to conventional oncology treatment regimen | Adherence to oncology treatment to be measured using the Relative Dose Intensity (RDI) calculation | At 16 weeks from baseline. | 
| Caregiver expectations | Narratives from the patient's informal caregiver (spouse, parent/child, sibling, friend, etc.). | At baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Integrative medicine, Integrative oncology, Acupuncture, Touch therapy, Wellbeing