Behaviors and Mental Disorders

All Conditions

Quality of Life

patients who specify their preference for either acupuncture or touch therapy

with no preference, to be randomly allocated to either the acupuncture or touch-therapy subgroup

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

Acupuncture

Touch therapies are to include Reflexology, Shiatsu and Therapeutic Touch

Touch Therapies

Noah Samuels, M.D.

Nathan Cherny, M.D.

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.).

Patient-preference, pragmatic methodology

Integrative Oncology for Patient Symptoms

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

Change from baseline to the end of the 8-week integrative treatment program

Change from baseline and 8-week assessment to 16 week follow-up

Change in severity scores for 10 quality-of life related items

Change in severity scores for the 2 most significant symptoms, as well as post-treatment narratives

Any reported adverse events taking place during the study period which are considered to have possibly/probably resulted from the CIM intervention

Adherence to oncology treatment to be measured using the Relative Dose Intensity (RDI) calculation

Narratives from the patient's informal caregiver (spouse, parent/child, sibling, friend, etc.).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Integrative Oncology for Patient Symptoms	NCT04940780	Oncologic Compl... Symptoms and Si...	Acupuncture Touch Therapies	18 Years -	Shaare Zedek Medical Center
Integrative Oncology for Patient Symptoms	NCT04940780	Oncologic Compl... Symptoms and Si...	Acupuncture Touch Therapies	18 Years -	Shaare Zedek Medical Center

Spots Global Cancer Trial Database for touch therapies