Integrative Oncology for Patient Symptoms

Official title

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

Overview

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.).

Interventions

• Other Acupuncture
  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
• Other Touch Therapies
  Touch therapies are to include Reflexology, Shiatsu and Therapeutic Touch

Primary outcome measures

• EORTC QLQ-C30 global health status / QoL scale [Time frame: 8 weeks]

Secondary outcome measures (7)

• EORTC QLQ-C30 global health status / QoL scale [Time frame: 16 weeks]
• EORTC QLQ-C30 - additional outcomes [Time frame: From baseline to 8- (end of treatment program) and 16-week (post-program) assessment]
• ESAS symptom severity scores [Time frame: From baseline to 8- (end of treatment program) and 16-week (post-program) assessment]
• MYCAW symptom severity scores [Time frame: From baseline to 8- (end of treatment program) and 16-week (post-program) assessment]
• Frequency of adverse effects [Time frame: 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 [Time frame: At 16 weeks from baseline.]
• Caregiver expectations [Time frame: At baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Israel · 1 center

• Institute of Oncology, Shaare Zedek Medical Center — Jerusalem

Publications

• Samuels N, Oberbaum M, Ben-Arye E. Expectations of Patients and Their Informal Caregivers from an Integrative Oncology Consultation. Integr Cancer Ther. 2021 Jan-Dec;20:1534735421990080. doi: 10.1177/1534735421990080. PMID 33588610
• Samuels N, Ben-Arye E. Integrative Approaches to Chemotherapy-Induced Peripheral Neuropathy. Curr Oncol Rep. 2020 Feb 11;22(3):23. doi: 10.1007/s11912-020-0891-2. PMID 32048067
• Ben-Arye E, Dahly H, Keshet Y, Dagash J, Samuels N. Providing integrative care in the pre-chemotherapy setting: a pragmatic controlled patient-centered trial with implications for supportive cancer care. J Cancer Res Clin Oncol. 2018 Sep;144(9):1825-1833. doi: 10.1007/s00432-018-2700-y. Epub 2018 Jul 6. PMID 29980837

Identifiers

NCT: NCT04940780 · INTEGR.ONCOL.REGIST-2021

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗