Clinical trial NCT04940780: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oncologic Complications
Symptoms and Signs
Keywords: Integrative medicine
Integrative oncology
Acupuncture
Touch therapy
Wellbeing
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient-preference, pragmatic methodology
Primary purpose: TREATMENT

Brief summary: 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: 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

Primary outcomes:
measure: EORTC QLQ-C30 global health status / QoL scale
timeFrame: 8 weeks
Secondary outcomes:
measure: EORTC QLQ-C30 global health status / QoL scale
timeFrame: 16 weeks
measure: EORTC QLQ-C30 - additional outcomes
timeFrame: From baseline to 8- (end of treatment program) and 16-week (post-program) assessment
measure: ESAS symptom severity scores
timeFrame: From baseline to 8- (end of treatment program) and 16-week (post-program) assessment
measure: MYCAW symptom severity scores
timeFrame: From baseline to 8- (end of treatment program) and 16-week (post-program) assessment
measure: Frequency of adverse effects
timeFrame: At the end of the series of 8 weekly CIM treatment sessions (≤ 2 weeks after the last treatment session); after 16 weeks from baseline.
measure: Adherence to conventional oncology treatment regimen
timeFrame: At 16 weeks from baseline.
measure: Caregiver expectations
timeFrame: At baseline
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Institute of Oncology, Shaare Zedek Medical Center
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.