Integrative Oncology for Patient Symptoms

Not Applicable

Recruiting

• Conditions: Oncologic Complications; Symptoms and Signs
• Interventions: Other: Acupuncture; Other: Touch Therapies

• Registration Number: NCT04940780
• Lead Sponsor: Shaare Zedek Medical Center

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.).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-16
• Study First Submitted QC: 2021-06-23
• Study First Posted: 2021-06-28
• Study Start: 2021-11-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-24
• Primary Completion: 2024-07-31
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 750

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient Preference Arm	Touch Therapies	patients who specify their preference for either acupuncture or touch therapy
Randomized Treatment Arm	Touch Therapies	with no preference, to be randomly allocated to either the acupuncture or touch-therapy subgroup
Randomized Treatment Arm	Acupuncture	with no preference, to be randomly allocated to either the acupuncture or touch-therapy subgroup
Patient Preference Arm	Acupuncture	patients who specify their preference for either acupuncture or touch therapy

Primary Outcome Measures

Name	Time	Method
EORTC QLQ-C30 global health status / QoL scale	8 weeks	Change from baseline to the end of the 8-week integrative treatment program

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institute of Oncology, Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel