Integrative Oncology for Patient Symptoms

NCT04940780 | Recruiting

• 1 other identifier: INTEGR.ONCOL.REGIST-2021
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

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.).

Conditions

Oncologic Complications; Symptoms and Signs

Keywords

Integrative medicine; Integrative oncology; Acupuncture; Touch therapy; Wellbeing

Outcome Measures

Primary Outcomes (1)

• EORTC QLQ-C30 global health status / QoL scale

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

  8 weeks

Secondary Outcomes (7)

• EORTC QLQ-C30 global health status / QoL scale

  16 weeks

• EORTC QLQ-C30 - additional outcomes

  From baseline to 8- (end of treatment program) and 16-week (post-program) assessment

• ESAS symptom severity scores

  From baseline to 8- (end of treatment program) and 16-week (post-program) assessment

• MYCAW symptom severity scores

  From baseline to 8- (end of treatment program) and 16-week (post-program) assessment

• 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.

Study Arms (4)

Patient Preference Arm - Acupuncture

ACTIVE COMPARATOR

Patients who specify their preference for acupuncture

Other: Acupuncture; Other: Touch Therapies

Randomized Treatment Arm - Acupuncture

ACTIVE COMPARATOR

Patients with no preference to be randomly allocated to acupuncture (vs. touch-therapy); ratio 1:1

Other: Acupuncture

Patient Preference Arm - Touch Therapy

ACTIVE COMPARATOR

Patients who specify their preference for touch therapy

Other: Acupuncture; Other: Touch Therapies

Randomized Treatment Arm - Touch Therapy

ACTIVE COMPARATOR

Patients with no preference to be randomly allocated to touch therapy (vs. acupuncture); ratio 1:1

Other: Touch Therapies

Interventions

Acupuncture OTHER

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

Patient Preference Arm - Acupuncture; Patient Preference Arm - Touch Therapy; Randomized Treatment Arm - Acupuncture

Touch Therapies OTHER

Touch therapies are to include Reflexology, Shiatsu and Therapeutic Touch

Patient Preference Arm - Acupuncture; Patient Preference Arm - Touch Therapy; Randomized Treatment Arm - Touch Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years
• undergoing active oncology treatment
• fully understand the study plan
• agree to sign the study informed consent form.

You may not qualify if:

• not fulfilling all of the study criteria
• not interested in attending all 8 weekly CIM treatments sessions

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Institute of Oncology, Shaare Zedek Medical Center

Jerusalem, 7791031, Israel

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Signs and Symptoms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Noah Samuels, M.D.

CONTACT

972-26666395; noahs@szmc.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Integrative Complementary Medicine

Model Details: Patient-preference, pragmatic methodology

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: June 28, 2021
• Study Start: November 1, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)