Integrative Oncology for Patient Symptoms

April 23, 2026 updated by: Noah Samuels, Shaare Zedek Medical Center

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

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.).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

750

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Jerusalem, Israel, 7791031
        • Recruiting
        • Institute of Oncology, Shaare Zedek Medical Center
        • Contact:
        • Sub-Investigator:
          • Nathan Cherny, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patient Preference Arm - Acupuncture
Patients who specify their preference for acupuncture
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
Active Comparator: Randomized Treatment Arm - Acupuncture
Patients with no preference to be randomly allocated to acupuncture (vs. touch-therapy); ratio 1:1
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
Active Comparator: Patient Preference Arm - Touch Therapy
Patients who specify their preference for touch therapy
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
Active Comparator: Randomized Treatment Arm - Touch Therapy
Patients with no preference to be randomly allocated to touch therapy (vs. acupuncture); ratio 1:1
Other: Touch Therapies
Touch therapies are to include Reflexology, Shiatsu and Therapeutic Touch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EORTC QLQ-C30 global health status / QoL scale
Time Frame: 8 weeks
Change from baseline to the end of the 8-week integrative treatment program
8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaare Zedek Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

June 16, 2021

First Submitted That Met QC Criteria

June 23, 2021

First Posted (Actual)

June 28, 2021

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INTEGR.ONCOL.REGIST-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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