Clinical trial · Interventional
Integrative Oncology for Patient Symptoms
Examining the Impact of an Integrative Oncology Program on Patient Symptoms and Quality of Life: a Prospective Pragmatic Registry Protocol Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oncologic Complications | — | UNRESOLVED | — |
| Symptoms and Signs | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acupuncture | Other | — | UNRESOLVED |
| Touch Therapies | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Patient Preference Arm - Acupuncture
- description
- Patients who specify their preference for acupuncture
- interventionNames
- Other: Acupuncture
- Other: Touch Therapies
- type
- ACTIVE_COMPARATOR
- label
- Randomized Treatment Arm - Acupuncture
- description
- Patients with no preference to be randomly allocated to acupuncture (vs. touch-therapy); ratio 1:1
- interventionNames
- Other: Acupuncture
- type
- ACTIVE_COMPARATOR
- label
- Patient Preference Arm - Touch Therapy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDSamuels 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
- BACKGROUNDSamuels 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
- BACKGROUNDBen-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