NCT04940780 Integrative Oncology for Patient Symptoms
| NCT ID | NCT04940780 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shaare Zedek Medical Center |
| Condition | Oncologic Complications |
| Study Type | INTERVENTIONAL |
| Enrollment | 750 participants |
| Start Date | 2021-11-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 750 participants in total. It began in 2021-11-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04940780 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oncologic Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04940780 currently recruiting?
Yes, NCT04940780 is actively recruiting participants. Contact the research team at noahs@szmc.org.il for enrollment information.
Where is the NCT04940780 trial being conducted?
This trial is being conducted at Jerusalem, Israel.
Who is sponsoring the NCT04940780 clinical trial?
NCT04940780 is sponsored by Shaare Zedek Medical Center. The trial plans to enroll 750 participants.