Integrative Oncology for Patient Symptoms

Symptoms and Signs Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04940780
• Other study ID #: INTEGR.ONCOL.REGIST-2021
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: January 1, 2025

Study information

• Verified date: November 2023
• Source: Shaare Zedek Medical Center
• Contact: Noah Samuels, M.D.
• Phone: 972-26666395
• Email: noahs[@]szmc.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: January 1, 2025
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Oncologic Complications
• Symptoms and Signs

Intervention

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
• Touch Therapies
Touch therapies are to include Reflexology, Shiatsu and Therapeutic Touch

Locations

Country	Name	City	State
Israel	Institute of Oncology, Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EORTC QLQ-C30 global health status / QoL scale	Change from baseline to the end of the 8-week integrative treatment program	8 weeks
Secondary	EORTC QLQ-C30 global health status / QoL scale	Change from baseline and 8-week assessment to 16 week follow-up	16 weeks
Secondary	EORTC QLQ-C30 - additional outcomes	Change in functional and symptom scores	From baseline to 8- (end of treatment program) and 16-week (post-program) assessment
Secondary	ESAS symptom severity scores	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
Secondary	MYCAW symptom severity scores	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
Secondary	Frequency of adverse effects	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.
Secondary	Adherence to conventional oncology treatment regimen	Adherence to oncology treatment to be measured using the Relative Dose Intensity (RDI) calculation	At 16 weeks from baseline.
Secondary	Caregiver expectations	Narratives from the patient's informal caregiver (spouse, parent/child, sibling, friend, etc.).	At baseline