Impact of Acupuncture and Integrative Medicine on Patients Quality-of-life During National Emergency and Wartime

Impact of Acupuncture and Integrative Medicine on Patients' Quality-of-life During National Emergency and Wartime in Integrative Oncology and Inpatient Settings

The current ongoing war in Israel, which began in October 2023 with a risk for spreading regionally across the Middle East, has presented a significant challenge to many patients, affecting also those receiving active oncology treatment. The present study examines a unique setting of care involving a diverse population of patients, including those receiving oncology treatment, from a widely diverse social, cultural and religious, background. Patients are offered integrative medicine treatments for 3 weeks with the goal of addressing war-related physical, emotional, and other quality of life-related concerns. After signing the informed consent form, patients will be randomly allocated to one of the two study interventions: acupressure-relaxation alone (Group A); or acupressure-relaxation modalities with acupuncture (Group B). The response to the study intervention for quality of life-related concerns will be re-assessed immediately; at 24-48 hours; and after 3 weeks following the treatment. Patients will also undergo objective measurements during treatment using Heart Rate Variability (HRV) to determine the impact of the intervention on their QoL and concerns.

Study Overview

• Status: Recruiting
• Conditions: Supportive Care
• Intervention / Treatment: Other: acupressure/relaxation; Other: acupressure/relaxation with acupuncture

Detailed Description

Integrative medicine is increasingly being included in supportive and palliative care, primarily in oncology settings. The current military conflict in Israel has led to a surge in cases of emotional and physical distress, overwhelming the health profession throughout the country.

Study objectives and purpose: The primary study objective is to improve patients' QoL-related concerns including those affected by the military conflict.

Study design and setting: The study is taken place within a prospective randomized controlled methodology.

Study population: Patients of either gender, hospitalized for various indications (oncology or not) or undergoing out-patient oncology treatment, age ≥ 18 years.

Allocation to study arms and groups: Participants will be randomly assigned using the "Research Randomizer" online tool (https://www.randomizer.org/) to one of the following study groups:

• Single-modality integrative medicine, receiving acupressure/relaxation only (Group A)
• Multi-modality integrative medicine receiving acupressure/relaxation with acupuncture (Group B) In both study groups, the interviews will address quality of life-related concerns, including war-related concerns. Reassessment of these concerns will be conducted immediately post-treatment, 24-hour post treatment and following 3 weeks. patients in both groups will be offered weekly integrative medicine treatments during the 3 weeks following the first treatment .

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eran Ben-Arye, MD; Phone Number: +972528709282; Email: ERANBE@clalit.org.il
• Study Contact Backup: Name: Orit Gressel, MD; Phone Number: +972544947038; Email: oritgresselraz@gmail.com

Study Locations

• Israel
  • Haifa, Israel, 35152
    • Recruiting
    • Carmel Medical Center
    • Contact: Eran Ben-Arye, MD; Phone Number: 972528709282; Email: eranbe@clalit.org.il
    • Contact: Orit Gressel, MD; Phone Number: 972544947038; Email: oritgresselraz@gmail.com
    • Contact: Sameer Kassem, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients diagnosed with cancer, age ≥ 18 years who are either hospitalized or undergoing oncology treatment in an outpatient care setting; or hospitalized for any other diagnosis
• Patients expressing quality of life related concerns affected directly or indirectly to the war and related security status.

Exclusion Criteria:

Inability to read and provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Integrative medicine single-modality; Acupressure/relaxation only	Other: acupressure/relaxation; The acupressure points will be designated based on evidence-based research. In both intervention groups, relaxation techniques will be tailored to the patient's quality of life related concerns, with the option of including breathing and guided imagery modalities as well.
Experimental: Integrative medicine multi-modality; Acupressure/relaxation with acupuncture	Other: acupressure/relaxation with acupuncture; The acupressure/acupuncture points will be designated based on evidence-based research. For example, clinical guideline-based integrative oncology protocol for pain relief will include the following analgesia-related acupressure/acupuncture points: Liver-3, Taichong; Large-Intestine 4, Hegu; Stomach-36, Zusanli; Pericard-6, Neiguan; Spleen-6, Sanyinjiao; Yin tang; as well as battlefield ear acupuncture points. In both intervention groups, relaxation techniques will be tailored to the patient's quality of life related concerns, with the option of including breathing and guided imagery modalities as well.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing patients' quality of life-related concerns using the Measure Yourself Concerns and Wellbeing (MYCAW)	In MYCAW, patients are asked to list and then score (from 0 to 6; 6 is most severe) their 2 most severe quality of life-related concerns	Before and immediately following the integrative medicine intervention; at 24-48 hours; and three weeks post-treatment.
Assessment of objective physiological changes during the intervention	Assessment of objective physiological changes during the 30-minute integrative medicine intervention will be conducted using chest-lead electrocardiogram monitoring autonomic heart rate variability (HRV) throughout.	During the 30 minutes integrative medicine intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing patients' QoL-related concerns using the Edmonton Symptom Assessment Scale (ESAS)	ESAS asks respondents to score a list of 10 QoL-related concerns on a scale from 0 (no symptom) to 10 (worst severity of the symptom).	Before and immediately following the integrative medicine intervention; at 24-48 hours; and three weeks post-treatment.
Assessing patients' quality of life-related concerns using the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30)	EORTC QLQ C-30 asks a number of quality of life-related clusters of concerns, from 1 (not at all) to 4 (very much).	Before and three weeks post-treatment.

Collaborators and Investigators

• Sponsor: Carmel Medical Center
• Investigators: Principal Investigator: Eran Ben-Arye, MD, Director, Integrative Oncology Program

Publications and helpful links

General Publications

• Sowan W, Baziliansky S. Acute Stress Symptoms, Intolerance of Uncertainty and Coping Strategies in Reaction to the October 7 War. Clin Psychol Psychother. 2024 May-Jun;31(3):e3021. doi: 10.1002/cpp.3021.

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: September 17, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: acupuncture; Integrative medicine; Integrative oncology
• Other Study ID Numbers: CMC-24-0046

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
• product manufactured in and exported from the U.S.: No