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

NCT06604455 | Recruiting DMC

• 1 other identifier: CMC-24-0046
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Supportive Care

Keywords

Integrative medicine; Integrative oncology; acupuncture

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Assessing patients' QoL-related concerns using the Edmonton Symptom Assessment Scale (ESAS)

  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)

  Before and three weeks post-treatment.

Study Arms (2)

Integrative medicine single-modality

EXPERIMENTAL

Acupressure/relaxation only

Other: acupressure/relaxation

Integrative medicine multi-modality

EXPERIMENTAL

Acupressure/relaxation with acupuncture

Other: acupressure/relaxation with acupuncture

Interventions

acupressure/relaxation with acupuncture OTHER

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.

Integrative medicine multi-modality

acupressure/relaxation OTHER

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.

Integrative medicine single-modality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Inability to read and provide informed consent

Sponsors & Collaborators

• Carmel Medical Center: lead

Study Sites (1)

Carmel Medical center

Haifa, Israel, 35152, Israel

RECRUITING

Related Publications (1)

• 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.

  PMID: 38894501 BACKGROUND

MeSH Terms

Interventions

Acupressure; Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Eran Ben-Arye, MD

  Director, Integrative Oncology Program

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eran Ben-Arye, MD

CONTACT

+972528709282; ERANBE@clalit.org.il

Orit Gressel, MD

CONTACT

+972544947038; oritgresselraz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Integrative Oncology Program

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: August 28, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)