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

Official title

Impact of Acupuncture and Integrative Medicine on Patients&Amp;Amp;#39; Quality-of-life During National Emergency and Wartime in Integrative Oncology and Inpatient Settings

Overview

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.

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 .

Interventions

• 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 q
• 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.

Primary outcome measures

• Assessing patients' quality of life-related concerns using the Measure Yourself Concerns and Wellbeing (MYCAW) [Time frame: 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 [Time frame: During the 30 minutes integrative medicine intervention]

Secondary outcome measures (2)

• Assessing patients' QoL-related concerns using the Edmonton Symptom Assessment Scale (ESAS) [Time frame: 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) [Time frame: Before and three weeks post-treatment.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Israel · 1 center

• Carmel Medical center — Haifa

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. PMID 38894501
• Ben-Arye E, Gressel O, Keshet Y, Vagedes J, Samuels N, Schachter V, Galil G, Schmidt M, Kassem S. Chemotherapy Under Fire: Narratives of Patients With Cancer During Wartime. Psychooncology. 2025 Nov;34(11):e70327. doi: 10.1002/pon.70327. PMID 41192952

Identifiers

NCT: NCT06604455 · CMC-24-0046

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗