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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Integrative medicine single-modality | Experimental | Acupressure/relaxation only |
|
| Integrative medicine multi-modality | Experimental | Acupressure/relaxation with acupuncture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Inability to read and provide informed consent
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eran Ben-Arye, MD | Contact | +972528709282 | ERANBE@clalit.org.il | |
| Orit Gressel, MD | Contact | +972544947038 | oritgresselraz@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Eran Ben-Arye, MD | Director, Integrative Oncology Program | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carmel Medical center | Recruiting | Haifa | Israel | 35152 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38894501 | Result | 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. |
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| ID | Term |
|---|---|
| D019050 | Acupressure |
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
| 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. |
|
| 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. |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |