Clinical trial NCT06604455: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Supportive Care
Keywords: Integrative medicine
Integrative oncology
acupuncture
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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\&#39; 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 .

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

Primary outcomes:
measure: Assessing patients&#39; quality of life-related concerns using the Measure Yourself Concerns and Wellbeing (MYCAW)
timeFrame: Before and immediately following the integrative medicine intervention; at 24-48 hours; and three weeks post-treatment.
measure: Assessment of objective physiological changes during the intervention
timeFrame: During the 30 minutes integrative medicine intervention
Secondary outcomes:
measure: Assessing patients&#39; QoL-related concerns using the Edmonton Symptom Assessment Scale (ESAS)
timeFrame: Before and immediately following the integrative medicine intervention; at 24-48 hours; and three weeks post-treatment.
measure: Assessing patients&#39; quality of life-related concerns using the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30)
timeFrame: Before and three weeks post-treatment.
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical center
Study officials:
affiliation: Director, Integrative Oncology Program
name: Eran Ben-Arye, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.