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

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

NCT ID: NCT06604455

Condition: Supportive Care

Conditions: Keywords:
Integrative medicine
Integrative oncology
acupuncture

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Other
Intervention name: acupressure/relaxation with acupuncture
Description: 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.
Arm group label: Integrative medicine multi-modality

Intervention type: Other
Intervention name: acupressure/relaxation
Description: 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.
Arm group label: Integrative medicine single-modality

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' 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 .

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Carmel Medical center

Address:
City: Haifa
Zip: 35152
Country: Israel

Status: Recruiting

Contact:
Last name: Eran Ben-Arye, MD

Phone: 972528709282
Email: eranbe@clalit.org.il

Contact backup:
Last name: Orit Gressel, MD

Phone: 972544947038
Email: oritgresselraz@gmail.com

Contact backup:
Last name: Sameer Kassem, MD

Start date: August 28, 2024

Completion date: June 30, 2026

Lead sponsor:
Agency: Carmel Medical Center
Agency class: Other

Source: Carmel Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06604455