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

NCT ID: NCT06604455

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-28
• Study Completion Date: 2026-06-30

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' 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 .

Conditions

Supportive Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Integrative medicine single-modality

Acupressure/relaxation only

Group Type: EXPERIMENTAL

acupressure/relaxation

Intervention Type: 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 multi-modality

Acupressure/relaxation with acupuncture

Group Type: EXPERIMENTAL

acupressure/relaxation with acupuncture

Intervention Type: 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.

Interventions

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 quality of life related concerns, with the option of including breathing and guided imagery modalities as well.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carmel Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Eran Ben-Arye

Director, Integrative Oncology Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eran Ben-Arye, MD

Role: PRINCIPAL_INVESTIGATOR

Director, Integrative Oncology Program

Locations

Carmel Medical center

Haifa, Israel, Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Eran Ben-Arye, MD

Role: CONTACT

ERANBE@clalit.org.il

+972528709282

Orit Gressel, MD

Role: CONTACT

oritgresselraz@gmail.com

+972544947038

Facility Contacts

Eran Ben-Arye, MD

Role: primary

eranbe@clalit.org.il

972528709282

Orit Gressel, MD

Role: backup

oritgresselraz@gmail.com

972544947038

Sameer Kassem, MD

Role: backup

References

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.

Reference Type: BACKGROUND

PMID: 38894501 (View on PubMed)

Other Identifiers

CMC-24-0046

Identifier Type: -

Identifier Source: org_study_id