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NCT Number: NCT06604455

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

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.

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Key information

Conditions

Supportive Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

    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

  2. Assessment of objective physiological changes during the intervention

    Time frame: During the 30 minutes integrative medicine 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.

Secondary outcomes

  1. 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.

    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).

  2. 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.

    EORTC QLQ C-30 asks a number of quality of life-related clusters of concerns, from 1 (not at all) to 4 (very much).

Study contacts

Contact information is provided by the study sponsor or research team.

Eran Ben-Arye, MD

CONTACT

[email protected]

+972528709282

Orit Gressel, MD

CONTACT

[email protected]

+972544947038

Sponsors and collaborators

Lead sponsor

Carmel Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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