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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCarmel Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • acupressure/relaxation with acupuncture

    Other intervention

    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 intervention

    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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Integrative medicine single-modalityExperimental treatment 1 intervention
Group B: Integrative medicine multi-modalityExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Before and immediately following the integrative medicine intervention; at 24-48 hours; and three weeks post-treatment.
2

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.

Time frame
During the 30 minutes integrative medicine intervention

Secondary outcomes

1

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).

Time frame
Before and immediately following the integrative medicine intervention; at 24-48 hours; and three weeks post-treatment.
2

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).

Time frame
Before and three weeks post-treatment.

Other outcomes

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