Supportive CareNCT06604455
Impact of Acupuncture and Integrative Medicine on Patients Quality-of-life During National Emergency and Wartime
A study testing acupressure/relaxation with acupuncture and acupressure/relaxation in people with Supportive Care, run by Carmel Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Supportive Care
- What is being tested?
- acupressure/relaxation with acupuncture and acupressure/relaxation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- 28 Aug 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Inability to read and provide informed consent
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Carmel Medical center
Haifa, Israel, 35152
Eran Ben-Arye, MD, 972528709282, eranbe@clalit.org.il
Orit Gressel, MD, 972544947038, oritgresselraz@gmail.com
About this study
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
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.
Read the 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
- Being tested
- acupressure/relaxation with acupuncture, acupressure/relaxation
- Keywords
- Integrative medicine, Integrative oncology, acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupressure/relaxation with acupunctureOther
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/relaxationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Integrative medicine single-modality | Experimental | Acupressure/relaxation only Receives: Other: acupressure/relaxation |
| Integrative medicine multi-modality | Experimental | Acupressure/relaxation with acupuncture Receives: Other: acupressure/relaxation with acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Before and immediately following the integrative medicine intervention; at 24-48 hours; and three weeks post-treatment.
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.
Measured: During the 30 minutes integrative medicine intervention
Secondary outcomes (2)
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).
Measured: Before and immediately following the integrative medicine intervention; at 24-48 hours; and three weeks post-treatment.
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).
Measured: Before and three weeks post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start28 Aug 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Supportive CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eran Ben-Arye, Carmel Medical Center
- Investigators
- Eran Ben-Arye, MD, Principal investigator, Director, Integrative Oncology Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604455
- Sponsor's protocol ID
- CMC-24-0046
- Status last verified
- Sep 2024
- First submitted
- 17 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38894501Ben-Arye E, Gressel O, Keshet Y, Vagedes J, Samuels N, Schachter V, Galil G, Schmidt M, Kassem S. Chemotherapy Under Fire: Narratives of Patients With Cancer During Wartime. Psychooncology. 2025 Nov;34(11):e70327. doi: 10.1002/pon.70327.
PubMed 41192952
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06604455
- Acronym / sponsor ID
- CMC-24-0046
- Conditions
- Supportive Care
- Keywords
- Integrative medicine, Integrative oncology, acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrative medicine single-modality | Experimental | Other: acupressure/relaxationAcupressure/relaxation only |
| Integrative medicine multi-modality | Experimental | Other: acupressure/relaxation with acupunctureAcupressure/relaxation with acupuncture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Inability to read and provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupressure/relaxation with acupunctureThe 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. | Other | Integrative medicine multi-modality |
| acupressure/relaxationThe 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. | Other | Integrative medicine single-modality |
Primary outcome
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
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.
2 secondary outcomes
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Results publication: PubMed 38894501Sowan 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.
- Derived from this study: PubMed 41192952Ben-Arye E, Gressel O, Keshet Y, Vagedes J, Samuels N, Schachter V, Galil G, Schmidt M, Kassem S. Chemotherapy Under Fire: Narratives of Patients With Cancer During Wartime. Psychooncology. 2025 Nov;34(11):e70327. doi: 10.1002/pon.70327.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eran Ben-Arye, MD principal investigator
Director, Integrative Oncology Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupressure/relaxation with acupuncture and acupressure/relaxation in people with Supportive Care, run by Carmel Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eran Ben-Arye, MD (+972528709282, ERANBE@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06604455, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.