OncologyNCT06590766
Impact of Acupuncture and Manual Therapies on Patients' Quality-of-life in a Hospital-to-community Continuum
A study testing acupressure/relaxation with acupuncture in people with Oncology, run by Carmel Medical Center at 1 site in Israel.
Trial summary
Oncology patients often suffer during hospitalization from pain, emotional distress, gastrointestinal symptoms, weakness, and quality of life (QoL)-related concerns. A large body of research has shown that acupuncture and other integrative oncology (IO) modalities, when provided in conjunction with supportive care… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Oncology
- What is being tested?
- acupressure/relaxation with acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteIsrael
- Study dates
- 18 Apr 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with cancer, age ≥ 18 years and hospitalized in one of the six internal medicine and surgical departments in the hospital.
Who cannot join
- Inability to read and provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Carmel Medical center
Haifa, Israel, 35152
Eran Ben-Arye, MD, 972528709282 ext. 0, eranbe@clalit.org.il
Eran Ben-Arye
About this study
Official title: Impact of Acupuncture and Manual Therapies on Patients' Quality-of-life in a Hospital-to-community Continuum of Integrative Oncology and Supportive-palliative Care
Oncology patients often suffer during hospitalization from pain, emotional distress, gastrointestinal symptoms, weakness, and quality of life (QoL)-related concerns. A large body of research has shown that acupuncture and other integrative oncology (IO) modalities, when provided in conjunction with supportive care, can significantly address and alleviate QoL-related concerns. In the proposed study, we examine an innovative model of IO and palliative care, provided to patients with cancer during hospitalization. Oncology patients at the Carmel Medical Center, Haifa, Israel, will be referred by hospital to IO/palliative care, specifying the patient's QoL-related concerns. After signing the informed consent form, patients will be asked to choose between IO intervention (Group A and B) or palliative nursing counseling only (Group C). Patients choosing to undergo integrative treatment 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 QoL-related concerns will be re-assessed immediately; at 24-48 hours; and after 2 weeks following the treatment. Patients will also undergo objective measurements during treatment using Heart Rate Variability (HRV) and Nociception Levels (NOL) to determine the impact of the intervention on their QoL and concerns. In summary, the proposed study will examine the short-term impact of an integrative/palliative intervention on patient QoL-related concerns, comparing acupressure-relaxation modalities with or without acupuncture, as well as to patients receiving palliative nursing counseling. Following discharge, treatments will be provided at one of six participating community IO services, over a 12-week period, in coordination with the oncology and palliative care teams in the community.
Read the detailed description
Scientific background: The provision of complementary and integrative medicine therapies within supportive and palliative oncology care (herewith, Integrative Oncology, IO) is increasingly taking place in leading oncology centers across the globe. The Society for Integrative Oncology (SIO) and the American Society of Clinical Oncology (ASCO) have co-published clinical practice guidelines on the effective and safe use of these modalities for patients with cancer. The proposed study will explore the provision of IO care to patients with cancer during hospitalization, with the goal of addressing emotional distress, pain, fatigue, gastro-intestinal symptoms, and other quality of life (QoL)-related concerns.
Study objectives and purpose: The primary study objective is to improve patients' QoL-related concerns while hospitalized for a variety of cancer-related indications. This, in a clinical context in which in-patient IO interventions are provided together with palliative care, with the two teams coordinating their work. Secondary objective is to identify barriers and enablers to the continuity of IO care, following hospitalization, for patients with cancer, from the in-patient hospital to the out-patient community care setting.
Methods: Study design and setting: The proposed study will take place within a prospective randomized controlled methodology, beginning with a patient-preference stage, in which patients are asked to choose whether they are interested in undergoing IO treatments or palliative nursing counseling.
Study population: Patients of either gender, diagnosed with cancer, age ≥ 18 years and hospitalized in one of the five surgical/internal departments will be eligible for study inclusion. Participating patients will be referred to the study team by a medical healthcare provider in their respective departments, providing a list of clinical indications for the referral.
Allocation to study arms and groups:
Participants will be allocated to one of the two primary study arms, based on their preference for undergoing IO treatments:
- Integrative oncology (IO) arm (Groups A and B): Patients choosing to undergo IO treatments, in addition to standard palliative care
- Palliative nursing counseling (Group C): Patients choosing to undergo a palliative nursing consultation only.
Patients choosing to receive IO care will then be randomly and openly assigned to one of the intervention groups, using the "Research Randomizer" online tool (https://www.randomizer.org/), to one of the following study groups:
- Single-modality IO, receiving acupressure/relaxation only (Group A)
- Multi-modality IO receiving acupressure/relaxation with acupuncture (Group B) IO treatments and palliative nursing consultation: Patients in the intervention arm of the study (groups A and B) will be interviewed and assessed by the IO practitioner, while a palliative nurse specialist will interview those choosing the palliative nursing consultation (Group C). In all study groups, the interviews will address QoL-related concerns, identifying the patient's leading concern (e.g., pain, anxiety). Following the QOL assessment in both groups, an integrative or palliative intervention with the goal of alleviating the patient's leading QoL-related concerns over the next 24-hour period.
Patients in the IO intervention arm of the study will undergo acupressure/relaxation treatments only (Single Modality, Group A), or with the addition of acupuncture (Multi-Modality, Group B). The acupressure/acupuncture points will be designated according to a protocol for each of the four leading concerns (pain, fatigue, emotional, and gastrointestinal), based on evidence-based research. The palliative nursing intervention (Group C) will entail a personalized bio-psycho-social-oriented discussion, highlighting the patient's and their informal caregiver's unmet needs and QoL-related concerns.
- Conditions
- Oncology
- Being tested
- acupressure/relaxation with acupuncture
- Keywords
- Integrative oncology, Palliative care, Acupuncture
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupressure/relaxation with acupunctureOther
Also called Manual and mind-body therapies
The acupressure/acupuncture points will be designated according to a protocol for each of the four leading concerns (pain, fatigue, emotional, and gastrointestinal), based on evidence-based research. For example, clinical guideline-based IO protocols 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 IO intervention groups, relaxation techniques will be tailored to the patient's main concern, with the option of including breathing and guided imagery modalities as well.
| Study group | Role | What they receive |
|---|---|---|
| Integrative oncology single-modality | Experimental | Acupressure/relaxation only Receives: Other: acupressure/relaxation with acupuncture |
| Integrative oncology multi-modality | Experimental | Acupressure/relaxation with acupuncture Receives: Other: acupressure/relaxation with acupuncture |
| Palliative nursing counseling | Active comparator | Patients choosing to undergo a palliative nursing consultation only. 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' QoL-related concerns will be performed using the Edmonton Symptom Assessment Scale (ESAS)
Assessing the effectiveness and safety of an IO intervention involving acupressure and relaxation, either with or without the addition of acupuncture, on the severity of QoL-related concerns among hospitalized oncology patients. Of the three PROMs, 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 IO intervention; at 24-48 hours; and two weeks post-treatment.
Assessing patients' QoL-related concerns will be performed using the Measure Yourself Concerns and Wellbeing (MYCAW).
Of the three PROMs used to assess patients' QoL, in MYCAW, patients to list and then score (from 0 to 6; 6 is most severe) their 2 most severe QoL-related concerns.
Measured: Before and immediately following the IO intervention; at 24-48 hours; and two weeks post-treatment.
Assessing patients' QoL-related concerns will be performed using the European Organization for Research and Treatment of Cancer Quality of Life(EORTC QLQ-C30).
EORTC QLQ C-30 asks a number of QoL-related clusters of concerns, from 1 (not at all) to 4 (very much).
Measured: Before and immediately following the IO intervention; at 24-48 hours; and two weeks post-treatment.
Assessment of objective physiological changes during the intervention
Assessment of objective physiological changes during the 30-minute intervention will be conducted using chest-lead electrocardiogram monitoring autonomic heart rate variability (HRV) throughout. At the same time, nociceptive levels (NOL) will be monitored using a PMD-200 device (Medasense, Ramat Gan, Israel).
Measured: During the 30 minutes intervention
Secondary outcomes (2)
Identifying the most commonly reported QoL-related concerns of hospitalized oncology patients. This based on the Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire.
Identify and evaluating the most commonly reported QoL-related concerns of patients during hospitalization and the indications for which the hospital staff refer them to the IO treatment program. In MYCAW, patients to list and then score (from 0 to 6; 6 is most severe) their 2 most severe QoL-related concerns. In addition to quantitative assessment of patient concerns, a qualitative assessment will be performed using the MYCAW narratives as reported by patients following open-ended questions.
Measured: Before and immediately following the 30-minute intervention.
Identifying barriers and enablers to the continuity of integrative oncology care.This based on the Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire.
Identifying barriers and enablers to the continuity of integrative oncology care for patients with cancer, from the in-patient hospital to the out-patient community care setting. MYCAW questionnaire include also a qualitative segment where patients are asked to report on their feedback and experience following treatment.
Measured: Two weeks for patients with localized cancer; 12 weeks for patients with advanced cancer
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 start18 Apr 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OncologyStudies 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
- 520 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590766
- Sponsor's protocol ID
- CMC-23-0004
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 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
Mao JJ, Ismaila N, Bao T, Barton D, Ben-Arye E, Garland EL, Greenlee H, Leblanc T, Lee RT, Lopez AM, Loprinzi C, Lyman GH, MacLeod J, Master VA, Ramchandran K, Wagner LI, Walker EM, Bruner DW, Witt CM, Bruera E. Integrative Medicine for Pain Management in Oncology: Society for Integrative Oncology-ASCO Guideline. J Clin Oncol. 2022 Dec 1;40(34):3998-4024. doi: 10.1200/JCO.22.01357. Epub 2022 Sep 19.
PubMed 36122322Carlson LE, Ismaila N, Addington EL, Asher GN, Atreya C, Balneaves LG, Bradt J, Fuller-Shavel N, Goodman J, Hoffman CJ, Huston A, Mehta A, Paller CJ, Richardson K, Seely D, Siwik CJ, Temel JS, Rowland JH. Integrative Oncology Care of Symptoms of Anxiety and Depression in Adults With Cancer: Society for Integrative Oncology-ASCO Guideline. J Clin Oncol. 2023 Oct 1;41(28):4562-4591. doi: 10.1200/JCO.23.00857. Epub 2023 Aug 15.
PubMed 37582238Bower JE, Lacchetti C, Alici Y, Barton DL, Bruner D, Canin BE, Escalante CP, Ganz PA, Garland SN, Gupta S, Jim H, Ligibel JA, Loh KP, Peppone L, Tripathy D, Yennu S, Zick S, Mustian K. Management of Fatigue in Adult Survivors of Cancer: ASCO-Society for Integrative Oncology Guideline Update. J Clin Oncol. 2024 Jul 10;42(20):2456-2487. doi: 10.1200/JCO.24.00541. Epub 2024 May 16.
PubMed 38754041
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 Manual Therapies on Patients' Quality-of-life in a Hospital-to-community Continuum of Integrative Oncology and Supportive-palliative Care
- ClinicalTrials.gov ID
- NCT06590766
- Acronym / sponsor ID
- CMC-23-0004
- Conditions
- Oncology
- Keywords
- Integrative oncology, Palliative care, Acupuncture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (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.
Oncology patients often suffer during hospitalization from pain, emotional distress, gastrointestinal symptoms, weakness, and quality of life (QoL)-related concerns. A large body of research has shown that acupuncture and other integrative oncology (IO) modalities, when provided in conjunction with supportive care, can significantly address and alleviate QoL-related concerns. In the proposed study, we examine an innovative model of IO and palliative care, provided to patients with cancer during hospitalization. Oncology patients at the Carmel Medical Center, Haifa, Israel, will be referred by hospital to IO/palliative care, specifying the patient's QoL-related concerns. After signing the informed consent form, patients will be asked to choose between IO intervention (Group A and B) or palliative nursing counseling only (Group C). Patients choosing to undergo integrative treatment 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 QoL-related concerns will be re-assessed immediately; at 24-48 hours; and after 2 weeks following the treatment. Patients will also undergo objective measurements during treatment using Heart Rate Variability (HRV) and Nociception Levels (NOL) to determine the impact of the intervention on their QoL and concerns. In summary, the proposed study will examine the short-term impact of an integrative/palliative intervention on patient QoL-related concerns, comparing acupressure-relaxation modalities with or without acupuncture, as well as to patients receiving palliative nursing counseling. Following discharge, treatments will be provided at one of six participating community IO services, over a 12-week period, in coordination with the oncology and palliative care teams in the community.
Detailed description
Scientific background: The provision of complementary and integrative medicine therapies within supportive and palliative oncology care (herewith, Integrative Oncology, IO) is increasingly taking place in leading oncology centers across the globe. The Society for Integrative Oncology (SIO) and the American Society of Clinical Oncology (ASCO) have co-published clinical practice guidelines on the effective and safe use of these modalities for patients with cancer. The proposed study will explore the provision of IO care to patients with cancer during hospitalization, with the goal of addressing emotional distress, pain, fatigue, gastro-intestinal symptoms, and other quality of life (QoL)-related concerns.
Study objectives and purpose: The primary study objective is to improve patients' QoL-related concerns while hospitalized for a variety of cancer-related indications. This, in a clinical context in which in-patient IO interventions are provided together with palliative care, with the two teams coordinating their work. Secondary objective is to identify barriers and enablers to the continuity of IO care, following hospitalization, for patients with cancer, from the in-patient hospital to the out-patient community care setting.
Methods: Study design and setting: The proposed study will take place within a prospective randomized controlled methodology, beginning with a patient-preference stage, in which patients are asked to choose whether they are interested in undergoing IO treatments or palliative nursing counseling.
Study population: Patients of either gender, diagnosed with cancer, age ≥ 18 years and hospitalized in one of the five surgical/internal departments will be eligible for study inclusion. Participating patients will be referred to the study team by a medical healthcare provider in their respective departments, providing a list of clinical indications for the referral.
Allocation to study arms and groups:
Participants will be allocated to one of the two primary study arms, based on their preference for undergoing IO treatments:
- Integrative oncology (IO) arm (Groups A and B): Patients choosing to undergo IO treatments, in addition to standard palliative care
- Palliative nursing counseling (Group C): Patients choosing to undergo a palliative nursing consultation only.
Patients choosing to receive IO care will then be randomly and openly assigned to one of the intervention groups, using the "Research Randomizer" online tool (https://www.randomizer.org/), to one of the following study groups:
- Single-modality IO, receiving acupressure/relaxation only (Group A)
- Multi-modality IO receiving acupressure/relaxation with acupuncture (Group B) IO treatments and palliative nursing consultation: Patients in the intervention arm of the study (groups A and B) will be interviewed and assessed by the IO practitioner, while a palliative nurse specialist will interview those choosing the palliative nursing consultation (Group C). In all study groups, the interviews will address QoL-related concerns, identifying the patient's leading concern (e.g., pain, anxiety). Following the QOL assessment in both groups, an integrative or palliative intervention with the goal of alleviating the patient's leading QoL-related concerns over the next 24-hour period.
Patients in the IO intervention arm of the study will undergo acupressure/relaxation treatments only (Single Modality, Group A), or with the addition of acupuncture (Multi-Modality, Group B). The acupressure/acupuncture points will be designated according to a protocol for each of the four leading concerns (pain, fatigue, emotional, and gastrointestinal), based on evidence-based research. The palliative nursing intervention (Group C) will entail a personalized bio-psycho-social-oriented discussion, highlighting the patient's and their informal caregiver's unmet needs and QoL-related concerns.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Integrative oncology single-modality | Experimental | Other: acupressure/relaxation with acupunctureAcupressure/relaxation only |
| Integrative oncology multi-modality | Experimental | Other: acupressure/relaxation with acupunctureAcupressure/relaxation with acupuncture |
| Palliative nursing counseling | Active comparator | Other: acupressure/relaxation with acupuncturePatients choosing to undergo a palliative nursing consultation only. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with cancer, age ≥ 18 years and hospitalized in one of the six internal medicine and surgical departments in the hospital.
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 acupunctureAlso: Manual and mind-body therapiesThe acupressure/acupuncture points will be designated according to a protocol for each of the four leading concerns (pain, fatigue, emotional, and gastrointestinal), based on evidence-based research. For example, clinical guideline-based IO protocols 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 IO intervention groups, relaxation techniques will be tailored to the patient's main concern, with the option of including breathing and guided imagery modalities as well. | Other | Integrative oncology multi-modality, Integrative oncology single-modality, Palliative nursing counseling |
Primary outcome
Assessing patients' QoL-related concerns will be performed using the Edmonton Symptom Assessment Scale (ESAS)
Time frame: Before and immediately following the IO intervention; at 24-48 hours; and two weeks post-treatment.
Assessing the effectiveness and safety of an IO intervention involving acupressure and relaxation, either with or without the addition of acupuncture, on the severity of QoL-related concerns among hospitalized oncology patients. Of the three PROMs, 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).
Assessing patients' QoL-related concerns will be performed using the Measure Yourself Concerns and Wellbeing (MYCAW).
Time frame: Before and immediately following the IO intervention; at 24-48 hours; and two weeks post-treatment.
Of the three PROMs used to assess patients' QoL, in MYCAW, patients to list and then score (from 0 to 6; 6 is most severe) their 2 most severe QoL-related concerns.
Assessing patients' QoL-related concerns will be performed using the European Organization for Research and Treatment of Cancer Quality of Life(EORTC QLQ-C30).
Time frame: Before and immediately following the IO intervention; at 24-48 hours; and two weeks post-treatment.
EORTC QLQ C-30 asks a number of QoL-related clusters of concerns, from 1 (not at all) to 4 (very much).
Assessment of objective physiological changes during the intervention
Time frame: During the 30 minutes intervention
Assessment of objective physiological changes during the 30-minute intervention will be conducted using chest-lead electrocardiogram monitoring autonomic heart rate variability (HRV) throughout. At the same time, nociceptive levels (NOL) will be monitored using a PMD-200 device (Medasense, Ramat Gan, Israel).
2 secondary outcomes
Identifying the most commonly reported QoL-related concerns of hospitalized oncology patients. This based on the Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire.
Time frame: Before and immediately following the 30-minute intervention.
Identifying barriers and enablers to the continuity of integrative oncology care.This based on the Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire.
Time frame: Two weeks for patients with localized cancer; 12 weeks for patients with advanced cancer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 36122322Mao JJ, Ismaila N, Bao T, Barton D, Ben-Arye E, Garland EL, Greenlee H, Leblanc T, Lee RT, Lopez AM, Loprinzi C, Lyman GH, MacLeod J, Master VA, Ramchandran K, Wagner LI, Walker EM, Bruner DW, Witt CM, Bruera E. Integrative Medicine for Pain Management in Oncology: Society for Integrative Oncology-ASCO Guideline. J Clin Oncol. 2022 Dec 1;40(34):3998-4024. doi: 10.1200/JCO.22.01357. Epub 2022 Sep 19.
- Background: PubMed 37582238Carlson LE, Ismaila N, Addington EL, Asher GN, Atreya C, Balneaves LG, Bradt J, Fuller-Shavel N, Goodman J, Hoffman CJ, Huston A, Mehta A, Paller CJ, Richardson K, Seely D, Siwik CJ, Temel JS, Rowland JH. Integrative Oncology Care of Symptoms of Anxiety and Depression in Adults With Cancer: Society for Integrative Oncology-ASCO Guideline. J Clin Oncol. 2023 Oct 1;41(28):4562-4591. doi: 10.1200/JCO.23.00857. Epub 2023 Aug 15.
- Background: PubMed 38754041Bower JE, Lacchetti C, Alici Y, Barton DL, Bruner D, Canin BE, Escalante CP, Ganz PA, Garland SN, Gupta S, Jim H, Ligibel JA, Loh KP, Peppone L, Tripathy D, Yennu S, Zick S, Mustian K. Management of Fatigue in Adult Survivors of Cancer: ASCO-Society for Integrative Oncology Guideline Update. J Clin Oncol. 2024 Jul 10;42(20):2456-2487. doi: 10.1200/JCO.24.00541. Epub 2024 May 16.
- 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.
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 in people with Oncology, 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 1 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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eran Ben-Arye, MD (+97248568333, 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' QoL-related concerns will be performed using the Edmonton Symptom Assessment Scale (ESAS) (time frame: Before and immediately following the IO intervention; at 24-48 hours; and two weeks post-treatment.). The study lists 4 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 NCT06590766, which also lists 3 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.