Integrative Care Training Program for Nurses on Supportive Cancer Care
NCT ID: NCT03676153
Last Updated: 2022-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
363 participants
INTERVENTIONAL
2018-11-15
2022-03-20
Brief Summary
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The proposed study will be conducted within a pragmatic, randomized and controlled format, and will examine the impact of a nurse-guided intervention on 540 oncology patients undergoing Integrative Oncology treatments for quality of life (QOL)-related concerns during adjuvant/neo-adjuvant or curative/palliative treatments. Patients in both study arms will undergo patient-tailored integrative treatments, which will include manual and relaxation therapies, acupuncture and lifestyle changes. The integrative treatments will be provided by trained integrative oncology practitioners. Patients in the intervention arm of the study will receive additional nurse-guided instruction in the self-administration of manual therapies, relaxation, lifestyle changes and traditional medicine practices.
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Detailed Description
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The proposed study will be conducted within a pragmatic, randomized and controlled format, and will examine the impact of a nurse-guided intervention on 540 oncology patients undergoing Integrative Oncology treatments for quality of life (QOL)-related concerns during adjuvant/neo-adjuvant or curative/palliative treatments. Patients in both study arms will undergo patient-tailored integrative treatments, which will include manual and relaxation therapies, acupuncture and lifestyle changes. The integrative treatments will be provided by trained integrative oncology practitioners. Patients in the intervention arm of the study will receive additional nurse-guided instruction in the self-administration of manual therapies, relaxation, lifestyle changes and traditional medicine practices.
The primary study outcome will be the assessment of the impact of the integrative treatment (with vs. without the nurse-guided intervention) on patient QOL-related concerns, from baseline to 48 hours following the intervention. For this purpose, two patient-reported outcome measures (PROMs) will be administered: the Edmonton Symptom Assessment Scale (ESAS) and the Measure Yourself Concern and Wellbeing (MYCAW) questionnaire. Secondary outcome measures will include the need for medications for supportive/palliative care-related indications (pain, nausea, anxiety/depression, constipation/diarrhea, etc.); and the rates of referral of patients to the services provided by the supportive/palliative care service.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nurse-guided arm
Nurse-provided guidance following an integrative medicine treatment program, for patient implementation of self-administered manual therapies, relaxation, lifestyle changes and traditional medicine.
Nurse-provided guidance
Nurse-provided guidance following an integrative medicine treatment program, for patient implementation of self-administered manual therapies, relaxation, lifestyle changes and traditional medicine.
Integrative medicine treatment program
Integrative medicine treatment program
Non nurse-guided arm
Integrative medicine treatment program, with no nurse-provided guidance on patient implementation of self-administered manual therapies, relaxation, lifestyle changes and traditional medicine.
Integrative medicine treatment program
Integrative medicine treatment program
Interventions
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Nurse-provided guidance
Nurse-provided guidance following an integrative medicine treatment program, for patient implementation of self-administered manual therapies, relaxation, lifestyle changes and traditional medicine.
Integrative medicine treatment program
Integrative medicine treatment program
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnant patients
18 Years
ALL
No
Sponsors
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Carmel Medical Center
OTHER
Responsible Party
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Eran Ben-Arye
Medical Director, Integrative Oncology Program, Oncology Service, Lin and Carmel Medical Centers
Locations
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Lin Medical Center
Haifa, , Israel
Countries
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References
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Ben-Arye E, Shulman B, Eilon Y, Woitiz R, Cherniak V, Shalom Sharabi I, Sher O, Reches H, Katz Y, Arad M, Schiff E, Samuels N, Caspi O, Lev-Ari S, Frenkel M, Agbarya A, Admi H. Attitudes Among Nurses Toward the Integration of Complementary Medicine Into Supportive Cancer Care. Oncol Nurs Forum. 2017 Jul 1;44(4):428-434. doi: 10.1188/17.ONF.428-434.
Ben-Arye E, Tapiro Y, Baruch R, Tal A, Shulman B, Gressel O, Israeli P, Dagash J, Yosipovich A, Shalom Sharabi I, Zimmermann P, Samuels N. Integrative oncology for palliative care nurses: pre-post training evaluation. BMJ Support Palliat Care. 2024 May 17;14(2):178-182. doi: 10.1136/spcare-2022-004117.
Other Identifiers
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CMC-18-0139-CTIL
Identifier Type: -
Identifier Source: org_study_id
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