- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03676153
Integrative Care Training Program for Nurses on Supportive Cancer Care
Assessing the Impact of an Integrative Care Training Program for Nurses in Manual Therapies, Relaxation, Lifestyle Changes and Traditional Medicine on Quality of Life in Oncology Patients: A Randomized Controlled Study
The integration of complementary medicine in supportive and palliative cancer care (i.e., Integrative Oncology) is becoming more prevalent in many of the leading oncology centers in Israel and worldwide. Guidelines for these practices, as established by the Society for Integrative Oncology, were adopted in 2018 by the American Society of Clinical Oncology.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The integration of complementary medicine in supportive and palliative cancer care (i.e., Integrative Oncology) is becoming more prevalent in many of the leading oncology centers in Israel and worldwide. Guidelines for these practices, as established by the Society for Integrative Oncology, were adopted in 2018 by the American Society of Clinical Oncology.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Haifa, Israel, 3515209
- Lin Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Oncology patients undergoing treatment within an adjuvant, neo-adjuvant, curative or palliative setting.
Exclusion Criteria:
- Patients who are unable to sign informed consent
- Pregnant patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 following an integrative medicine treatment program, for patient implementation of self-administered manual therapies, relaxation, lifestyle changes and traditional medicine.
Integrative medicine treatment program
|
Active Comparator: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure Yourself Concerns and Wellbeing (MYCAW)
Time Frame: 48 hours
|
Scale from 0 (not bothering me at all) to 6 (bothers me greatly)
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Edmonton Symptom Assessment Scale (ESAS)
Time Frame: 24 hours
|
Scale from 0 (no symptom) to 10 (worst possible symptom)
|
24 hours
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CMC-18-0139-CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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