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Clinical Trials/NCT03676153
NCT03676153
Completed
Not Applicable

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

Carmel Medical Center1 site in 1 country363 target enrollmentNovember 15, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Carmel Medical Center
Enrollment
363
Locations
1
Primary Endpoint
Measure Yourself Concerns and Wellbeing (MYCAW)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
November 15, 2018
End Date
March 20, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Carmel Medical Center
Responsible Party
Principal Investigator
Principal Investigator

Eran Ben-Arye

Medical Director, Integrative Oncology Program, Oncology Service, Lin and Carmel Medical Centers

Carmel Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Measure Yourself Concerns and Wellbeing (MYCAW)

Time Frame: 48 hours

Scale from 0 (not bothering me at all) to 6 (bothers me greatly)

Secondary Outcomes

  • Edmonton Symptom Assessment Scale (ESAS)(24 hours)

Study Sites (1)

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