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Integrative Care Training Program for Nurses on Supportive Cancer Care

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ClinicalTrials.gov Identifier: NCT03676153
Recruitment Status : Not yet recruiting
First Posted : September 18, 2018
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Eran Ben-Arye, Carmel Medical Center

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.


Condition or disease Intervention/treatment Phase
Cancer Quality of Life Nurse's Role Other: Nurse-provided guidance Other: Integrative medicine treatment program Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pragmatic study examining the impact of a nurse-guided self-administered integrative medicine intervention on quality-of-life outcomes in cancer care.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

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.
Other: 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.

Other: Integrative medicine treatment program
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.
Other: Integrative medicine treatment program
Integrative medicine treatment program




Primary Outcome Measures :
  1. Measure Yourself Concerns and Wellbeing (MYCAW) [ Time Frame: 48 hours ]
    Scale from 0 (not bothering me at all) to 6 (bothers me greatly)


Secondary Outcome Measures :
  1. Edmonton Symptom Assessment Scale (ESAS) [ Time Frame: 24 hours ]
    Scale from 0 (no symptom) to 10 (worst possible symptom)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03676153


Contacts
Contact: Eran Ben-Arye, MD 972-4-8568333 eranben@netvision.net.il

Sponsors and Collaborators
Carmel Medical Center

Publications:
Responsible Party: Eran Ben-Arye, Medical Director, Integrative Oncology Program, Oncology Service, Lin and Carmel Medical Centers, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT03676153     History of Changes
Other Study ID Numbers: CMC-18-0139-CTIL
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eran Ben-Arye, Carmel Medical Center:
Integrative medicine
Supportive and Palliative care