Integrative Care Training Program for Nurses on Supportive Cancer Care

Sponsor
Carmel Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03676153
Collaborator
(none)
363
1
2
40.1
9

Study Details

Study Description

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
  • Other: Nurse-provided guidance
  • Other: Integrative medicine treatment program
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
363 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.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
Actual Study Start Date :
Nov 15, 2018
Actual Primary Completion Date :
Feb 1, 2022
Actual Study Completion Date :
Mar 20, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Measure Yourself Concerns and Wellbeing (MYCAW) [48 hours]

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

Secondary Outcome Measures

  1. Edmonton Symptom Assessment Scale (ESAS) [24 hours]

    Scale from 0 (no symptom) to 10 (worst possible symptom)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lin Medical Center Haifa Israel 3515209

Sponsors and Collaborators

  • Carmel Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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
Other Study ID Numbers:
  • CMC-18-0139-CTIL
First Posted:
Sep 18, 2018
Last Update Posted:
Mar 22, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
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, Medical Director, Integrative Oncology Program, Oncology Service, Lin and Carmel Medical Centers, Carmel Medical Center

Study Results

No Results Posted as of Mar 22, 2022