Integrative Care Training Program for Nurses on Supportive Cancer Care

NCT ID: NCT03676153

Last Updated: 2022-03-22

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

363 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-15

Study Completion Date

2022-03-20

Brief Summary

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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

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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.

Conditions

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Cancer Quality of Life Nurse's Role

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pragmatic study examining the impact of a nurse-guided self-administered integrative medicine intervention on quality-of-life outcomes in cancer care.
Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Nurse-provided guidance

Intervention Type OTHER

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

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Integrative medicine treatment program

Intervention Type OTHER

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.

Intervention Type OTHER

Integrative medicine treatment program

Integrative medicine treatment program

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Carmel Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Eran Ben-Arye

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lin Medical Center

Haifa, , Israel

Site Status

Countries

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Israel

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.

Reference Type BACKGROUND
PMID: 28632238 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36690415 (View on PubMed)

Other Identifiers

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CMC-18-0139-CTIL

Identifier Type: -

Identifier Source: org_study_id

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