NCT03676153

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
363

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

November 15, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2022

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

3.2 years

First QC Date

September 13, 2018

Last Update Submit

March 20, 2022

Conditions

CancerQuality of LifeNurse's Role

Keywords

Integrative medicineSupportive and Palliative care

Outcome Measures

Primary Outcomes (1)

  • Measure Yourself Concerns and Wellbeing (MYCAW)

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

    48 hours

Secondary Outcomes (1)

  • Edmonton Symptom Assessment Scale (ESAS)

    24 hours

Study Arms (2)

Nurse-guided arm

EXPERIMENTAL

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 guidanceOther: Integrative medicine treatment program

Non nurse-guided arm

ACTIVE COMPARATOR

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

Interventions

Nurse-provided guidanceOTHER

Nurse-provided guidance following an integrative medicine treatment program, for patient implementation of self-administered manual therapies, relaxation, lifestyle changes and traditional medicine.

Nurse-guided arm
Integrative medicine treatment programOTHER

Integrative medicine treatment program

Non nurse-guided armNurse-guided arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Oncology patients undergoing treatment within an adjuvant, neo-adjuvant, curative or palliative setting.

You may not qualify if:

  • Patients who are unable to sign informed consent
  • Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lin Medical Center

Haifa, 3515209, Israel

Location

Related Publications (2)

  • 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.

    PMID: 28632238BACKGROUND

  • 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.

    PMID: 36690415DERIVED

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Pragmatic study examining the impact of a nurse-guided self-administered integrative medicine intervention on quality-of-life outcomes in cancer care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director, Integrative Oncology Program, Oncology Service, Lin and Carmel Medical Centers

Study Record Dates

First Submitted

September 13, 2018

First Posted

September 18, 2018

Study Start

November 15, 2018

Primary Completion

February 1, 2022

Study Completion

March 20, 2022

Last Updated

March 22, 2022

Record last verified: 2022-03

Locations

IL(1)