SONICS - Effectiveness of Specialist Oncology Nursing

June 17, 2009 updated by: McMaster University

A Study of the Effectiveness of Specialist Oncology Nursing Case Management in Improving Continuity of Supportive Cancer Care in the Community (SONICS)

This research project will address the issue of gaps in continuity of supportive care for cancer patients during the early phases of the disease trajectory that result in unmet needs and unnecessary morbidity. The investigators intend to study the impact of a specialized cancer-nursing program, Interlink Community Cancer Nurses (Interlink) on patient outcomes. Impact will be assessed directly using a validated measure of continuity of care from the patients' perspective and validated measures of key supportive care patient outcomes including unmet needs, distress, uncertainty in illness, and quality of life, in a randomized trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Behavioral: Community Interlink Program

Detailed Description

Main Research Question: Does community-based specialist oncology nursing case management improve continuity of cancer care and lead to fewer unmet cancer patient needs?

Why this research is important: This research proposal addresses the issue of gaps in continuity of supportive care for cancer patients during the early phases of the disease trajectory that result in unmet needs and unnecessary morbidity, prior to entry into a formalized cancer care system (e.g., a regional cancer centre or hospital with a cancer treatment program). This initial diagnostic period of cancer is associated with significant stress, anxiety and uncertainty that can impact upon overall quality of life for all types of cancer. These problems are further exacerbated by waiting times of up to 16 weeks between diagnosis and attendance in a formalized cancer treatment system. During this time patients will face a fragmented supportive care service system resulting in a substantial number of patients reporting unmet needs and distress. These care gaps have significant implications considering that 38% of women and 41% of men will develop cancer during their lifetime and that cancer incidence continues to rise with an estimated 139,000 new cases in Canada (over 54,000 of these in Ontario) in 2003. There has been growing interest in nursing models to address these gaps in supportive cancer care but at this time there is not sufficient high quality evidence upon which to base policy decisions to support the widespread introduction of this type of model. The results of this study will be very important for policy development for community cancer care in Ontario and in other provinces in Canada.

What is being studied: We will study the impact of a specialized nursing intervention (Interlink) on patient outcomes early in the disease trajectory. Impact will be assessed directly using validated measures in a randomized controlled trial design. These measures will include: continuity of care, unmet needs, psychological distress, uncertainty in illness, and quality of life.

Study Type

Interventional

Enrollment (Actual)

183

Phase

Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Histologically confirmed breast or colorectal cancer.
In the initial stages of surgical consultation within the randomized surgical practices.
Not had previous or concomitant malignancies (except for: non-melanoma skin cancer, or carcinoma in situ of the cervix).
Have been informed of cancer diagnosis by the surgical office.
Reside in the Interlink adult program service area.
Legally able to provide informed consent (18 years of age or older).
Able to speak and read English.
Patients from an intervention designated practice, must agree to referral to Interlink and to receiving an in-home needs assessment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference in unmet supportive care needs between intervention and control group Time Frame: 2 to 3 weeks after baseline; 8 to 10 weeks after baseline	2 to 3 weeks after baseline; 8 to 10 weeks after baseline
Difference in continuity of care between intervention and control group Time Frame: 2 to 3 weeks after baseline; 8 to 10 weeks after baseline	2 to 3 weeks after baseline; 8 to 10 weeks after baseline
Difference in quality of life between intervention and control group Time Frame: 2 to 3 weeks after baseline; 8 to 10 weeks after baseline	2 to 3 weeks after baseline; 8 to 10 weeks after baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
Difference in uncertainty in illness between intervention and control group Time Frame: 2 to 3 weeks after baseline; 8 to 10 weeks after baseline	2 to 3 weeks after baseline; 8 to 10 weeks after baseline
Difference in use of resources between intervention and control group Time Frame: 2 to 3 weeks after baseline; 8 to 10 weeks after baseline	2 to 3 weeks after baseline; 8 to 10 weeks after baseline
Acute stress following surgery Time Frame: 8 to 10 weeks after baseline	8 to 10 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Canadian Institutes of Health Research (CIHR)

Ontario Ministry of Health and Long Term Care

Investigators

Principal Investigator: Jonathan Sussman, MD, CCFP, FRCP (c), MSc, Supportive Cancer Care Research Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Sussman J, Bainbridge D, Whelan TJ, Brazil K, Parpia S, Wiernikowski J, Schiff S, Rodin G, Sergeant M, Howell D. Evaluation of a specialized oncology nursing supportive care intervention in newly diagnosed breast and colorectal cancer patients following surgery: a cluster randomized trial. Support Care Cancer. 2018 May;26(5):1533-1541. doi: 10.1007/s00520-017-3981-4. Epub 2017 Nov 30.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)