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SONICS - Effectiveness of Specialist Oncology Nursing

This study is currently recruiting participants.
Study NCT00182234.   Last updated on May 20, 2008.   Information provided by McMaster University

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Descriptive Information Fields
Brief Title  SONICS - Effectiveness of Specialist Oncology Nursing
Official Title  A Study of the Effectiveness of Specialist Oncology Nursing Case Management in Improving Continuity of Supportive Cancer Care in the Community (SONICS)
Brief Summary

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.

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 Phase Phase III
Study Type  Interventional
Study Design  Other, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Difference in unmet supportive care needs between intervention and control group
Difference in continuity of care between intervention and control group
Difference in quality of life between intervention and control group
Secondary Outcome Measure  Difference in uncertainty in illness between intervention and control group
Difference in use of resources between intervention and control group
Acute stress following surgery
Condition  Continuity of Care
Quality of Life
Intervention  Behavioral: Interlink Community Program
MEDLINE PMIDs
Links Supportive Cancer Care Research (SCCR) Unit This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  200
Start Date  December 2005
Completion Date October 2007
Eligibility Criteria 

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.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Daryl Bainbridge, PhD(c)     (905) 387-9711 ext 64515     daryl.bainbridge@hrcc.on.ca    
Location Countries  Canada
Administrative Information Fields
NCT ID  NCT00182234
Organization ID 74867
Secondary IDs †† CIHR - 74867, MOHLTC - 04171
Study Sponsor  Hamilton Health Sciences
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    
Information Provided By McMaster University
Verification Date May 2008
First Received Date  September 13, 2005
Last Updated Date May 20, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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