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SONICS - Effectiveness of Specialist Oncology Nursing

This study is currently recruiting participants.
Verified by Hamilton Health Sciences, May 2008

Sponsors and Collaborators: Hamilton Health Sciences
Canadian Institutes of Health Research (CIHR)
Ontario Ministry of Health and Long Term Care
Information provided by: Hamilton Health Sciences
ClinicalTrials.gov Identifier: NCT00182234
  Purpose

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.


Condition Intervention Phase
Continuity of Care
Quality of Life
Behavioral: Interlink Community Program
Phase III

MedlinePlus related topics:   Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   A Study of the Effectiveness of Specialist Oncology Nursing Case Management in Improving Continuity of Supportive Cancer Care in the Community (SONICS)

Further study details as provided by Hamilton Health Sciences:

Primary Outcome Measures:
  • 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 Measures:
  • Difference in uncertainty in illness between intervention and control group
  • Difference in use of resources between intervention and control group
  • Acute stress following surgery

Estimated Enrollment:   200
Study Start Date:   December 2005
Estimated Study Completion Date:   October 2007
Estimated Primary Completion Date:   December 2008 (Final data collection date for primary outcome measure)

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182234

Contacts
Contact: Daryl Bainbridge, PhD(c)     (905) 387-9711 ext 64515     daryl.bainbridge@hrcc.on.ca    

Locations
Canada, Ontario
Princess Margaret Hospital     Recruiting
      Toronto, Ontario, Canada, M5G 2M9
      Contact: Gary Rodin, MD     (416) 924-2200 ext 5405     Gary.Rodin@uhn.on.ca    
      Principal Investigator: Doris Howell, RN, PhD            

Sponsors and Collaborators
Hamilton Health Sciences
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    
  More Information

Supportive Cancer Care Research (SCCR) Unit  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Hamilton Health Sciences ( Dr. Jonathan Sussman )
Study ID Numbers:   74867, CIHR - 74867, MOHLTC - 04171
First Received:   September 13, 2005
Last Updated:   May 20, 2008
ClinicalTrials.gov Identifier:   NCT00182234
Health Authority:   Canada: Health Canada

Keywords provided by Hamilton Health Sciences:
unmet supportive care needs  

Study placed in the following topic categories:
Quality of Life

ClinicalTrials.gov processed this record on September 05, 2008




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