The Effect of a Virtual Navigator on Colorectal Cancer Patient Empowerment
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Oncology Interactive Navigator
Routine Care
Sponsored by
About this trial
This is an interventional supportive care trial for Colorectal Cancer focused on measuring Virtual Patient Navigation, Randomized Clinical Trial, Empowerment, Cost-Effectiveness, Cancer Information Preferences
Eligibility Criteria
Inclusion Criteria:
- histologically confirmed, first diagnosis of colorectal cancer (all stages)
- within 20 weeks of when the individual was told s/he has colorectal cancer
- fluent in English or French; able and willing to complete questionnaires
- unrestricted home Internet access
- has used the Internet at least once in the past
- informed consent
Exclusion Criteria:
- previous history of CRC at any time, or any other cancer diagnosed within the last 5 years (exception: superficial skin cancer)
- medical or severe health problem
- terminal phase of colorectal cancer or too sick to participate
Sites / Locations
- CancerCare Manitoba
- Sunnybrook-Odette Cancer Centre
- McGill University Health Centre
- Jewish General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Routine Care
Routine Care plus OIN
Arm Description
Participants who are randomized to the active comparator arm will receive routine care, which is the care routinely provided to the participant's patient population at the study centre.
OIN (Oncology Interactive Navigator) is the intervention. Participants who are randomized to routine care plus OIN will receive routine care and have unlimited access to the website for the study duration.
Outcomes
Primary Outcome Measures
Empowerment
The main outcome for this trial is empowerment which is multidimensional. Key dimensions of empowerment are measured using five constructs from the health education impact Questionnaire system (reference). Repeated measures using analysis of variance will be used to compare patterns of change in empowerment constructs across time between trial groups.
Reference:
Osborne RH et al. Patient Educ Couns. 2007;66:192-201.
Secondary Outcome Measures
Cost-effectiveness
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01549327
Brief Title
The Effect of a Virtual Navigator on Colorectal Cancer Patient Empowerment
Official Title
A Web-Based Person-Centred Navigation Tool for Newly Diagnosed Colorectal Cancer Patients: A Randomized Clinical Trial (RCT) to Assess Effects on Empowerment and Cost-Effectiveness (The TEN-C Study: Together to Enhance Navigation in Cancer)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
For individuals diagnosed with colorectal cancer, exposure to up-to-date cancer information and support as well as guidance to access the most appropriate health care services is crucial for cancer self-management and support. Timely access to high quality cancer information is suggested to contribute to patient empowerment - defined as the perception of being better able to manage illness demands. With the advent of the information age, individuals are increasingly turning to online health information resources. The use of rigorous web-based tools is found to be an engaging and convenient way to access health information, while being tailored to people's needs and preferences. The present study seeks to examine the effects of a recently developed high quality and person-centred web-based tool, the Oncology Interactive Navigator (OIN) on patients' empowerment as well as document its cost-effectiveness. Participants newly diagnosed with colorectal cancer will be randomly assigned to experimental or control groups with the former having unrestricted access to the OIN for 8 months. Participants in the control group will receive care as usual. Information on background, medical characteristics, and empowerment will be collected as well as cost-effectiveness indicators. If producing the desired effects, the OIN could be proposed for national implementation across Canadian cancer centers. Work is currently underway to add over 23 types of cancer diagnosis to the OIN.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Virtual Patient Navigation, Randomized Clinical Trial, Empowerment, Cost-Effectiveness, Cancer Information Preferences
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Routine Care
Arm Type
Active Comparator
Arm Description
Participants who are randomized to the active comparator arm will receive routine care, which is the care routinely provided to the participant's patient population at the study centre.
Arm Title
Routine Care plus OIN
Arm Type
Experimental
Arm Description
OIN (Oncology Interactive Navigator) is the intervention. Participants who are randomized to routine care plus OIN will receive routine care and have unlimited access to the website for the study duration.
Intervention Type
Other
Intervention Name(s)
Oncology Interactive Navigator
Intervention Type
Other
Intervention Name(s)
Routine Care
Primary Outcome Measure Information:
Title
Empowerment
Description
The main outcome for this trial is empowerment which is multidimensional. Key dimensions of empowerment are measured using five constructs from the health education impact Questionnaire system (reference). Repeated measures using analysis of variance will be used to compare patterns of change in empowerment constructs across time between trial groups.
Reference:
Osborne RH et al. Patient Educ Couns. 2007;66:192-201.
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Cost-effectiveness
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
histologically confirmed, first diagnosis of colorectal cancer (all stages)
within 20 weeks of when the individual was told s/he has colorectal cancer
fluent in English or French; able and willing to complete questionnaires
unrestricted home Internet access
has used the Internet at least once in the past
informed consent
Exclusion Criteria:
previous history of CRC at any time, or any other cancer diagnosed within the last 5 years (exception: superficial skin cancer)
medical or severe health problem
terminal phase of colorectal cancer or too sick to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen G. Loiselle, N., Ph.D.
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Sunnybrook-Odette Cancer Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of a Virtual Navigator on Colorectal Cancer Patient Empowerment
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