The Effect of a Virtual Navigator on Colorectal Cancer Patient Empowerment
Recruitment status was Recruiting
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.
Other: Oncology Interactive Navigator
Other: Routine Care
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|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)|
- Empowerment [ Time Frame: 8 months ] [ Designated as safety issue: No ]
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.
Osborne RH et al. Patient Educ Couns. 2007;66:192-201.
- Cost-effectiveness [ Time Frame: 8 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Routine Care
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.
|Other: Routine Care|
Experimental: Routine Care plus OIN
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.
|Other: Oncology Interactive Navigator|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549327
|Contact: Carmen G. Loiselle, Ph.D||514-340-8222 ext firstname.lastname@example.org|
|Winnipeg, Manitoba, Canada|
|Sunnybrook-Odette Cancer Centre||Recruiting|
|Toronto, Ontario, Canada|
|Jewish General Hospital||Recruiting|
|Montreal, Quebec, Canada, H3T 1E2|
|Contact: Carmen G. Loiselle, N., Ph.D. 514-340-8222 ext 3940 email@example.com|
|Principal Investigator: Carmen G. Loiselle, N.,Ph.D.|
|McGill University Health Centre||Not yet recruiting|
|Montreal, Quebec, Canada, H3G 1A4|
|Contact: Virginia Lee, PhD 514-934-1934 ext 44371|
|Principal Investigator:||Carmen G. Loiselle, N., Ph.D.||McGill University|