The Effect of a Virtual Navigator on Colorectal Cancer Patient Empowerment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01549327|
Recruitment Status : Completed
First Posted : March 9, 2012
Last Update Posted : March 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Other: Oncology Interactive Navigator Other: Routine Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||129 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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)|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
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
- Empowerment [ Time Frame: 8 months ]
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01549327
|Winnipeg, Manitoba, Canada|
|Sunnybrook-Odette Cancer Centre|
|Toronto, Ontario, Canada|
|McGill University Health Centre|
|Montreal, Quebec, Canada, H3G 1A4|
|Jewish General Hospital|
|Montreal, Quebec, Canada, H3T 1E2|
|Principal Investigator:||Carmen G. Loiselle, N., Ph.D.||McGill University|