The Effect of a Virtual Navigator on Colorectal Cancer Patient Empowerment
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)
2 other identifiers
interventional
129
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable colorectal-cancer
Started May 2012
Typical duration for not_applicable colorectal-cancer
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 29, 2012
CompletedFirst Posted
Study publicly available on registry
March 9, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMarch 23, 2016
March 1, 2016
3 years
February 29, 2012
March 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
8 months
Secondary Outcomes (1)
Cost-effectiveness
8 months
Study Arms (2)
Routine Care
ACTIVE COMPARATORParticipants 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.
Routine Care plus OIN
EXPERIMENTALOIN (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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Sunnybrook-Odette Cancer Centre
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, H3G 1A4, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carmen G. Loiselle, N., Ph.D.
McGill University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Christine and Herschel Victor / Hope & Cope Chair in Psychosocial Oncology
Study Record Dates
First Submitted
February 29, 2012
First Posted
March 9, 2012
Study Start
May 1, 2012
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
March 23, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share