Clinical trial NCT01549327: 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
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Virtual Patient Navigation
Randomized Clinical Trial
Empowerment
Cost-Effectiveness
Cancer Information Preferences
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2012-03-09
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Empowerment
timeFrame: 8 months
Secondary outcomes:
measure: Cost-effectiveness
timeFrame: 8 months
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: Toronto
country: Canada
facility: Sunnybrook-Odette Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: McGill University
name: Carmen G. Loiselle, N., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: