The Effect of a Virtual Navigator on Colorectal Cancer Patient Empowerment

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: Oncology Interactive Navigator
* Other: Routine Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Routine Care<br>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<br> <br> |
| Experimental: Routine Care plus OIN<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness |  | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Patient Navigation, Randomized Clinical Trial, Empowerment, Cost-Effectiveness, Cancer Information Preferences