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Clinical Trials/NCT01549327
NCT01549327
Completed
Not Applicable

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)

McGill University4 sites in 1 country129 target enrollmentMay 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
McGill University
Enrollment
129
Locations
4
Primary Endpoint
Empowerment
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2012
End Date
May 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carmen G. Loiselle, N., Ph.D.

Associate Professor, Christine and Herschel Victor / Hope & Cope Chair in Psychosocial Oncology

McGill University

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

Outcomes

Primary Outcomes

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. Reference: Osborne RH et al. Patient Educ Couns. 2007;66:192-201.

Secondary Outcomes

  • Cost-effectiveness(8 months)

Study Sites (4)

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