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OpenTrials
Completed

NCT Number: NCT01549327

The Effect of a Virtual Navigator on Colorectal Cancer Patient Empowerment

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CancerCare Manitoba, Winnipeg, Manitoba, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oncology Interactive Navigator

Other

Routine care

Other

Primary outcomes

  1. 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

  1. Cost-effectiveness

    Time frame: 8 months

Sponsors and collaborators

Lead sponsor

McGill University

Other

Registry information

Official study 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)

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 9, 2012
Registry last updated
Mar 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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