The Effect of a Virtual Navigator on Colorectal Cancer Patient Empowerment

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by McGill University
Sponsor:
Information provided by (Responsible Party):
Carmen G. Loiselle, N., Ph.D., McGill University
ClinicalTrials.gov Identifier:
NCT01549327
First received: February 29, 2012
Last updated: March 14, 2013
Last verified: March 2013

February 29, 2012
March 14, 2013
May 2012
September 2014   (final data collection date for primary outcome measure)
Empowerment [ Time Frame: 8 months ] [ Designated as safety issue: No ]

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.

Same as current
Complete list of historical versions of study NCT01549327 on ClinicalTrials.gov Archive Site
Cost-effectiveness [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Colorectal Cancer
  • Other: Oncology Interactive Navigator
  • Other: Routine Care
  • Active Comparator: Routine Care
    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.
    Intervention: Other: Routine Care
  • Experimental: Routine Care plus OIN
    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.
    Intervention: Other: Oncology Interactive Navigator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
411
March 2015
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Carmen G. Loiselle, Ph.D 514-340-8222 ext 3940 carmen.g.loiselle@mcgill.ca
Canada
 
NCT01549327
TEN-C, MOP 106710
No
Carmen G. Loiselle, N., Ph.D., McGill University
McGill University
Not Provided
Principal Investigator: Carmen G. Loiselle, N., Ph.D. McGill University
McGill University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP