The Effect of a Virtual Navigator on Colorectal Cancer Patient Empowerment
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2013 by McGill University.
Recruitment status was Recruiting
Information provided by (Responsible Party):
Carmen G. Loiselle, N., Ph.D., McGill University
First received: February 29, 2012
Last updated: March 14, 2013
Last verified: March 2013
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.
Other: Oncology Interactive Navigator
Other: Routine Care
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
||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)
Primary Outcome Measures:
- 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.
Osborne RH et al. Patient Educ Couns. 2007;66:192-201.
Secondary Outcome Measures:
- Cost-effectiveness [ Time Frame: 8 months ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2014 (Final data collection date for primary outcome measure)
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.
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.
Other: Oncology Interactive Navigator
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01549327
|Winnipeg, Manitoba, Canada |
|Sunnybrook-Odette Cancer Centre
|Toronto, Ontario, Canada |
|McGill University Health Centre
|Montreal, Quebec, Canada, H3G 1A4 |
|Contact: Virginia Lee, PhD 514-934-1934 ext 44371 |
|Jewish General Hospital
|Montreal, Quebec, Canada, H3T 1E2 |
|Contact: Carmen G. Loiselle, N., Ph.D. 514-340-8222 ext 3940 firstname.lastname@example.org |
|Principal Investigator: Carmen G. Loiselle, N.,Ph.D. |
||Carmen G. Loiselle, N., Ph.D.
No publications provided
||Carmen G. Loiselle, N., Ph.D., Associate Professor, Christine and Herschel Victor / Hope & Cope Chair in Psychosocial Oncology, McGill University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 29, 2012
||March 14, 2013
||Canada: Canadian Institutes of Health Research
Keywords provided by McGill University:
Virtual Patient Navigation
Randomized Clinical Trial
Cancer Information Preferences
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on February 10, 2016
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site