The Effect of a Virtual Navigator on Colorectal Cancer Patient Empowerment
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ClinicalTrials.gov Identifier: NCT01549327 |
Recruitment Status
:
Completed
First Posted
: March 9, 2012
Last Update Posted
: March 23, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer | Other: Oncology Interactive Navigator Other: Routine Care | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 129 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official 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) |
Study Start Date : | May 2012 |
Actual Primary Completion Date : | May 2015 |
Actual Study Completion Date : | May 2015 |

Arm | Intervention/treatment |
---|---|
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.
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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 |
- 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.
- Cost-effectiveness [ Time Frame: 8 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01549327
Canada, Manitoba | |
CancerCare Manitoba | |
Winnipeg, Manitoba, Canada | |
Canada, Ontario | |
Sunnybrook-Odette Cancer Centre | |
Toronto, Ontario, Canada | |
Canada, Quebec | |
McGill University Health Centre | |
Montreal, Quebec, Canada, H3G 1A4 | |
Jewish General Hospital | |
Montreal, Quebec, Canada, H3T 1E2 |
Principal Investigator: | Carmen G. Loiselle, N., Ph.D. | McGill University |
Responsible Party: | Carmen G. Loiselle, N., Ph.D., Associate Professor, Christine and Herschel Victor / Hope & Cope Chair in Psychosocial Oncology, McGill University |
ClinicalTrials.gov Identifier: | NCT01549327 History of Changes |
Other Study ID Numbers: |
TEN-C MOP 106710 ( Other Grant/Funding Number: CIHR ) |
First Posted: | March 9, 2012 Key Record Dates |
Last Update Posted: | March 23, 2016 |
Last Verified: | March 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Carmen G. Loiselle, N., Ph.D., McGill University:
Virtual Patient Navigation Randomized Clinical Trial Empowerment Cost-Effectiveness Cancer Information Preferences |
Additional relevant MeSH terms:
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |