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CompletedNCT01549327Updated Mar 23, 2016

The Effect of a Virtual Navigator on Colorectal Cancer Patient Empowerment

An interventional study of Oncology Interactive Navigator and Routine Care in Colorectal Cancer, sponsored by McGill University. Completed at 4 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-23.

Sponsored by McGill University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
129
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Cancer

Keywords

  • Virtual Patient Navigation
  • Randomized Clinical Trial
  • Empowerment
  • Cost-Effectiveness
  • Cancer Information Preferences
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 129 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

McGill University is the lead sponsor of 244 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
129 participants (actual)

Study arms

  • 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

Interventions

  • OtherOncology Interactive Navigator
  • OtherRoutine Care
06

What researchers measure

Primary outcomes

  1. Empowerment

    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.

    Time frame: 8 months

Secondary outcomes

  1. Cost-effectiveness

    Time frame: 8 months

07

Study locations

4 sites
  • CancerCare Manitoba
    Winnipeg, Manitoba, Canada
  • Sunnybrook-Odette Cancer Centre
    Toronto, Ontario, Canada
  • McGill University Health Centre
    Montreal, Quebec H3G 1A4, Canada
  • Jewish General Hospital
    Montreal, Quebec H3T 1E2, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01549327
Lead sponsor
McGill University
Responsible party
Carmen G. Loiselle, N., Ph.D. (Associate Professor, Christine and Herschel Victor / Hope & Cope Chair in Psychosocial Oncology, McGill University) — Principal investigator
First posted
Mar 9, 2012
Start date
May 2012
Primary completion
May 2015
Completion
May 2015
Last update
Mar 23, 2016

Study contacts

Carmen G. Loiselle, N., Ph.D.
principal investigator · McGill University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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