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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
Sponsor:
Information provided by (Responsible Party):
Carmen G. Loiselle, N., Ph.D., McGill University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: Oncology Interactive Navigator Other: Routine Care Not Applicable

Study Design
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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

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U.S. FDA Resources

Arms and Interventions
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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.
 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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Cost-effectiveness [ Time Frame: 8 months ]

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

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
McGill University
Investigators
Principal Investigator: Carmen G. Loiselle, N., Ph.D. McGill University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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