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
  Purpose

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 Intervention Phase
Colorectal Cancer
Other: Oncology Interactive Navigator
Other: Routine Care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by McGill University:

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.

    Reference:

    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: 411
Study Start Date: May 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01549327

Contacts
Contact: Carmen G. Loiselle, Ph.D 514-340-8222 ext 3940 carmen.g.loiselle@mcgill.ca

Locations
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada
Canada, Ontario
Sunnybrook-Odette Cancer Centre Recruiting
Toronto, Ontario, Canada
Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Carmen G. Loiselle, N., Ph.D.    514-340-8222 ext 3940    carmen.g.loiselle@mcgill.ca   
Principal Investigator: Carmen G. Loiselle, N.,Ph.D.         
McGill University Health Centre Not yet recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: Virginia Lee, PhD    514-934-1934 ext 44371      
Sponsors and Collaborators
McGill University
Investigators
Principal Investigator: Carmen G. Loiselle, N., Ph.D. McGill University
  More Information

No publications provided

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
Study First Received: February 29, 2012
Last Updated: March 14, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by 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

ClinicalTrials.gov processed this record on July 26, 2014