The Effect of a Virtual Navigator on Colorectal Cancer Patient Empowerment - Full Text View

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
Colorectal Cancer	Other: Oncology Interactive Navigator Other: Routine Care


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:

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

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 ]


Enrollment:	129
Study Start Date:	May 2012
Study Completion Date:	May 2015
Primary Completion Date:	May 2015 (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 (Adult, Senior)
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

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


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 22, 2016
Health Authority:	Canada: Canadian Institutes of Health Research
Individual Participant Data
Plan to Share IPD:	No

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 September 27, 2016