The Effect of a Virtual Navigator on Colorectal Cancer Patient Empowerment

Colorectal Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01549327
• Other study ID #: TEN-C
• Secondary ID: MOP 106710
• Status: Completed
• Phase: N/A
• First received: February 29, 2012
• Last updated: March 22, 2016
• Start date: May 2012
• Est. completion date: May 2015

Study information

• Verified date: March 2016
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Oncology Interactive Navigator

• Routine Care

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec
Canada	McGill University Health Centre	Montreal	Quebec
Canada	Sunnybrook-Odette Cancer Centre	Toronto	Ontario
Canada	CancerCare Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 months	No
Secondary	Cost-effectiveness		8 months	No