The Effect of a Virtual Navigator on Colorectal Cancer Patient Empowerment

NCT ID: NCT01549327

Last Updated: 2016-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2015-05-31

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Routine Care

Intervention Type: OTHER

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.

Group Type: EXPERIMENTAL

Oncology Interactive Navigator

Intervention Type: OTHER

Interventions

Oncology Interactive Navigator

Intervention Type: OTHER

Routine Care

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University

OTHER

Sponsor Role: lead

Responsible Party

Carmen G. Loiselle, N., Ph.D.

Associate Professor, Christine and Herschel Victor / Hope & Cope Chair in Psychosocial Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carmen G. Loiselle, N., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

McGill University

Locations

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Sunnybrook-Odette Cancer Centre

Toronto, Ontario, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

MOP 106710

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

TEN-C

Identifier Type: -

Identifier Source: org_study_id