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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)


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

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)


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Empowerment

Outcome Description:

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.

Outcome Time Frame:

8 months

Safety Issue:

No

Principal Investigator

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

Investigator Role:

Principal Investigator

Investigator Affiliation:

McGill University

Authority:

Canada: Canadian Institutes of Health Research

Study ID:

TEN-C

NCT ID:

NCT01549327

Start Date:

May 2012

Completion Date:

March 2015

Related Keywords:

  • Colorectal Cancer
  • Virtual Patient Navigation
  • Randomized Clinical Trial
  • Empowerment
  • Cost-Effectiveness
  • Cancer Information Preferences
  • Colorectal Neoplasms

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