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A Randomized Trial of Cancer Risk and Health Education in Relatives of Colorectal Cancer Patients

Phase 3
25 Years
65 Years
Not Enrolling
Colon Cancer, Colonic Neoplasms

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Trial Information

A Randomized Trial of Cancer Risk and Health Education in Relatives of Colorectal Cancer Patients

Colorectal cancer (CRC) is the second leading cause of cancer death in North America,
despite being referred to as preventable and curable if detected early. Early detection
through preventive screening has been found to decrease CRC death. However, adherence to CRC
screening is poor, both in average risk and higher risk individuals. Lack of knowledge of
CRC risk and screening recommendations, and psychological factors, such as perceived risk of
CRC have been cited as important factors associated with screening compliance. By increasing
knowledge and appropriate risk comprehension, it is possible to increase lifelong, long-term
screening adherence, rather than one-time compliance. This is especially important because
CRC screening can be unpleasant and if individuals are not clear of their risk and other
important information about CRC, they may be reluctant to continue with a screening program.
Having at least one first-degree relative (FDR) with CRC increases an individual's risk of
developing the disease. Many relatives of CRC probands are ineligible for genetic testing
and, therefore, do not receive information from a healthcare provider about the disease.
Providing relatives of CRC probands with information about their risk of developing CRC,
screening information, and other CRC-related health information, may increase knowledge and
screening compliance as has been shown in relatives of breast cancer patients. Previous
educational interventions with relatives of breast cancer probands have demonstrated
increased knowledge, screening behaviour, risk comprehension, and decreased distress. While
these interventions have been effective with relatives of breast cancer patients, these
interventions have not been conducted to date with relatives of CRC patients. We believe
that relatives of CRC patients could also benefit from this type of educational session.
Educational interventions with relatives of breasts cancer patients have been conducted
in-person, however in clinical genetic counseling, sessions are conducted both in-person and
by telephone. Telephone counseling has become widespread in clinical services despite a lack
of evidence to support its effectiveness compared to in-person counseling. Preliminary
studies have shown that telephone interventions increase participation in screening
programs, but few studies have directly compared telephone and in-person counseling. The
primary aim of this study is to test the efficacy of two modes (in-person vs. telephone) of
providing a risk counseling and health promotion intervention for relatives of CRC probands
on measures of knowledge of CRC risk and health-related factors, comprehension of risk,
understanding of screening recommendations and intent to adopt an appropriate screening
regimen. Participants will be randomized into one of three study arms (in-person, telephone,
control). An assessment pre- and post- intervention will be conducted. In addition,
longer-term follow-ups will be carried out two months and one year following the
intervention to examine the sustainability of the intervention effect.

Inclusion Criteria:

- at least one First Degree Relative (FDR) with Colorectal Cancer

- be between the ages of 25 and 65 years

- live within one hour of Toronto

Exclusion Criteria:

- previous diagnosis of Colorectal Cancer or other malignancy

- family history suggestive of hereditary Colorectal Cancer

- history of major psychiatric disorder (i.e. schizophrenia, active psychosis,
major depression)

- failure to provide consent.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Colorectal cancer risk comprehension and screening knowledge

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Mary Jane Esplen, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto


Canada: Ethics Review Committee

Study ID:




Start Date:

January 2005

Completion Date:

August 2009

Related Keywords:

  • Colon Cancer
  • Colonic Neoplasms
  • Risk counselling
  • Health education
  • Prevention
  • Behavioral
  • Screening
  • Intervention
  • Telephone vs in person
  • Neoplasms
  • Colonic Neoplasms
  • Colorectal Neoplasms