A Randomized Trial of Cancer Risk and Health Education in Relatives of Colorectal Cancer Patients
Condition: Colon Cancer; Colonic Neoplasms
MeSH terms: Colonic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Having at least one first-degree relative (FDR) with colon cancer increases an individual's
      risk of developing the disease. Many relatives of cancer patients are ineligible for genetic
      testing and, therefore, do not receive information from a healthcare provider about the
      disease. Providing relatives of cancer patients with information about their risk of
      developing colon cancer, screening information, and other colon-related health information,
      may increase knowledge and screening compliance as has been shown in relatives of breast
      cancer patients. 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 cancer patients on measures of knowledge of colon cancer 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.
    

Detailed description: 
      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.
    

Intervention name(s): General health counselling and risk information
Intervention type(s): Behavioral
Intervention description(s): General health counselling and risk information
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Risk counselling; Health education; Prevention; Behavioral; Screening; Intervention; Telephone vs in person