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

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188305
First received: September 9, 2005
Last updated: August 7, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Colon Cancer
Colonic Neoplasms
Behavioral: General health counselling and risk information
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Randomized Trial of Cancer Risk and Health Education in Relatives of Colorectal Cancer Patients

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Colorectal cancer risk comprehension and screening knowledge [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Intent to screen the colon [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Colon screening behaviour [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Personality [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Psychosocial functioning [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Satisfaction [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 252
Study Start Date: January 2005
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 In person
In person general health, colorectal cancer risk information and screening recommendations.
Behavioral: General health counselling and risk information
General health counselling and risk information
Active Comparator: 2 Telephone
Telephone general health counselling, colorectal cancer risk information and screening recommendations.
Behavioral: General health counselling and risk information
General health counselling and risk information
Placebo Comparator: 3 Control
Standard care for 2 months followed by summary letter with general health information, colorectal cancer risk information and screening recommendations.
Behavioral: General health counselling and risk information
General health counselling and risk information

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.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00188305

Locations
Canada, Newfoundland and Labrador
Health Sciences Centre, Memorial University
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Mary Jane Esplen, PhD University Health Network, Toronto
  More Information

No publications provided

Responsible Party: Dr. Mary Jane Esplen, University Health Network
ClinicalTrials.gov Identifier: NCT00188305     History of Changes
Other Study ID Numbers: UHN04-0729-CE
Study First Received: September 9, 2005
Last Updated: August 7, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Risk counselling
Health education
Prevention
Behavioral
Screening
Intervention
Telephone vs in person

Additional relevant MeSH terms:
Colonic Neoplasms
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 20, 2014