A Randomized Trial of Cancer Risk and Health Education in Relatives of Colorectal Cancer Patients
August 14, 2015 updated by: University Health Network, Toronto
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
252
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
- Health Sciences Centre, Memorial University
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Ontario
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Toronto, Ontario, Canada, M5G 2C4
- University Health Network
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1 In person
In person general health, colorectal cancer risk information and screening recommendations.
|
General health counselling and risk information
|
|
Active Comparator: 2 Telephone
Telephone general health counselling, colorectal cancer risk information and screening recommendations.
|
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.
|
General health counselling and risk information
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Colorectal cancer risk comprehension and screening knowledge
Time Frame: 1 year
|
1 year
|
|
Intent to screen the colon
Time Frame: 1 year
|
1 year
|
|
Colon screening behaviour
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Personality
Time Frame: Baseline
|
Baseline
|
|
Psychosocial functioning
Time Frame: 1 year
|
1 year
|
|
Satisfaction
Time Frame: 2 months
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Mary Jane Esplen, PhD, University Health Network, Toronto
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
August 1, 2009
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Estimate)
August 17, 2015
Last Update Submitted That Met QC Criteria
August 14, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHN04-0729-CE
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