Colon CancerPhase 3NCT00188305
A Randomized Trial of Cancer Risk and Health Education in Relatives of Colorectal Cancer Patients
A Phase 3 study testing General health counselling and risk information in people with Colon Cancer and Colonic Neoplasms, run by University Health Network, Toronto at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer, Colonic Neoplasms
- What is being tested?
- General health counselling and risk information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2005to Aug 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Health Sciences Centre, Memorial University
St. John's, Newfoundland and Labrador, A1B 3V6
University Health Network
Toronto, Ontario, M5G 2C4
About this study
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.
Read the 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.
- Conditions
- Colon Cancer, Colonic Neoplasms
- Being tested
- General health counselling and risk information
- Keywords
- Risk counselling, Health education, Prevention, Behavioral, Screening, Intervention, Telephone vs in person
- Medical subject headings
- Colonic Neoplasms, Health Education, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General health counselling and risk informationBehavioural
General health counselling and risk information
| Study group | Role | What they receive |
|---|---|---|
| 1 In person | Experimental | In person general health, colorectal cancer risk information and screening recommendations. Receives: Behavioral: General health counselling and risk information |
| 2 Telephone | Active comparator | Telephone general health counselling, colorectal cancer risk information and screening recommendations. Receives: Behavioral: General health counselling and risk information |
| 3 Control | Placebo comparator | Standard care for 2 months followed by summary letter with general health information, colorectal cancer risk information and screening recommendations. Receives: Behavioral: General health counselling and risk information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal cancer risk comprehension and screening knowledge
Measured: 1 year
Intent to screen the colon
Measured: 1 year
Colon screening behaviour
Measured: 2 years
Secondary outcomes (3)
Personality
Measured: Baseline
Psychosocial functioning
Measured: 1 year
Satisfaction
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionJun 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Mary Jane Esplen, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00188305
- Sponsor's protocol ID
- UHN04-0729-CE
- Status last verified
- Aug 2015
- First submitted
- 9 Sep 2005
- Last updated
- 17 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Cancer Risk and Health Education in Relatives of Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT00188305
- Acronym / sponsor ID
- UHN04-0729-CE
- Conditions
- Colon Cancer, Colonic Neoplasms
- Keywords
- Risk counselling, Health education, Prevention, Behavioral, Screening, Intervention, Telephone vs in person
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jan 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 In person | Experimental | Behavioral: General health counselling and risk informationIn person general health, colorectal cancer risk information and screening recommendations. |
| 2 Telephone | Active comparator | Behavioral: General health counselling and risk informationTelephone general health counselling, colorectal cancer risk information and screening recommendations. |
| 3 Control | Placebo comparator | Behavioral: General health counselling and risk informationStandard care for 2 months followed by summary letter with general health information, colorectal cancer risk information and screening recommendations. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General health counselling and risk informationGeneral health counselling and risk information | Behavioural | 1 In person, 2 Telephone, 3 Control |
Primary outcome
Colorectal cancer risk comprehension and screening knowledge
Time frame: 1 year
Intent to screen the colon
Time frame: 1 year
Colon screening behaviour
Time frame: 2 years
3 secondary outcomes
Personality
Time frame: Baseline
Psychosocial functioning
Time frame: 1 year
Satisfaction
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Jane Esplen, PhD principal investigator
University Health Network, Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing General health counselling and risk information in people with Colon Cancer and Colonic Neoplasms, run by University Health Network, Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colorectal cancer risk comprehension and screening knowledge (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2015.