Colorectal CancerPhase 3NCT01506687
Increasing Colorectal Cancer Screening Uptake With a Patient Navigator
A Phase 3 study testing Health counselling by nurse navigator and Usual primary care counselling in people with Colorectal Cancer, run by Cancer Care Ontario at 1 site in Canada.
Trial summary
Patients who receive tailored navigation (consisting of a letter and patient navigation services) and get screened will be significantly greater than the control group who receives treatment as usual. Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Health counselling by nurse navigator and Usual primary care counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to Jun 2012
- 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 50 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Average risk men and women aged 50 - 74
- Unscreened - Defined as no prior CRC screening
- Under-screened - Defined as no FOBT screening within the last two years
- No colonoscopy or barium enema screening within the last five years
- Willing to provide consent to participate in the study.
Who cannot join
- FOBT within the last two years
- colonoscopy within five years
- barium enema within five years
- flexible sigmoidoscopy within five years
- Bowel cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increasing Colorectal Cancer Screening Uptake With a Patient Navigator - Phase III Trial
Patients who receive tailored navigation (consisting of a letter and patient navigation services) and get screened will be significantly greater than the control group who receives treatment as usual.
A majority of patients will opt for Fecal Occult Blood Testing (FOBT)as one of their preferred tests, after undergoing the "Patient Navigator" intervention and that proportion will be significantly greater than the group who opt for FOBT in the control group.
Read the detailed description
Primary Outcome Measure:
Number of patients who receive a letter and patient navigation services and get screened compared to the control group.
Secondary Outcome Measures:
Proportion (%) of patients preferring FOBT vs.colonoscopy; Predictors of CRC screening and screening preference.
Subjects: Ambulatory patients (men-women aged 50 years and above) recruited from primary care practices at the Group Health Centre, Sault Ste Marie, Ontario. All patients will be screened for eligibility and those who are eligible and agree to participate in the study will be randomized to either of the two study arms: intervention group or control group.
- Conditions
- Colorectal Cancer
- Being tested
- Health counselling by nurse navigator, Usual primary care counselling
- Keywords
- Colorectal cancer screening, 50 years or older
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health counselling by nurse navigatorBehavioural
Also called Nurse navigator assistance
Information on colorectal cancer and screening, assistance in selection of screening option and obtaining kit or colonoscopy referral
Usual primary care counsellingBehavioural
Also called Usual primary care
Usual care health counselling on colorectal cancer and screening options
| Study group | Role | What they receive |
|---|---|---|
| Navigator intervention | Experimental | Not described Receives: Behavioral: Health counselling by nurse navigator |
| Usual Care Control | Active comparator | Usual care Receives: Behavioral: Usual primary care counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of verified CRC screening event (FOBT;colonoscopy) event in experimental vs. control groups within 48 weeks
Completion of verified CRC screening events in experimental vs. control patients
Measured: 48 weeks after baseline assessment
Secondary outcomes (1)
Screening preferences; predictors of CRC screening and screening preference.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startJan 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Care Ontario
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Paul Ritvo, Ph.D., Cancer Care Ontario
- Investigators
- Paul Ritvo, PHD, Principal investigator, Cancer Care Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506687
- Sponsor's protocol ID
- 10-163
- Status last verified
- Dec 2013
- First submitted
- 27 Jun 2011
- Last updated
- 3 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Colorectal Cancer Screening Uptake With a Patient Navigator - Phase III Trial
- ClinicalTrials.gov ID
- NCT01506687
- Acronym / sponsor ID
- 10-163
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer screening, 50 years or older
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Cancer Care OntarioUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jan 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 10 Jan 2012 (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.
Patients who receive tailored navigation (consisting of a letter and patient navigation services) and get screened will be significantly greater than the control group who receives treatment as usual.
A majority of patients will opt for Fecal Occult Blood Testing (FOBT)as one of their preferred tests, after undergoing the "Patient Navigator" intervention and that proportion will be significantly greater than the group who opt for FOBT in the control group.
Detailed description
Primary Outcome Measure:
Number of patients who receive a letter and patient navigation services and get screened compared to the control group.
Secondary Outcome Measures:
Proportion (%) of patients preferring FOBT vs.colonoscopy; Predictors of CRC screening and screening preference.
Subjects: Ambulatory patients (men-women aged 50 years and above) recruited from primary care practices at the Group Health Centre, Sault Ste Marie, Ontario. All patients will be screened for eligibility and those who are eligible and agree to participate in the study will be randomized to either of the two study arms: intervention group or control group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Navigator intervention | Experimental | Behavioral: Health counselling by nurse navigator |
| Usual Care Control | Active comparator | Behavioral: Usual primary care counsellingUsual care |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Average risk men and women aged 50 - 74
- Unscreened - Defined as no prior CRC screening
- Under-screened - Defined as no FOBT screening within the last two years
- No colonoscopy or barium enema screening within the last five years
- Willing to provide consent to participate in the study.
Key exclusion criteria (5 listed)
- FOBT within the last two years
- colonoscopy within five years
- barium enema within five years
- flexible sigmoidoscopy within five years
- Bowel cancer.
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 |
|---|---|---|
| Health counselling by nurse navigatorAlso: Nurse navigator assistanceInformation on colorectal cancer and screening, assistance in selection of screening option and obtaining kit or colonoscopy referral | Behavioural | Navigator intervention |
| Usual primary care counsellingAlso: Usual primary careUsual care health counselling on colorectal cancer and screening options | Behavioural | Usual Care Control |
Primary outcome
Completion of verified CRC screening event (FOBT;colonoscopy) event in experimental vs. control groups within 48 weeks
Time frame: 48 weeks after baseline assessment
Completion of verified CRC screening events in experimental vs. control patients
1 secondary outcome
Screening preferences; predictors of CRC screening and screening preference.
Time frame: 48 weeks
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 3 Dec 2013.
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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.
Paul Ritvo, PHD principal investigator
Cancer Care Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Health counselling by nurse navigator and Usual primary care counselling in people with Colorectal Cancer, run by Cancer Care Ontario at 1 site 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 5 inclusion and 5 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 3 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Completion of verified CRC screening event (FOBT;colonoscopy) event in experimental vs. control groups within 48 weeks (time frame: 48 weeks after baseline assessment). 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 3 Dec 2013.