Colorectal CancerNCT02247336
Impact of Family History and Decision Support on High-risk Cancer Screening
A study testing Family health history platform (MeTree) in people with Colorectal Cancer, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
Family health history can help identify patients at higher than average risk for disease. There is no standardized system for collecting and updating family health history, using this information to determine a patient's disease risk level, and providing screening recommendations to patients and providers. Read more about this study
- Who is it for?
- Ages 40 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Family health history platform (MeTree)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 505 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2017to 13 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primary care provider inclusion criteria:
- primary care physician,
- physician assistant, or nurse practitioner;
- at least one half-day of primary care clinic per week.
- Patient inclusion criteria:
- assigned to an enrolled PCP;
Show all 12Show fewer
- English as preferred language;
- no plans to relocate or leave the VA system in the next 12 months;
- at least one primary care appointment in the 18 months prior to enrollment;
- upcoming PCP appointment with assigned PCP;
- aged 40-64 years; no previous history of colorectal cancer or adenomatous polyps or inflammatory bowel disease;
- no endoscopy within previous 3 years; some knowledge of family health history
Who cannot join
- n/a (contained within inclusion criteria)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705-2254
About this study
Family health history can help identify patients at higher than average risk for disease. There is no standardized system for collecting and updating family health history, using this information to determine a patient's disease risk level, and providing screening recommendations to patients and providers. Patients will enter their family health history into MeTree, a family history software program. The program will produce screening recommendations tailored to the patient's family health history. The investigators will examine whether this process increases physician referrals for, and patient uptake of, guideline-recommended screening for colorectal cancer.
Read the detailed description
Eligible patients are aged 40-65 years, enrolled in primary care, do not have a personal history of colorectal cancer, and have some knowledge of family health history. In Aim 1, a retrospective chart review will be conducted to determine the baseline rate of documenting family health history of colorectal cancer in the medical record for patients enrolled in the Aim 2 randomized trial. In Aim 2, consented patients will be randomized to provide patient-entered family health history and receive patient and provider decision support at enrollment or 12 months later (wait-list control). The primary outcome is risk-appropriate CRC screening/surveillance referral for patients 12 months post-enrollment. Secondary outcomes include patient uptake of recommendations and referral for genetic consultation 12 months post-enrollment. In Aim 3, qualitative interviews will be conducted with physicians and clinic leaders; data will be analyzed using conventional content analysis. In Aim 4, data will be obtained from the administrative databases and patient medical records to conduct a budget impact analysis.
- Conditions
- Colorectal Cancer
- Being tested
- Family health history platform (MeTree)
- Keywords
- colorectal cancer, early detection of cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family health history platform (MeTree)Behavioural
Participants will enter their family health history information into a family health history platform, patients and providers will receive a decision support document and pedigree
| Study group | Role | What they receive |
|---|---|---|
| Immediate | Experimental | Patients will complete a family health history platform at enrollment Receives: Behavioral: Family health history platform (MeTree) |
| Delayed | Active comparator | Patients will complete a family health history platform 12 months following enrollment Receives: Behavioral: Family health history platform (MeTree) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Provider Referral for Risk-appropriate Colorectal Cancer Screening
Patients who receive guideline-recommended referral consistent with the risk stratum determined by the family health history platform.
Measured: 12 months
Secondary outcomes (2)
Number of Participants Who Received Recommended Colorectal Cancer Screening
Among patients who received a referral, the percentage who received recommended colorectal cancer screening.
Measured: 12 months
Number of Patients Who Received Referral for Genetic Consultation
Of patients who received a recommendation for genetic consultation based on the family history platform, the percentage who received a referral for genetic consultation.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study start1 Aug 2017
- Primary completion13 Jul 2020
- Study completion13 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 505 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Corrine I. Voils, PhD, Principal investigator, William S. Middleton Memorial Veterans Hospital, Madison, WI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247336
- Sponsor's protocol ID
- IIR 12-378
- Status last verified
- Jul 2023
- First submitted
- 18 Sep 2014
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goldstein KM, Fisher DA, Wu RR, Orlando LA, Coffman CJ, Grubber JM, Rakhra-Burris T, Wang V, Scheuner MT, Sperber N, Datta SK, Nelson RE, Strawbridge E, Provenzale D, Hauser ER, Voils CI. An electronic family health history tool to identify and manage patients at increased risk for colorectal cancer: protocol for a randomized controlled trial. Trials. 2019 Oct 7;20(1):576. doi: 10.1186/s13063-019-3659-y.
PubMed 31590688Voils CI, Coffman CJ, Wu RR, Grubber JM, Fisher DA, Strawbridge EM, Sperber N, Wang V, Scheuner MT, Provenzale D, Nelson RE, Hauser E, Orlando LA, Goldstein KM. A Cluster Randomized Trial of a Family Health History Platform to Identify and Manage Patients at Increased Risk for Colorectal Cancer. J Gen Intern Med. 2023 May;38(6):1375-1383. doi: 10.1007/s11606-022-07787-9. Epub 2022 Oct 28.
PubMed 36307642
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Family History and Decision Support on High-risk Cancer Screening
- ClinicalTrials.gov ID
- NCT02247336
- Acronym / sponsor ID
- IIR 12-378
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, early detection of cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 505 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 13 Jul 2020 (actual)
- Study completion
- 13 Jul 2020 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Posted 19 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Family health history can help identify patients at higher than average risk for disease. There is no standardized system for collecting and updating family health history, using this information to determine a patient's disease risk level, and providing screening recommendations to patients and providers. Patients will enter their family health history into MeTree, a family history software program. The program will produce screening recommendations tailored to the patient's family health history. The investigators will examine whether this process increases physician referrals for, and patient uptake of, guideline-recommended screening for colorectal cancer.
Detailed description
Eligible patients are aged 40-65 years, enrolled in primary care, do not have a personal history of colorectal cancer, and have some knowledge of family health history. In Aim 1, a retrospective chart review will be conducted to determine the baseline rate of documenting family health history of colorectal cancer in the medical record for patients enrolled in the Aim 2 randomized trial. In Aim 2, consented patients will be randomized to provide patient-entered family health history and receive patient and provider decision support at enrollment or 12 months later (wait-list control). The primary outcome is risk-appropriate CRC screening/surveillance referral for patients 12 months post-enrollment. Secondary outcomes include patient uptake of recommendations and referral for genetic consultation 12 months post-enrollment. In Aim 3, qualitative interviews will be conducted with physicians and clinic leaders; data will be analyzed using conventional content analysis. In Aim 4, data will be obtained from the administrative databases and patient medical records to conduct a budget impact analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate | Experimental | Behavioral: Family health history platform (MeTree)Patients will complete a family health history platform at enrollment |
| Delayed | Active comparator | Behavioral: Family health history platform (MeTree)Patients will complete a family health history platform 12 months following enrollment |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- primary care physician,
- physician assistant, or nurse practitioner;
- at least one half-day of primary care clinic per week.
- assigned to an enrolled PCP;
- English as preferred language;
Key exclusion criteria (1 listed)
- n/a (contained within inclusion criteria)
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 |
|---|---|---|
| Family health history platform (MeTree)Participants will enter their family health history information into a family health history platform, patients and providers will receive a decision support document and pedigree | Behavioural | Delayed, Immediate |
Primary outcome
Number of Patients With Provider Referral for Risk-appropriate Colorectal Cancer Screening
Time frame: 12 months
Patients who receive guideline-recommended referral consistent with the risk stratum determined by the family health history platform.
2 secondary outcomes
Number of Participants Who Received Recommended Colorectal Cancer Screening
Time frame: 12 months
Number of Patients Who Received Referral for Genetic Consultation
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31590688Goldstein KM, Fisher DA, Wu RR, Orlando LA, Coffman CJ, Grubber JM, Rakhra-Burris T, Wang V, Scheuner MT, Sperber N, Datta SK, Nelson RE, Strawbridge E, Provenzale D, Hauser ER, Voils CI. An electronic family health history tool to identify and manage patients at increased risk for colorectal cancer: protocol for a randomized controlled trial. Trials. 2019 Oct 7;20(1):576. doi: 10.1186/s13063-019-3659-y.
- Derived from this study: PubMed 36307642Voils CI, Coffman CJ, Wu RR, Grubber JM, Fisher DA, Strawbridge EM, Sperber N, Wang V, Scheuner MT, Provenzale D, Nelson RE, Hauser E, Orlando LA, Goldstein KM. A Cluster Randomized Trial of a Family Health History Platform to Identify and Manage Patients at Increased Risk for Colorectal Cancer. J Gen Intern Med. 2023 May;38(6):1375-1383. doi: 10.1007/s11606-022-07787-9. Epub 2022 Oct 28.
- Individual participant dataSharing planned: No
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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.
Corrine I. Voils, PhD principal investigator
William S. Middleton Memorial Veterans Hospital, Madison, WI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family health history platform (MeTree) in people with Colorectal Cancer, run by VA Office of Research and Development at 2 sites in United States.
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 12 inclusion and 1 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 27 Jul 2023. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With Provider Referral for Risk-appropriate Colorectal Cancer Screening (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02247336, which also lists 2 linked publications.
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 27 Jul 2023.