Lynch SyndromeNCT04145388
Family History Study on Cancer Risk
A study testing online cancer risk assessment in people with Lynch Syndrome and Colorectal Cancer, run by Kaiser Permanente at 1 site in United States.
Trial summary
This study aims to identify the optimal method to recognize, risk stratify, and provide follow-up care for individuals at risk of hereditary cancer. The study team will conduct a Hybrid Type II comparative effectiveness-implementation trial, with a mixed methods component and process/formative evaluations for… Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Lynch Syndrome, Colorectal Cancer, Breast Cancer
- What is being tested?
- online cancer risk assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18,623 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 31 Aug 2025
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with ≥2 years of prior membership, ≥1 clinical visit in prior two years, and a listed email are eligible
- Patients must also have received healthcare services during the past 2 years at Kaiser Permanente Northern California (KPNC) sampling sites
Who cannot join
- Patients outside the targeted geographic area
- Patients who cannot speak or read English (given some survey instruments are validated only in English)
- Kaiser Permanente Northern California members in the no-contact database for research studies
Trial locations and contacts
1 site in 1 country.
United States1 site
Division of Research, Kaiser Permanente Northern California
Oakland, California, 94612
About this study
Official title: Systems-Level Capture of Family History Data to Assess Risk of Cancer
This study aims to identify the optimal method to recognize, risk stratify, and provide follow-up care for individuals at risk of hereditary cancer. The study team will conduct a Hybrid Type II comparative effectiveness-implementation trial, with a mixed methods component and process/formative evaluations for stakeholder engagement. The study team will evaluate three methods for identifying and risk-stratifying individuals at risk of hereditary cancer and providing post-risk stratification longitudinal care.
Read the detailed description
The study team proposes a randomized, Hybrid Type II comparative effectiveness-implementation trial, with a mixed methods component and process/formative evaluations for stakeholder engagement. The study team will evaluate three methods for identifying and risk-stratifying individuals at risk of hereditary cancer and providing post-risk stratification longitudinal care.
Hypothesis: The study hypothesis is that Comparator 3 will identify more people at high risk of hereditary cancers and result in more screening behaviors, greater resource use, increased distress, higher perceived risk of cancer and higher satisfaction.
Long term objective: At study end, the study will show: 1) each comparator's strengths and weaknesses, 2) patient preferences, clinical outcomes, and compliance with each step from history collection to screening test completion, 3) the resources needed for each strategy, and 4) the contextual factors that impact their sustainability, dissemination and implementation. Study findings have high potential for generalizability because: 1) The multidisciplinary stakeholder team will help to minimize barriers to dissemination and implementation of the investigator's findings in other research settings; 2) Study results are independent of study setting; 3) The tested methods of family history assessment can occur remotely via paper or electronic interfaces; 4) The care coordination method has successful precedent in other disciplines and can be delivered remotely; 5) A process and formative evaluation with a diverse stakeholder team will inform sustainability, dissemination, and implementation, and result in an implementation guide; 6) The results will be relevant for both family history-based and direct-genetic testing strategies for population screening for hereditary cancer; 7) The results will inform population screening for any disease with hereditary risk.
- Conditions
- Lynch Syndrome, Colorectal Cancer, Breast Cancer, Ovarian Cancer, Family Characteristics, Genetic Predisposition
- Being tested
- online cancer risk assessment, Usual care
- Keywords
- cancer, family characteristics, genetic predisposition, primary care
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis, Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Genetic Predisposition to Disease, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online cancer risk assessmentOther
Electronic surveys to collect family cancer history information.
Usual careOther
Family cancer history captured by provider during a clinical encounter
| Study group | Role | What they receive |
|---|---|---|
| Comparator 1 | Other | Participants will have their cancer risk assessed via usual care. Usual Care is defined as provider capture of family history during a clinical encounter and its entry into the electronic health record (EHR). Participants will take the a patient reported outcomes (PRO) survey once to assess participants experience, perspectives and thoughts on cancer, cancer risk, and cancer risk assessments. Receives: Other: Usual care |
| Comparator 2 | Experimental | Participants will have their cancer risk assessed using a short, standardized web-based questionnaire that will populate validated cancer risk models (such as Breast Cancer Risk Assessment Tool/Gail model 2, PREMM and/or MMRpro) which will take 5-10 minutes to complete. Following the cancer risk assessment, participants will be asked to take a PRO survey. PRO surveys will also be administered at the time of the cancer risk assessment and then 6 and 12 months following. Receives: Other: online cancer risk assessment |
| Comparator 3 | Experimental | Participants will have their cancer risk assessed using a more detailed, full version of the family history survey than the one comparator 2 participants take. This version is a full pedigree assessment, which entails family health history for all 1st, 2nd, and 3rd-degree relatives. Time needed for completion is 15-25 minutes, depending on family size and cancer risk. Participants will also be asked to take the PRO survey following the full cancer risk assessment and also at 6 and 12 months. Receives: Other: online cancer risk assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients identified at high risk of cancer
Number of patients identified at high risk of cancer (cancer syndromes)
Measured: 0 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start1 Jul 2020
- Primary completion15 Mar 2023
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lynch SyndromeStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18,623 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Douglas Corley, MD, PhD, Principal investigator, Division of Research, Kaiser Permanente Northern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145388
- Sponsor's protocol ID
- 1407426
- Status last verified
- Feb 2024
- First submitted
- 30 Sep 2019
- Last updated
- 14 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems-Level Capture of Family History Data to Assess Risk of Cancer
- ClinicalTrials.gov ID
- NCT04145388
- Acronym / sponsor ID
- 1407426
- Conditions
- Lynch Syndrome, Colorectal Cancer, Breast Cancer, Ovarian Cancer, Family Characteristics, Genetic Predisposition
- Keywords
- cancer, family characteristics, genetic predisposition, primary care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18,623 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 30 Oct 2019 (actual)
- 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.
This study aims to identify the optimal method to recognize, risk stratify, and provide follow-up care for individuals at risk of hereditary cancer. The study team will conduct a Hybrid Type II comparative effectiveness-implementation trial, with a mixed methods component and process/formative evaluations for stakeholder engagement. The study team will evaluate three methods for identifying and risk-stratifying individuals at risk of hereditary cancer and providing post-risk stratification longitudinal care.
Detailed description
The study team proposes a randomized, Hybrid Type II comparative effectiveness-implementation trial, with a mixed methods component and process/formative evaluations for stakeholder engagement. The study team will evaluate three methods for identifying and risk-stratifying individuals at risk of hereditary cancer and providing post-risk stratification longitudinal care.
Hypothesis: The study hypothesis is that Comparator 3 will identify more people at high risk of hereditary cancers and result in more screening behaviors, greater resource use, increased distress, higher perceived risk of cancer and higher satisfaction.
Long term objective: At study end, the study will show: 1) each comparator's strengths and weaknesses, 2) patient preferences, clinical outcomes, and compliance with each step from history collection to screening test completion, 3) the resources needed for each strategy, and 4) the contextual factors that impact their sustainability, dissemination and implementation. Study findings have high potential for generalizability because: 1) The multidisciplinary stakeholder team will help to minimize barriers to dissemination and implementation of the investigator's findings in other research settings; 2) Study results are independent of study setting; 3) The tested methods of family history assessment can occur remotely via paper or electronic interfaces; 4) The care coordination method has successful precedent in other disciplines and can be delivered remotely; 5) A process and formative evaluation with a diverse stakeholder team will inform sustainability, dissemination, and implementation, and result in an implementation guide; 6) The results will be relevant for both family history-based and direct-genetic testing strategies for population screening for hereditary cancer; 7) The results will inform population screening for any disease with hereditary risk.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Comparator 1 | Other | Other: Usual careParticipants will have their cancer risk assessed via usual care. Usual Care is defined as provider capture of family history during a clinical encounter and its entry into the electronic health record (EHR). Participants will take the a patient reported outcomes (PRO) survey once to assess participants experience, perspectives and thoughts on cancer, cancer risk, and cancer risk assessments. |
| Comparator 2 | Experimental | Other: online cancer risk assessmentParticipants will have their cancer risk assessed using a short, standardized web-based questionnaire that will populate validated cancer risk models (such as Breast Cancer Risk Assessment Tool/Gail model 2, PREMM and/or MMRpro) which will take 5-10 minutes to complete. Following the cancer risk assessment, participants will be asked to take a PRO survey. PRO surveys will also be administered at the time of the cancer risk assessment and then 6 and 12 months following. |
| Comparator 3 | Experimental | Other: online cancer risk assessmentParticipants will have their cancer risk assessed using a more detailed, full version of the family history survey than the one comparator 2 participants take. This version is a full pedigree assessment, which entails family health history for all 1st, 2nd, and 3rd-degree relatives. Time needed for completion is 15-25 minutes, depending on family size and cancer risk. Participants will also be asked to take the PRO survey following the full cancer risk assessment and also at 6 and 12 months. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients with ≥2 years of prior membership, ≥1 clinical visit in prior two years, and a listed email are eligible
- Patients must also have received healthcare services during the past 2 years at Kaiser Permanente Northern California (KPNC) sampling sites
Key exclusion criteria (3 listed)
- Patients outside the targeted geographic area
- Patients who cannot speak or read English (given some survey instruments are validated only in English)
- Kaiser Permanente Northern California members in the no-contact database for research studies
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 |
|---|---|---|
| online cancer risk assessmentElectronic surveys to collect family cancer history information. | Other | Comparator 2, Comparator 3 |
| Usual careFamily cancer history captured by provider during a clinical encounter | Other | Comparator 1 |
Primary outcome
Number of patients identified at high risk of cancer
Time frame: 0 to 12 months
Number of patients identified at high risk of cancer (cancer syndromes)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
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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.
Douglas Corley, MD, PhD principal investigator
Division of Research, Kaiser Permanente Northern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing online cancer risk assessment in people with Lynch Syndrome and Colorectal Cancer, run by Kaiser Permanente at 1 site 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Feb 2024. 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 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?
Results are not available in the source record.
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 identified at high risk of cancer (time frame: 0 to 12 months). 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 14 Feb 2024.