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Family History Study on Cancer Risk

Primary Purpose

Lynch Syndrome, Colorectal Cancer, Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
online cancer risk assessment
Usual care
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Lynch Syndrome focused on measuring cancer, family characteristics, genetic predisposition, primary care

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Division of Research, Kaiser Permanente Northern CaliforniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Experimental

Arm Label

Comparator 1

Comparator 2

Comparator 3

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Number of patients identified at high risk of cancer
Number of patients identified at high risk of cancer (cancer syndromes)

Secondary Outcome Measures

Full Information

First Posted
September 30, 2019
Last Updated
December 7, 2022
Sponsor
Kaiser Permanente
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04145388
Brief Title
Family History Study on Cancer Risk
Official Title
Systems-Level Capture of Family History Data to Assess Risk of Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lynch Syndrome, Colorectal Cancer, Breast Cancer, Ovarian Cancer, Family Characteristics, Genetic Predisposition
Keywords
cancer, family characteristics, genetic predisposition, primary care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Comparator 1
Arm Type
Other
Arm Description
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.
Arm Title
Comparator 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Comparator 3
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
online cancer risk assessment
Intervention Description
Electronic surveys to collect family cancer history information.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Family cancer history captured by provider during a clinical encounter
Primary Outcome Measure Information:
Title
Number of patients identified at high risk of cancer
Description
Number of patients identified at high risk of cancer (cancer syndromes)
Time Frame
0 to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura B Amsden, MSW, MPH
Phone
510-891-3870
Email
laura.b.amsden@kp.org
First Name & Middle Initial & Last Name or Official Title & Degree
Cecilia Doan, MPH
Phone
510-891-3710
Email
cecilia.doan@kp.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Corley, MD, PhD
Organizational Affiliation
Division of Research, Kaiser Permanente Northern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Research, Kaiser Permanente Northern California
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura B Amsden, MSW, MPH
Phone
510-891-3870
Email
laura.b.amsden@kp.org
First Name & Middle Initial & Last Name & Degree
Cecilia Doan, MPH
Phone
510-891-3710
Email
cecilia.doan@kp.org

12. IPD Sharing Statement

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Family History Study on Cancer Risk

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