Family History Study on Cancer Risk

NCT04145388 | Active Not Recruiting

• 1 other identifier: 1407426
• Study Type: interventional
• Target: 18,623
• Locations: 1 country
• Sites: 1

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.

Conditions

Lynch Syndrome; Colorectal Cancer; Breast Cancer; Ovarian Cancer; Family Characteristics; Genetic Predisposition

Keywords

cancer; family characteristics; genetic predisposition; primary care

Outcome Measures

Primary Outcomes (1)

• Number of patients identified at high risk of cancer

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

  0 to 12 months

Study Arms (3)

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.

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.

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.

Other: online cancer risk assessment

Interventions

online cancer risk assessment OTHER

Electronic surveys to collect family cancer history information.

Comparator 2; Comparator 3

Usual care OTHER

Family cancer history captured by provider during a clinical encounter

Comparator 1

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Division of Research, Kaiser Permanente Northern California

Oakland, California, 94612, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis; Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Genetic Predisposition to Disease; Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Rectal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Douglas Corley, MD, PhD

  Division of Research, Kaiser Permanente Northern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 30, 2019
• Study Start: July 1, 2020
• Primary Completion: March 15, 2023
• Study Completion: August 31, 2025
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

US (1)