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Cancer Risk Assessment for Hereditary Cancer Risk

N/A

Waitlist Available

Led By Douglas Corley, MD, PhD

Research Sponsored by Kaiser Permanente

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare three methods for identifying and risk-stratifying individuals at risk of hereditary cancer, and providing post-risk stratification longitudinal care.

Who is the study for?

This trial is for adults who've been members of Kaiser Permanente Northern California for at least 2 years, have visited a clinic in the past two years, and have an email on file. It's not open to those outside the targeted area, in the no-contact database, or unable to read English.

What is being tested?

The study compares three methods of identifying and managing individuals at risk of hereditary cancers like colorectal and breast cancer. Participants will either receive usual care or go through an online cancer risk assessment tool.

What are the potential side effects?

Since this trial involves non-medical interventions such as usual care and online assessments rather than drugs or medical procedures, traditional side effects are not applicable.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients identified at high risk of cancer

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Comparator 3Experimental Treatment1 Intervention

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.

Group II: Comparator 2Experimental Treatment1 Intervention

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.

Group III: Comparator 1Experimental Treatment1 Intervention

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.

Do I qualify?Apply below to find out