Cancer Risk Assessment for Hereditary Cancer Risk

Overseen By Laura B Amsden, MSW, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Geographic area, English proficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to identify and care for individuals at risk of hereditary cancer. It compares three methods: usual care (standard-of-care medications for chemotherapy-induced peripheral neuropathy), a short online questionnaire, and a detailed family history survey. Each method assesses a person's cancer risk based on family history and lifestyle. Suitable candidates are adults who have been Kaiser Permanente Northern California members for at least two years and have had healthcare visits during that time. Participants will share their experiences through surveys, helping researchers determine which method is most effective. As an unphased trial, this study allows participants to contribute to innovative research that could enhance cancer risk assessment methods.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these methods for cancer risk assessment are safe?

Research has shown that using online tools to assess cancer risk is generally safe. One study found that these digital platforms gather important information, such as family history and personal health details, without causing harm. This process is non-invasive, meaning it doesn't involve any medical procedures that could cause physical side effects.

Additionally, using these tools might reduce anxiety about cancer risks. Specifically, another study found that people who used genetic risk assessments worried less about cancer. These online assessments simply collect data to help understand cancer risks better. They do not involve any drugs or treatments, so there are no reports of negative effects from using them.

Overall, these online assessments are well-tolerated. Participants provide information about their health and family history, which is then used to help predict cancer risks. Answering questions on a computer poses no risk of physical harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to assess hereditary cancer risk more effectively. Unlike the usual care, which relies on capturing family history during clinical visits, one approach uses a short, web-based questionnaire that quickly feeds into validated cancer risk models, providing potentially faster and more accurate risk assessments. Another method involves a detailed family history survey that gathers extensive information from multiple generations, offering a comprehensive view of potential genetic risks. These approaches could lead to more personalized and timely cancer prevention strategies, helping individuals understand their risk and take proactive steps sooner.

What evidence suggests that this trial's methods for cancer risk assessment could be effective?

This trial will compare different methods of cancer risk assessment. Studies have shown that online tools can effectively gather family health history and calculate cancer risk scores. These tools use proven methods to predict the chances of developing hereditary cancers. Research indicates that digital assessments are faster and more accurate in identifying people at higher risk. In this trial, some participants will have their cancer risk assessed using a short, standardized web-based questionnaire, while others will use a more detailed, full version of the family history survey. Early findings suggest that these online assessments can efficiently determine cancer risk compared to traditional methods, which will be evaluated in this trial as usual care. ^{2 6 7 8 9}

Who Is on the Research Team?

Douglas Corley, MD, PhD

Principal Investigator

Division of Research, Kaiser Permanente Northern California

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been a member for over 2 years, visited the clinic in the last 2 years, and have an email listed.

Patients must also have received healthcare services during the past 2 years at Kaiser Permanente Northern California (KPNC) sampling sites

Exclusion Criteria

Patients who cannot speak or read English (given some survey instruments are validated only in English)

Patients outside the targeted geographic area

Kaiser Permanente Northern California members in the no-contact database for research studies

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Risk Assessment

Participants undergo cancer risk assessment using various methods, including usual care, a short web-based questionnaire, or a detailed family history survey

1-2 weeks

1 visit (virtual or in-person)

Follow-up

Participants are monitored for outcomes and complete PRO surveys at 6 and 12 months post-assessment

12 months

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Online Cancer Risk Assessment
• Usual care

Trial Overview

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.

How Is the Trial Designed?

Group I: Comparator 3 Experimental Treatment 1 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 2 Experimental Treatment 1 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 1 Experimental Treatment 1 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.

Usual care is already approved in United States, European Union for the following indications:

Approved in United States as Standard-of-care medications for CIPN for:

• Chemotherapy-induced peripheral neuropathy (CIPN)

Approved in European Union as Standard-of-care medications for CIPN for:

• Chemotherapy-induced peripheral neuropathy (CIPN)

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

In a study of 488 women receiving docetaxel or paclitaxel, 37.3% of dose-limiting chemotherapy-induced peripheral neuropathy (CIPN) events were attributed to paclitaxel, with a significantly higher incidence (16.1%) compared to docetaxel (2.4%).

Women who experienced dose reductions or treatment discontinuation due to CIPN received significantly less cumulative chemotherapy than planned, indicating that CIPN can impact treatment effectiveness and necessitates further investigation into its implications on patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of chemotherapy-induced peripheral neuropathy on treatment delivery in nonmetastatic breast cancer. Speck, RM., Sammel, MD., Farrar, JT., et al.[2022]

The updated ASCO guidelines recommend altering chemotherapy treatment for patients who develop chemotherapy-induced peripheral neuropathy (CIPN), but they lack clear criteria on when and how to make these alterations based on CIPN severity.

This review provides a patient-centric decision framework for clinicians, emphasizing the need to balance the benefits of reducing CIPN severity against the risks of compromising cancer treatment efficacy when considering changes to neurotoxic chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-centric decision framework for treatment alterations in patients with Chemotherapy-induced Peripheral Neuropathy (CIPN). Hertz, DL., Childs, DS., Park, SB., et al.[2021]

In a study of 126 women treated with taxane-based chemotherapy for breast cancer, 73% reported experiencing chemotherapy-induced peripheral neuropathy (CIPN), which significantly affected their quality of life and physical functioning.

CIPN severity was notably higher in Black or African American women, indicating a need for targeted screening and intervention strategies to address this disparity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prevalence and pattern of chemotherapy-induced peripheral neuropathy among women with breast cancer receiving care in a large community oncology practice. Simon, NB., Danso, MA., Alberico, TA., et al.[2022]

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