Cancer Risk Assessment for Hereditary Cancer Risk

Overseen By Laura B Amsden, MSW, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

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

18623 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment for chemotherapy-induced peripheral neuropathy?

The research indicates that while there are no preventive therapies with significant clinical efficacy for chemotherapy-induced peripheral neuropathy (CIPN), promising novel agents like histone deacetylase 6 (HDAC6) inhibitors are in early clinical trials. Additionally, drug repurposing, such as using metformin, may offer alternative therapeutic options. ^{1 2 3 4 5}

Is the treatment for hereditary cancer risk assessment safe for humans?

The safety data for treatments related to chemotherapy-induced peripheral neuropathy (CIPN) suggest that while there are no preventive therapies with significant clinical efficacy, the only agent recommended for painful CIPN is duloxetine. This indicates that while some treatments are considered safe, their effectiveness varies. ^{1 5 6 7 8}

How does usual care for CIPN differ from other treatments?

Usual care for chemotherapy-induced peripheral neuropathy (CIPN) involves standard medications and treatment adjustments like delaying or reducing chemotherapy doses, but there are no recommended preventive treatments for CIPN. Unlike novel agents being tested, such as HDAC6 inhibitors, usual care focuses on managing symptoms rather than preventing them. ^{1 5 6 9 10}

Research Team

Douglas Corley, MD, PhD

Principal Investigator

Division of Research, Kaiser Permanente Northern California

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Chemotherapy-induced peripheral neuropathy: where are we now? [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Newly identified chemotherapy-induced peripheral neuropathy in a childhood cancer survivorship clinic. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Impact of chemotherapy-induced peripheral neuropathy on treatment delivery in nonmetastatic breast cancer. [2022]

4. Netherlands 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. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Identifying participants' preferences for modifiable chemotherapy-induced peripheral neuropathy prevention clinical trial factors: an adaptive choice-based conjoint analysis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Chemotherapy-induced peripheral neuropathy: A current review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Association of Taxane Type With Patient-Reported Chemotherapy-Induced Peripheral Neuropathy Among Patients With Breast Cancer. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Mapping chemotherapy-induced peripheral neuropathy phenotype and health-related quality of life in patients with cancer through exploratory analysis of multimodal assessment data. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Patient-centric decision framework for treatment alterations in patients with Chemotherapy-induced Peripheral Neuropathy (CIPN). [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Nonpharmacologic Interventions for Chemotherapy-Induced Peripheral Neuropathy in Patients With Breast Cancer: A Systematic Review and Network Meta-analysis. [2023]