mychoiceTM Tool for Cancer

Overseen By Zoe Landau, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fox Chase Cancer Center

Disqualifiers: Non-English speakers, No cancer diagnosis

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

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates a tool called mychoiceTM, designed to help cancer patients have better discussions with their doctors about clinical trials as a treatment option. It focuses on assessing the tool's usefulness and acceptability for patients during cancer treatment. All participants will receive the mychoiceTM tool to observe its impact on their conversations and decisions. This trial suits individuals who have seen a medical oncologist, have a cancer diagnosis, can speak and read English, and have a phone number or email on file. As an unphased trial, it offers a unique opportunity for patients to contribute to developing tools that can enhance their treatment experience.

Will I have to stop taking my current medications?

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

What prior data suggests that the mychoiceTM tool is safe for use in oncology patients?

Research shows that the mychoiceTM tool assists cancer patients in making decisions. It is not a drug or treatment but an educational tool that facilitates discussions between patients and doctors about clinical trial options.

As mychoiceTM is a tool rather than a medication, it does not pose safety concerns like those associated with new drugs. It enhances patients' understanding of their choices. Studies have shown that patients receive tools like this well, often feeling more prepared to engage with their doctors. The tool aims to make these conversations easier and more effective.

Regarding safety, using mychoiceTM is considered very safe because it serves as an informational aid, not something that affects the body. No reports of negative effects have emerged from its use. It focuses on helping people become more informed about their treatment options. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The mychoiceTM tool for cancer is unique because it aims to personalize cancer treatment by analyzing a patient's specific genetic makeup. Unlike traditional cancer treatments that often use a one-size-fits-all approach, mychoiceTM identifies genetic factors that influence how a patient might respond to certain therapies, potentially improving treatment outcomes. Researchers are excited about this tool because it could lead to more targeted and effective treatments, minimizing unnecessary side effects and providing a more tailored approach to cancer care.

What evidence suggests that the mychoiceTM tool is effective for cancer patients?

Research shows that the mychoiceTM tool helps cancer patients make informed decisions about joining clinical trials. Studies have found that tools like mychoiceTM enable patients to better understand their options and feel more prepared to discuss them with their doctors. One study highlighted how the tool improves informed decision-making and enhances communication with patients. Early findings suggest that patients using mychoiceTM feel more confident in choosing their treatment paths. While no direct evidence links it to cancer treatment, the tool plays a crucial role in supporting patient decisions, which is key for personalized treatment strategies. ^{1 6 7 8 9}

Who Is on the Research Team?

Linda Fleisher, PhD, MPH

Principal Investigator

Fox Chase Cancer Center

Are You a Good Fit for This Trial?

This trial is for adult cancer patients who have already had their first medical oncology visit. Participants must be able to speak and read English and have a cell phone number or email on record. It's not for those without a cancer diagnosis or who cannot understand English.

Inclusion Criteria

I have had my first visit with a cancer specialist.

My contact information is updated in my medical records.

Able to speak and read English

Exclusion Criteria

I do not have a cancer diagnosis.

I cannot speak or read English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the mychoiceTM tool and complete a quality improvement survey

6 months

Online interaction

Follow-up

Participants are monitored for the impact of the mychoiceTM tool on their preparedness to discuss clinical trials

24 months

What Are the Treatments Tested in This Trial?

Interventions

• mychoiceTM

Trial Overview The study is testing the mychoiceTM tool, which helps cancer patients discuss clinical trials as treatment options with their providers. The focus is on how feasible and acceptable this tool is when given to new oncology patients.

How Is the Trial Designed?

Group I: mychoiceTM intervention Experimental Treatment 1 Intervention

Single arm study - all participants receive mychoiceTM

Who Is Running the Clinical Trial?

Fox Chase Cancer Center

Lead Sponsor

Trials

236

Recruited

39,300+

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Published Research Related to This Trial

In a multicenter clinical trial involving 152 lung cancer patients, the use of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) allowed for high compliance in self-reporting adverse events, particularly during treatment (86% compliance).

The study demonstrated that patients were willing to self-report their symptoms using tablet computers, and identified that improving data collection methods, such as allowing electronic reporting between visits, could further enhance compliance and data quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Patient Reporting of Symptomatic Adverse Events via the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial. Basch, E., Pugh, SL., Dueck, AC., et al.[2022]

A survey of 727 stakeholders in cancer clinical research revealed that 93% believe patient-reported outcomes (PROs) for adverse events would enhance understanding of patient experiences during treatment.

The majority of respondents (88%) felt that using the PRO-CTCAE would improve the quality and efficiency of symptom data collection, indicating strong support for its implementation in clinical trials to inform treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stakeholder perspectives on implementing the National Cancer Institute's patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Bruner, DW., Hanisch, LJ., Reeve, BB., et al.[2022]

A systematic review of 15 studies found that Decision Support Systems (DSS) were effective in reducing worst and usual pain scores for cancer patients, indicating some benefit in symptom management during and after treatment.

However, DSS interventions showed mixed results for improving overall health-related outcomes like quality of life and depression, highlighting the need for better evaluation methods to understand their full impact on patient-reported outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of cancer clinical decision support systems on patient-reported outcomes: A systematic review. Pitt, E., Bradford, N., Robertson, E., et al.[2023]

The Choice interactive tailored patient assessment tool (ITPA) significantly increased the number of cues and concerns expressed by cancer patients during consultations, with 473 cues and 109 concerns identified in the experimental group compared to the control group.

While the Choice ITPA effectively helped patients communicate their issues, it highlighted the need for additional communication skills training for clinicians to enhance their responses and provide more patient-centered care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an interactive tailored patient assessment tool on eliciting and responding to cancer patients' cues and concerns in clinical consultations with physicians and nurses. Heyn, L., Ruland, CM., Finset, A.[2012]

The study involved 127 cancer patients undergoing chemotherapy or radiation therapy, and it confirmed that most adverse event (AE) terms in the PRO-CTCAE library were easily understood by patients, regardless of their education level.

Minor modifications were made to 17 AE terms to enhance clarity and comprehension, ultimately supporting the content validity of the PRO-CTCAE for accurately capturing patient-reported outcomes during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive interviewing of the US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Hay, JL., Atkinson, TM., Reeve, BB., et al.[2022]

In a meta-analysis of 143 phase 3 randomized controlled trials involving 88,603 patients with advanced cancers, experimental drugs showed improved progression-free survival (PFS) and overall survival (OS) compared to control groups, with hazard ratios of 0.80 and 0.87, respectively.

However, these experimental treatments were associated with higher rates of toxic deaths, treatment discontinuations without progression, and severe adverse events, indicating that while they may be more effective, they also come with increased safety risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, safety and tolerability of drugs studied in phase 3 randomized controlled trials in solid tumors over the last decade. Ribnikar, D., Goldvaser, H., Veitch, ZW., et al.[2021]

The web application BijKanker was well-received by patients, with 61% completing the initial questionnaire and 40% providing feedback after four months, indicating a positive user experience in reporting side effects during cancer treatment.

Patients reported a total of 1661 side effects, highlighting the application's effectiveness in capturing patient-reported outcomes, which can enhance communication with healthcare providers and improve patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability of an online application for reporting the burden of side effects in cancer patients. van Eenbergen, MC., van den Hurk, C., Mols, F., et al.[2021]

A systematic review of 23 randomized trials found that cancer patient decision aids significantly improve patient participation in decision making and lead to higher-quality decisions regarding treatment options.

Effective strategies to enhance shared decision making include training clinicians, using question prompt sheets, and providing decision coaching, which can help address patients' knowledge gaps and unrealistic expectations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision making in oncology: a review of patient decision aids to support patient participation. Stacey, D., Samant, R., Bennett, C.[2022]

Involving cancer patients in the decision-making process about their treatment can significantly reduce their feelings of uncertainty, decisional conflict, and regret.

To achieve high-quality decisions, healthcare providers should ensure patients are well-informed about their diagnosis, prognosis, and treatment options, while also helping them clarify their personal values and preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Patient Uncertainty: Implementation of a Shared Decision-Making Process Enhances Treatment Quality and Provider Communication. Gustafson, A.[2017]

In a study of 126 cancer patients, nearly half preferred shared decision-making with their doctors, while others either wanted to leave decisions to their physician or take full control themselves, highlighting diverse preferences in treatment decision control.

Factors such as older age and higher distress levels were linked to a greater tendency to defer decision-making to physicians, suggesting that understanding these preferences can help oncologists tailor their approach to patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer patients' control preferences in decision making and associations with patient-reported outcomes: a prospective study in an outpatient cancer center. Schuler, M., Schildmann, J., Trautmann, F., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06222242

mychoiceTM Implementation With Medical Oncology Patients The primary outcome will be to measure the effectiveness of the tool using a modified Ottawa Preparation Scale (PrepDM, 1-5 scale) addressing the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10558017/

'My Choices, My Wishes' Program and Its Effect on ... The outcomes measured were the number of stage IV cancer ... Collaboration with all members of the team, tracking financial gain, and ongoing tools for ...

3. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT06222242?keyword=%22CANCER%22

mychoiceTM Implementation With Medical Oncology Patients This is a pragmatic, non-randomized mixed-methods evaluation study designed to evaluate the feasibility and acceptability of delivering the mychoiceTM tool ...

4. researchgate.net researchgate.net/publication/384468843_Exploring_Racial_Disparities_in_Awareness_and_Perceptions_of_Oncology_Clinical_Trials_Cross-Sectional_Analysis_of_Baseline_Data_From_the_mychoice_Study

Exploring Racial Disparities in Awareness and Perceptions ... ... mychoice communication tool to prepare patients and improve informed decision making regarding clinical trial participation. Article. Oct 2019.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0738399125007062

Interventions to support patient decision making about ... This review highlights the potential utility of tools for patients considering health research participation, providing an overview of resources ...

6. trialx.com trialx.com/clinical-trials/listings/283229/mychoicetm-implementation-with-medical-oncology-patients/

mychoiceTM Implementation With Medical Oncology Patients Our goal is to conduct follow-up with those patients who used mychoiceTM to evaluate the impact of the tool on patients' perceived preparedness ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/P190014B.pdf

summary of safety and effectiveness data (ssed) The myChoice CDx device determines a patient's Myriad HRD Status by detecting single nucleotide variants (SNVs), variants in homopolymer ...

8. aacrjournals.org aacrjournals.org/cebp/article/32/1_Supplement/B007/712347/Abstract-B007-mychoiceTM-User-Testing-Insights

Abstract B007: mychoice TM User-Testing – Insights from ... mychoice TM is a novel, culturally tailored online CT education tool designed to foster shared decision making between patients (pts) and their providers.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10509046/

Utilizing the MyCareCompass Platform to Deliver Patient ... It offers multiple educational modules for patients undergoing infusion chemotherapy, immunotherapy, port-insertion, and surgical ostomies.