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

Trial Summary

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 data supports the effectiveness of the treatment mychoiceTM for cancer?

The research highlights the importance of shared decision-making tools in cancer treatment, which can improve patient involvement and decision quality. While not directly about mychoiceTM, these tools help patients make informed choices, potentially enhancing the effectiveness of treatments like mychoiceTM by aligning them with patient values and preferences. ^{1 2 3 4 5}

What safety data exists for the mychoiceTM Tool for Cancer?

The research articles provided do not contain specific safety data for the mychoiceTM Tool for Cancer. They focus on patient-reported outcomes and adverse event reporting in cancer trials, but do not mention mychoiceTM or its safety profile. ^{6 7 8 9 10}

What is the purpose of this trial?

This is a pragmatic, non-randomized mixed-methods evaluation study designed to evaluate the feasibility and acceptability of delivering the mychoiceTM tool to new Medical Oncology patients as well as to more deeply explore its value to patients in their discussion with their provider about clinical trials as a treatment option over the course of their oncology treatment (Effectiveness).

Research Team

Linda Fleisher, PhD, MPH

Principal Investigator

Fox Chase Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Ireland 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. [2012]

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

Decision making in oncology: a review of patient decision aids to support patient participation. [2022]

3. Scotland pubmed.ncbi.nlm.nih.gov

The effects of cancer clinical decision support systems on patient-reported outcomes: A systematic review. [2023]

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

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

5. Germany 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. [2018]

6. Netherlands 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). [2022]

7. England 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). [2022]

8. England 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. [2021]

9. United States 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. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Usability of an online application for reporting the burden of side effects in cancer patients. [2021]