Decision Aid Web Tool for Kidney Cancer

Overseen By Samantha Sanger

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Stage IV cancer, others

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

Compensation: Varies

Number of Visits: 2

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist patients with kidney tumors in making informed treatment decisions. Researchers are developing a web tool called a Decision Aid (DA) to provide personalized information on the benefits and risks of various treatments. Participants will either use this web tool or receive an informational pamphlet from the hospital. Suitable candidates have localized kidney tumors up to 4 cm and are already scheduled for exams at NYU Urology. As an unphased trial, this study allows participants to contribute to developing a tool that could significantly enhance decision-making for future patients.

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 this decision aid is safe for patients with kidney cancer?

Research has shown that tools assisting patients in making treatment decisions are generally safe. These tools provide clear information about different options. Studies have found that these aids help people understand the risks and benefits of various treatments without causing harm.

In one study, patients used a web-based tool to decide on treatment for kidney cancer. The study found that patients could make informed choices about their care, and there were no reports of the tool causing harm or side effects.

Overall, decision aids like the one in this study are well-received. They aim to improve understanding and help patients feel confident in their healthcare decisions without adding new health risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Decision Aid Web Tool for kidney cancer because it empowers patients with personalized information to help them make informed decisions about their treatment options. Unlike traditional methods like pamphlets, which provide generic information, this web tool offers a tailored experience that considers individual patient preferences and medical history. By enhancing patient understanding and involvement in their treatment plans, this tool could lead to better patient satisfaction and potentially improved outcomes.

What evidence suggests that this decision aid is effective for kidney cancer?

This trial will compare the effectiveness of a Decision Aid (DA) Web Tool with an Institutional Pamphlet for kidney cancer treatment decision-making. Research has shown that decision aids (DAs) can help patients make better treatment choices for kidney cancer. One study found that online decision aids improved patients' understanding of their treatment options, enabling choices that align with their personal values. Another study demonstrated that using a decision aid in kidney cancer treatment led to more informed and satisfying decisions for patients. Additionally, patients have accepted these tools and found them easy to use, indicating their effectiveness in real-life situations. Overall, decision aids help patients make well-informed decisions about their kidney cancer treatment. ^{1 2 6 7 8}

Who Is on the Research Team?

Stella Kang, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for men and women over 18 who are seeing a urologist at NYU for kidney tumors no larger than 4 cm. It's open to patients before and after surgery but not to those with stage IV cancer or anyone unable to consent.

Inclusion Criteria

I am 18 or older with a kidney tumor no larger than 4 cm.

You have appointments for regular medical check-ups at the NYU Urology Department.

Exclusion Criteria

Inability to provide informed consent

Vulnerable subjects will not be recruited

My cancer is at stage IV.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Counseling and Decision Aid

Participants use the decision aid (DA) to understand treatment options and make informed decisions about their kidney masses

1 day

1 visit (in-person)

Follow-up

Participants are monitored for decision satisfaction and shared decision making outcomes

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Decision Aid (DA)

Trial Overview The study is testing a new web tool called Decision Aid (DA) against the usual information pamphlets given by hospitals. The DA aims to help kidney tumor patients understand their treatment options better.

How Is the Trial Designed?

Group I: Decision Aid (DA) Web Tool Experimental Treatment 1 Intervention

Group II: Institutional Pamphlet Active Control 1 Intervention

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

In a study involving 382 newly diagnosed prostate cancer patients, those who used a decision aid (DA) were significantly more likely to choose active surveillance (AS) as a treatment option compared to those who did not use the DA (29% vs 16%).

Patients using the DA who were not eligible for AS opted for surgery more frequently than the control group (53% vs 35%), indicating that the DA influenced treatment decisions by helping patients clarify their preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in treatment choices between prostate cancer patients using a decision aid and patients receiving care as usual: results from a randomized controlled trial. Lamers, RED., Cuypers, M., de Vries, M., et al.[2022]

A novel interactive visualization tool based on the IMDC criteria was developed and tested, showing that it can effectively help both lay-users and physicians estimate median survival times for patients with metastatic kidney cancer, using data from over 4,500 patients.

User testing revealed that the tool improved accuracy in prognosis calculations, especially for physicians, with 93% expressing interest in using the updated version clinically, indicating its potential for enhancing shared decision-making in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive Data Visualization Tool for Patient-Centered Decision Making in Kidney Cancer. Shee, K., Pal, SK., Wells, JC., et al.[2021]

A study of 73 patients with small renal masses showed that while most had low decisional conflict after counseling, there was a significant lack of disease knowledge, indicating a need for improved patient education.

Patients experiencing higher decisional conflict reported lower satisfaction with their care and felt less involved in the decision-making process, highlighting the importance of effective communication and shared decision-making in treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decisional Quality in Patients With Small Renal Masses. Shirk, JD., Laviana, A., Lambrechts, S., et al.[2019]

A patient decision aid (DA) for small kidney masses significantly improved patient knowledge about risks and treatment options, with scores increasing from 22.3% to 52.6% compared to standard educational materials.

The DA also encouraged more patients to discuss ablation as a treatment option, with 66.7% of DA users discussing it compared to only 18.2% of those using standard materials, indicating its effectiveness in promoting informed decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Pilot Evaluation of a Decision Aid for Small Kidney Masses. Thomas, SA., Siriruchatanon, M., Albert, SL., et al.[2023]

A survey of 600 urologists in Germany revealed that while 98% are familiar with the EAU guidelines for managing renal cell cancer (RCC), follow-up practices often do not align with these recommendations, particularly regarding imaging protocols.

Only 84% of patients with metastatic RCC were offered systemic therapy, indicating a potential gap in treatment for this patient population despite the availability of established guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Usage of Different Guidelines in Routine Management, Therapy and Follow-Up of Patients with Renal Cell Cancer in Germany. Spek, A., Szabados, B., Ziegelmüller, B., et al.[2017]

A new evidence-based decision aid was developed to help patients with localized renal masses make informed choices between partial and radical nephrectomy, meeting high standards for quality and certification.

The decision aid was well-received by users, with 91% of respondents finding the language acceptable and 82% appreciating its length, indicating it is a useful tool for facilitating shared decision-making in urology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and acceptability testing of a patient decision aid for individuals with localized renal masses considering surgical removal with partial or radical nephrectomy. McAlpine, K., Breau, RH., Stacey, D., et al.[2020]

A study involving 160 participants, including patients with newly diagnosed breast, advanced-stage prostate, and advanced-stage lung cancer, found that a decision aid significantly improved understanding and involvement in treatment decisions for both patients and their caregivers.

The decision aid facilitated a shared decision-making process, leading to more satisfying treatment choices and highlighting the importance of caregiver involvement in understanding treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capturing treatment decision making among patients with solid tumors and their caregivers. Jones, RA., Steeves, R., Ropka, ME., et al.[2021]

In a study of 81 patients with renal cell carcinoma, follow-up care was largely in line with guideline recommendations, with 72% of patients monitored by urologists using various imaging and diagnostic methods.

Only 12.5% of patients sought psycho-oncological support, indicating a potential gap in addressing the psychological needs of patients post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of guideline recommendations with daily practice in patients with renal cell carcinoma. Schlenker, B., Seitz, M., Bader, MJ., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9482069/

An Evaluation of a Web-Based Decision Aid for Treatment ... This pilot randomized controlled trial (RCT) primarily aims to evaluate the impact of a new web-based DA on treatment decisions for patients with SKM.

2. ascopubs.org ascopubs.org/doi/10.1200/CCI.21.00050

Interactive Data Visualization Tool for Patient-Centered ... We sought to develop a novel data visualization tool for kidney cancer outcomes, and perform usability testing in nonmedical and medical users. ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11963785/

Interactive decision aid on therapy decision making for ... This study aimed to evaluate the effectiveness of an Interactive Patient-Decision-Aid App for Kidney Replacement Therapy (iPtDA-KRT App) in improving decision ...

4. euoncology.europeanurology.com euoncology.europeanurology.com/article/S2588-9311(24)00212-8/fulltext

Evaluating the Impact of a Shared Decision-making ... We are conducting a trial on the effects of a tool to support shared decision-making by patients with kidney cancer who are facing treatment ...

5. auajournals.org auajournals.org/doi/full/10.1097/UPJ.0000000000000830

Development of a Patient Decision Aid for cT1 Renal Masses The aim of this study was to develop a Dutch PtDA for cT1 renal masses and to test its acceptability and usability.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0738399125001673

Improving value of care for renal cell carcinoma patients We designed a decision aid (PtDA) for use in treatment decision-making. This tool can help RCC patients to make informed, value-consistent treatment decisions.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10351331/

A CLINICAL DECISION AID TO SUPPORT PERSONALIZED ... We present a risk calculator that generates personalized estimates of the risks of death from cancer or other causes and complications for ...

8. bjui-journals.onlinelibrary.wiley.com bjui-journals.onlinelibrary.wiley.com/doi/full/10.1002/bco2.70014

Feasibility study of using the PREDICT kidney tool for patients ... The tool uses the Leibovich score augmented with English national data to provide a personalised risk assessment of cancer recurrence and death ...