Smartphone App for Post-Surgery Care in Bladder Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan Rogel Cancer Center

Disqualifiers: Non-English speaking, No smartphone

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app called the CLEAR Care Companion (CC) application to assist individuals who have undergone bladder cancer surgery. The app tracks symptoms post-surgery and provides education to determine if it can reduce hospital readmissions and improve communication with doctors. Suitable participants have had a radical cystectomy (bladder removal surgery) and have access to a smartphone or tablet. Those treated at the University of Michigan who fit this profile might consider joining. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance post-surgery care for future patients.

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

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

What prior data suggests that this smartphone app is safe for post-surgery care in bladder cancer patients?

Research has shown that while specific safety data for the CLEAR Care Companion app is not available, understanding its function is crucial. The app aims to enhance communication between patients and doctors following bladder cancer surgery. Unlike drugs or medical devices that enter the body, it does not carry the same risks.

Digital tools like this app are generally safe, as they help patients manage health information. They assist in tracking symptoms and provide educational support, which can improve communication with doctors and potentially reduce hospital visits.

Health monitoring apps on smartphones are typically well-tolerated since they do not involve medication or procedures. The primary concern may be the app's usability or functionality. However, in terms of safety, there is little risk of harm from using the app itself. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CLEAR Care Companion app because it offers a new way to support bladder cancer patients after surgery. Unlike traditional post-surgery care, which often involves frequent in-person follow-ups and manual tracking of symptoms, this app provides a convenient, digital platform for monitoring recovery. Patients can use their smartphones or tablets to receive personalized care instructions, symptom tracking, and communication with healthcare providers. This approach aims to enhance patient engagement and potentially improve recovery outcomes by making it easier to manage care from home.

What evidence suggests that the CLEAR Care Companion application is effective for post-surgery care in bladder cancer?

Research has shown that smartphone apps can aid in better recovery after surgery. In this trial, participants will use the CLEAR Care Companion app, designed to track symptoms and educate patients following bladder cancer surgery. The app aims to reduce hospital readmissions, a common occurrence after major cancer surgeries. By enhancing communication between patients and healthcare providers, the app may help identify problems early, allowing for quicker treatment. Early indications suggest that these digital tools can improve patient satisfaction and reduce complications. ^{1 2 3 5 6}

Who Is on the Research Team?

Jeffery Montgomery, M.D.

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

This trial is for English-speaking bladder cancer patients at the University of Michigan who are undergoing radical cystectomy. Participants must have access to a smartphone or tablet with internet to use the CLEAR Care Companion app.

Inclusion Criteria

I am having bladder removal surgery with reconstruction.

Access to compatible smartphone or tablet device

Patient at the University of Michigan (Michigan Medicine)

Exclusion Criteria

Patients without access to a smart phone or tablet with internet capacity

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Postoperative Monitoring

Participants use the CLEAR Care Companion application to track postoperative symptoms and engage with educational interventions

6 weeks

Continuous engagement via smartphone application

Follow-up

Participants are monitored for safety and effectiveness after using the application, focusing on readmission rates and patient satisfaction

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CLEAR Care Companion (CC) application

Trial Overview The study tests if a smartphone application, which tracks symptoms and provides educational content after major cancer surgery, can improve communication with doctors, patient satisfaction, and reduce hospital readmissions.

How Is the Trial Designed?

Group I: CLEAR CC Experimental Treatment 1 Intervention

Patients use CLEAR CC application with Smartphone or Tablet

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+

Published Research Related to This Trial

A scoping review of 10 studies involving cancer patients identified various predictors of adherence to mHealth apps, but no definitive predictor for increased app usage was established.

The review highlights the need for further research into usage patterns to enhance the design and effectiveness of mHealth interventions in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Adherence to Cancer-Related mHealth Apps in Cancer Patients Undergoing Oncological or Follow-Up Treatment-A Scoping Review. Armbruster, C., Knaub, M., Farin-Glattacker, E., et al.[2023]

The I-Can Manage program was developed through a user-centered co-design process involving 16 cancer patients and 19 clinicians, focusing on self-management of treatment toxicities with evidence-based content and features tailored to patient needs.

Usability testing showed high patient satisfaction with the program, indicated by a mean score of 3.75 on the Post-Study System Usability Questionnaire, suggesting it effectively supports patients in managing their cancer treatment side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web-Based Cancer Self-Management Program (I-Can Manage) Targeting Treatment Toxicities and Health Behaviors: Human-Centered Co-design Approach and Cognitive Think-Aloud Usability Testing. Howell, D., Bryant Lukosius, D., Avery, J., et al.[2023]

Patients in surgical oncology express a strong need for better educational resources, indicating a gap in perioperative information.

Both patients and providers support the use of a mobile application to enhance patient education, although providers initially see patient onboarding as a potential burden; however, they believe it could ultimately streamline workflows and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and provider perceptions on utilizing a mobile technology platform to improve surgical outcomes in the perioperative setting. Huynh, B., Barrett, J., Joachim, A., et al.[2021]

A digital monitoring application was developed through collaborative design with patients and health professionals to support colorectal cancer patients during the first 30 days post-surgery, aiming to improve patient care and outcomes.

The app allows patients to report concerns to healthcare providers, which can help in early identification of issues, reduce readmission rates, and enhance recovery experiences by providing timely support and relevant information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Remote Monitoring Application to Improve Care and Support Patients in the First 30 Days Following Colorectal Cancer Surgery. Miller, M., Roxburgh, CS., McCann, L., et al.[2023]

The self-assessment smartphone app alerted 72.6% of users about concerning symptoms related to tobacco-induced diseases, with current smokers showing a higher incidence of symptoms like fatigue and cough, indicating a significant awareness of health issues.

During the study, the incidence of early-stage lung cancer (stages 1 and 2) increased to 24% among users, compared to 9% in the previous year, suggesting that the app may enhance early detection of lung cancer and encourage smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Smartphone Self-assessment App for a Tobacco-Induced Disease (COPD, Cardiovascular Diseases, Cancer) Screening Strategy and to Encourage Smoking Cessation: Observational Study. Stavaux, E., Goupil, F., Barreau, G., et al.[2023]

The pilot study involving 23 female breast cancer survivors demonstrated that an app-based interactive care plan (ICP) was feasible, allowing for remote monitoring and symptom management, although patient engagement fell short of the desired 75% completion rate for tasks.

Despite the initial feasibility, with all patients engaging in at least one task, the decreasing completion rates over time indicate a need for strategies to improve ongoing patient engagement and enhance the effectiveness of the ICP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot implementation to assess the feasibility and care team impact of an app-based interactive care plan to remotely monitor breast cancer survivors. Stan, DL., Inselman, JW., Ridgeway, JL., et al.[2022]

A study involving 4475 breast cancer patients showed that using a smartphone app significantly improved adherence to multidisciplinary treatment (MDT) recommendations, with a notable reduction in noncompliance rates from 27.4% in 2013 to 8.8% in 2019.

Patients who used the app were 39% less likely to deviate from MDT recommendations compared to those who did not use the app, particularly improving compliance with adjuvant chemotherapy and radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Smartphone-Based App to Improve Adjuvant Treatment Adherence to Multidisciplinary Decisions in Patients With Early-Stage Breast Cancer: Observational Study. Yu, J., Wu, J., Huang, O., et al.[2021]

The use of a mobile health patient engagement technology (PET) in gynecologic oncology patients led to a significant reduction in hospital length of stay (LOS), averaging 2.9 days compared to 3.6 days in the control group.

Patients using the PET also experienced a 50% lower readmission rate (4.3% vs. 8.6%), indicating that the technology effectively improved postoperative outcomes and patient engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a mobile health patient engagement technology improves perioperative outcomes in gynecologic oncology patients. Boitano, TKL., Gardner, A., Chu, DI., et al.[2023]

The web-based application ePATH was found to be user-friendly and effective in supporting self-care for 15 men recovering from prostate cancer surgery, providing easy access to reliable rehabilitation information.

Patients appreciated the tailored information and logical structure of ePATH, but noted that unclear organization could decrease their motivation to use the app, highlighting the importance of clear design in digital health tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' experiences of using an e-Health tool for self-management support after prostate cancer surgery: a deductive interview study explained through the FITT framework. Nilsson, L., Hellström, A., Wennerberg, C., et al.[2021]

This study will evaluate the effectiveness of the MobiMD mobile app in reducing hospital readmissions for 300 patients who have undergone complex abdominal surgery, comparing it to standard care.

The app allows for daily monitoring of vital signs and symptoms, with the goal of improving transitional care and potentially lowering readmission rates within 30 days post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for the MobiMD trial: A randomized controlled trial to evaluate the effect of a self-monitoring mobile app on hospital readmissions for complex surgical patients. Diehl, TM., Barrett, JR., Abbott, DE., et al.[2023]

The NCCN Third Annual Patient Safety Summit focused on improving patient safety in oncology by addressing medication reconciliation, communication during patient hand-offs, and reporting near-miss events, highlighting the importance of these processes in preventing adverse events.

Key strategies discussed included transitioning from paper to electronic systems and enhancing education and training for healthcare teams, emphasizing that every team member plays a crucial role in maintaining patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Report on the NCCN Third Annual Patient Safety Summit. Hinkel, JM.[2019]

Citations

1. bcan.org bcan.org/clinicaltrials/clear-care-companion-application/

CLEAR Care Companion Application BRIEF SUMMARY. Hospital readmissions are common after major cancer surgery, leading to poorer patient outcomes, increased mortality and additional costs. In ...

2. withpower.com withpower.com/trial/phase-urinary-bladder-neoplasms-9-2022-eead5

Smartphone App for Post-Surgery Care in Bladder Cancer In this study, Clinical and Engineering Approaches to Readmission (CLEAR) Care Companion Application, investigators aim to utilize a smartphone application ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11657902/

A novel smartphone application for bladder cancer ... This study aimed to design, develop, and evaluate a smartphone application to assist urologists in managing bladder cancer (BCM App).

4. mdpi.com mdpi.com/2227-9032/11/6/886

Effectiveness of Transition Care Intervention Targeted to ... We describe the methods of a trial that aims to evaluate the effect of a structured multimodal transitional care intervention targeted to higher-risk medical ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2590137025000780

Digital sensing technologies in cancer care: A new era in ... This review explores the landscape of digital sensor platforms in the context of cancer diagnosis, providing an overview of their principles, functionalities, ...

6. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/cancer

Cancer Clinical Trials The purpose of this study is to address the gaps in data completeness regarding treatment toxicities, patient reported outcomes, and biometric information. Hugo ...