Remote Monitoring for Breast and Prostate Cancer

(PROMOTE Trial)

Overseen By Tara Rosewall, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Significant comorbidities, others

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

Compensation: Varies

Number of Visits: 6

124 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for monitoring side effects in breast and prostate cancer patients undergoing radiation therapy (RT). Patients use a mobile app to report symptoms, enabling doctors to adjust the frequency of patient visits. The goal is to optimize patient care, potentially reducing hospital visits and catching side effects early to improve quality of life. This remote monitoring of patient-reported outcomes suits those diagnosed with breast or prostate cancer who are beginning outpatient RT at Princess Margaret Cancer Centre and can use a mobile app in English or French. As an unphased trial, this study allows patients to contribute to innovative research that could enhance cancer care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on using a mobile app to report side effects during radiation therapy.

What prior data suggests that using mobile phone applications for remote monitoring of patient-reported outcomes is safe?

Research has shown that remote monitoring to track patient well-being during cancer treatment is safe. Studies have found that this method reduces the likelihood of hospital visits for cancer patients, allowing them to avoid frequent trips while still being closely monitored.

Patients using mobile apps to report symptoms have felt better and experienced fewer physical issues during treatment. This suggests the system not only ensures safety but also enhances patient well-being.

Additionally, both patients and healthcare providers find these electronic systems easy to use and helpful, indicating that the technology is accepted and trusted by its users.

Overall, remote monitoring of patient-reported outcomes is well-received and has demonstrated positive results in managing cancer treatment side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the remote monitoring of patient-reported outcomes for breast and prostate cancer because it offers a more personalized and flexible approach to care. Unlike traditional treatments, which require regular in-person visits, this method uses a mobile app for patients to report their symptoms and needs. This allows healthcare providers to tailor follow-up care and potentially reduce unnecessary appointments. By leveraging technology, this approach aims to enhance patient satisfaction and streamline the management of radiation therapy side effects.

What evidence suggests that remote monitoring of patient-reported outcomes is effective for breast and prostate cancer?

Research has shown that mobile phone apps used to track patient experiences during and after radiation therapy can significantly enhance their experience. In this trial, participants in the remote monitoring arm will use these apps to report symptoms. One study found that patients using these apps had fewer hospital visits, reducing disruptions to their daily lives. Another study demonstrated that this tracking improved quality of life and reduced physical symptoms compared to regular care. When patients easily report symptoms, healthcare providers can respond quickly, leading to better management of side effects and potential cost savings. Overall, remote monitoring ensures patients receive necessary care without unnecessary doctor visits. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for outpatients at Princess Margaret Cancer Centre about to undergo radical or adjuvant radiation therapy for breast or prostate cancer. Participants must be able to use a mobile app in English or French to self-report their health outcomes.

Inclusion Criteria

I have been diagnosed with breast or prostate cancer.

I am scheduled for intensive radiation therapy as an outpatient at Princess Margaret Cancer Centre.

I can use a mobile app in English or French to enter my health information.

Exclusion Criteria

Significant comorbidities that would render the patient not suitable for remote monitoring

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive radiation therapy with weekly in-person reviews and remote monitoring of patient-reported outcomes

5 weeks

5 visits (in-person), weekly remote monitoring

Post-Radiation Follow-up

Participants are monitored for safety and effectiveness after radiation therapy, with a focus on remote monitoring and one in-person visit

12 weeks

1 visit (in-person), virtual follow-up as needed

What Are the Treatments Tested in This Trial?

Interventions

• Remote Monitoring of Patient Reported Outcomes

Trial Overview The study tests if using mobile apps for patients to report side effects (mPROs) and remote monitoring by healthcare providers can improve the timing and quality of patient care during and after radiation therapy.

How Is the Trial Designed?

Group I: Remote monitoring PROs Experimental Treatment 1 Intervention

All participants allocated to the interventional arm will receive the RT technique, dose and fractionation according to institutional standards. Once per week, participants will use a mobile phone 'app' to enter mPROs, and indicate a need for review for any other reason. The treatment Radiation Therapists will triage the participant to either attend or skip that week's on-treatment review based on this information and established criteria. After RT completion, Advanced Practice Radiation Therapists (apRTs) will triage the participant to receive a virtual follow-up visit when necessary. Participants will be seen once by a Radiation Oncologist 4 to 12 weeks after last radiation treatment. The participants will also complete the following questionnaires: 1) Baseline (patient factors); 2) 'During treatment' (review quality); 3) 'Post acute phase' (satisfaction with care). Circle-of-care HCP will comment on the impact of the PROMOTE process on the quality of care for that participant.

Group II: Standard of Care Active Control 1 Intervention

All participants allocated to the standard of care arm will receive all RT treatment activities according to institutional standards. Participants will attend the weekly in-person review session with a Radiation Oncologist during treatment and will be seen once between 4 and 12 weeks after last RT treatment. Documentation of radiation-related toxicity will be performed by the radiation HCPs according to standard of care. Participants will be asked to complete the following study questionnaires: 1) Baseline evaluation (patient factors); 2) 'During treatment' evaluation (need/usefulness of review); 3) 'Post acute phase' evaluation (satisfaction with care).

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

Remote patient monitoring using patient-generated health data can help assess and improve recovery for cancer patients undergoing complex urologic and gynecologic surgeries.

This integrative review highlights the potential benefits of remote monitoring in addressing postoperative symptoms and functional declines, although specific data on the effectiveness and implementation are not detailed in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrative review of remote patient monitoring in gynecologic and urologic surgical oncology. Perez, F., Nolde, M., Crane, TE., et al.[2023]

The use of electronic patient-reported outcome measures (ePROMs) in advanced breast cancer care, when combined with interventions from oncology clinical nurse specialists (CNSs), has been shown to enhance patient outcomes and experiences through effective remote symptom monitoring.

Oncology clinical nurse specialists play a vital role in implementing ePROMs, helping to address complex symptoms and improve the quality of life for patients with advanced breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic Patient Reported Outcome Measures for Optimal Remote Symptom Management in Advanced Breast Cancer: Embracing Digital Health Technology. Warren, M.[2023]

A pragmatic trial involving 2158 patients with early stage breast cancer found that remote proactive management of chemotherapy-related toxicities did not significantly reduce emergency department visits or hospital admissions compared to routine care.

While the intervention group reported slightly fewer grade 3 toxicities (48%) than the control group (58%), there were no significant differences in self-efficacy, anxiety, or depression, indicating that the remote management approach may not improve overall patient outcomes during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote, proactive, telephone based management of toxicity in outpatients during adjuvant or neoadjuvant chemotherapy for early stage breast cancer: pragmatic, cluster randomised trial. Krzyzanowska, MK., Julian, JA., Gu, CS., et al.[2021]

The Advanced Symptom Management System (ASyMS) significantly reduced symptom burden in patients undergoing adjuvant chemotherapy, keeping their symptoms at pre-treatment levels, while those receiving standard care experienced increased symptoms throughout treatment.

Patients using ASyMS reported better quality of life and lower anxiety levels compared to the control group, indicating that remote monitoring can enhance patient support during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real time remote symptom monitoring during chemotherapy for cancer: European multicentre randomised controlled trial (eSMART). Maguire, R., McCann, L., Kotronoulas, G., et al.[2021]

A study involving 21 complex general and urologic oncology surgery patients showed that remote telemonitoring of health data and patient-reported outcomes is feasible, with high adherence rates of 95% before surgery and 91% at discharge.

Despite high adherence, patients experienced significant declines in mobility and daily activities shortly after discharge, indicating the need for ongoing support and monitoring in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of perioperative remote monitoring of patient-generated health data in complex surgical oncology. Melstrom, LG., Zhou, X., Kaiser, A., et al.[2023]

A pilot study involving 13 patients and 5 oncology staff demonstrated that using an electronic patient-reported outcomes (ePRO) platform for monitoring symptoms in cancer patients is feasible, with a high compliance rate of 91% for weekly assessments.

The majority of participants found the ePRO app helpful, with 87% of patients and 100% of staff expressing a willingness to use it frequently, indicating strong potential for improving symptom management in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot project investigating the use of ONCOpatient®-An electronic patient-reported outcomes app for oncology patients. Macanovic, B., O'Reilly, D., Harvey, H., et al.[2023]

Remote real-time monitoring systems for cancer patients show promise in improving clinical outcomes like pain, depression, and fatigue, despite significant methodological weaknesses in the studies reviewed.

There is a need for more rigorous research to evaluate these monitoring systems, as current studies lack control groups and health economic analyses, limiting the ability to compare results across different systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of remote real-time side-effect monitoring systems for patients receiving cancer treatment. Kofoed, S., Breen, S., Gough, K., et al.[2020]

A pilot study involving 26 patients with breast or colorectal cancer demonstrated that real-time mobile phone monitoring of symptoms during capecitabine treatment allowed for safe and effective dose adjustments, with an average dose intensity of 90% of the standard dose.

The system enabled timely management of chemotherapy side effects, as 46.2% of patients experienced moderate to severe toxicity, and both patients and healthcare professionals reported feeling reassured by the monitoring process, especially during off-hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study: dose adaptation of capecitabine using mobile phone toxicity monitoring - supporting patients in their homes. Weaver, A., Love, SB., Larsen, M., et al.[2022]

A web-based interface (WBI) for patient symptom self-reporting during chemoradiation therapy was found to be feasible and well-received, with 92% of patients reporting easy access to the surveys.

Despite high satisfaction, survey fatigue was noted, as 58% of patients felt the surveys were too long or frequent, suggesting a need for a more patient-centered approach to improve engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Symptom Monitoring With Patient-Reported Outcomes During Definitive Radiation Therapy With Chemotherapy (SYMPATHY): A Prospective Single-Center Phase 1 Study. Ma, TM., Yang, T., Philipson, R., et al.[2023]

Citations

1. redjournal.org redjournal.org/article/S0360-3016(24)01599-2/fulltext

Remotely Monitoring Patient-Reported Outcomes during ... To examine the feasibility of using a mobile phone app to remotely monitor patient-reported outcomes (PROs) during and immediately after radiation therapy (RT)

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2833891

Remote Symptom Monitoring With Electronic Patient ... This nonrandomized controlled trial found that RSM implementation was associated with reduced risk of hospitalizations for patients with cancer.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749208123001171

Effects of Patient-Reported Outcome Tracking and Health ... Compared to standard care, remote patient monitoring via RPMS was related to greater quality of life and lower physical symptom burden during cancer therapy.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06274892/remote-monitoring-of-patient-reported-outcomes-to-improve-the-efficacy-of-the-acute-phase-radiotherapy-review-process

Remote Monitoring of Patient Reported Outcomes to ... Hence, remotely monitoring mPROs to shape RT supportive care processes may reduce costs for patients and improve efficiency for physicians ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12357184/

Electronic Patient-Reported Outcomes With Vital Sign ... Throughout 24 weeks, the EORTC QLQ-C30 response rate was 99.6% in the monitoring group and 94.8% in the usual care group. Both the PRO-CTCAE ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10704259/

Patient-reported outcomes used actively in cancer ... This mini-review gives an overview of how ePRO solutions are tested in oncological research in Denmark and embraced by patients and clinicians.

7. mdpi.com mdpi.com/2306-5354/11/8/846

Remote Symptom Alerts and Patient-Reported Outcomes ... Symptom surveillance using a remote symptom monitoring (RSM) platform enables the capture and reporting of patient-reported outcomes (PROs) from home.

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2019.37.15_suppl.e18068

Remote patient monitoring using smart phone derived ... Remote patient monitoring using smart phone derived patient reported outcomes and Fitbit data to enable longitudinal predictive modeling in ...