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

Trial Summary

What is the purpose of this trial?

Radiation therapy (RT) is a key component in the treatment of breast and prostate cancer. However, patients may experience significant side effects. Patients can accurately self-report side effects from RT and these patient-reported outcomes (PROs) can direct communication between patient and healthcare provider (HCP), and facilitate joint decision making. Patients state that using mobile phone applications (apps) to collect PROs (mPROs) is easily incorporated into their daily routines, allowing them to engage at a time and pace that suits them. When mPRO collection is combined with remote symptom monitoring by HCPs, these systems result in improvements in symptom control and quality of life. Currently, patients receiving RT are seen by a Radiation Oncologist once per week during RT and once every few months after RT has finished. Recent evaluations indicate that patients and physicians consider the number of visits to be too frequent during RT, and too infrequent immediately after RT. This research will use weekly mPROs (remotely monitored by RT HCP) to determine if a patient needs (or wants) to be seen by a RT HCP during and/or immediately after RT. Using mPROs to optimize RT patient assessment processes will ensure patients are seen if and when required. For a patient, this could result in reduced time and costs at the hospital. For the physician, resources could be re-allocated to improve access to RT services. Using mPROs after RT has the potential for earlier treatment of side effects, which has been linked to improved survival and quality of life.

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 data supports the effectiveness of the treatment Remote Monitoring of Patient Reported Outcomes for breast and prostate cancer?

Research shows that remote monitoring of symptoms during cancer treatment can help manage side effects, improve quality of life, and reduce anxiety. This approach has been effective in other cancer treatments, suggesting it could be beneficial for breast and prostate cancer patients as well. ^{1 2 3 4 5}

Is remote monitoring safe for cancer patients?

Remote monitoring systems for cancer patients have shown promising results in improving clinical outcomes like pain and fatigue, and they are generally considered acceptable and safe. However, more rigorous studies are needed to confirm these findings and ensure patient safety. ^{1 2 3 6 7}

How is the Remote Monitoring of Patient Reported Outcomes treatment different from other treatments for breast and prostate cancer?

This treatment is unique because it uses digital technology to remotely monitor patients' symptoms and health data, allowing for real-time adjustments and support without needing frequent in-person visits. It focuses on patient-reported outcomes, which means patients actively report their symptoms and experiences, helping to tailor their care more precisely. ^{1 2 3 8 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

References

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

A pilot project investigating the use of ONCOpatient®-An electronic patient-reported outcomes app for oncology patients. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Real time remote symptom monitoring during chemotherapy for cancer: European multicentre randomised controlled trial (eSMART). [2021]

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

Feasibility of perioperative remote monitoring of patient-generated health data in complex surgical oncology. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

A pilot study: dose adaptation of capecitabine using mobile phone toxicity monitoring - supporting patients in their homes. [2022]

5. United States 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. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Benefits of remote real-time side-effect monitoring systems for patients receiving cancer treatment. [2020]

7. England 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. [2021]

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

Integrative review of remote patient monitoring in gynecologic and urologic surgical oncology. [2023]

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

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