Remote Monitoring of Patient Reported Outcomes to Improve the Efficacy of the Acute Phase Radiotherapy Review Process

Trial Title: Remote Monitoring of Patient Reported Outcomes to Improve the Efficacy of the Acute Phase Radiotherapy Review Process

NCT ID: NCT06274892

Condition: Prostate Cancer
Breast Cancer

Conditions: Official terms:
Prostatic Neoplasms

Conditions: Keywords:
Radiation Therapy
Patient reported outcomes
Remote monitoring
Mobile phone application

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Other
Intervention name: Remote monitoring PROs
Description: Attendance at RT review appointments triaged based on remotely monitored PROs
Arm group label: Remote monitoring PROs

Other name: Zamplo mobile healthcare application

Summary: 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.

Detailed description: Rationale: Remote monitoring of mPROs provides a platform for near real-time monitoring and action, resulting in the systematic reporting of symptoms and the potential for earlier healthcare interventions to treat those symptoms. The use of mPRO monitoring has been linked to improved survival and quality of life in patients receiving chemotherapy. It is likely therefore, that similar benefits will be seen in RT, particularly in the period immediately after RT has finished. In this study, the collection of mPROs will inform decision making when determining if a patient should be seen by a radiation oncologist. This will ensure patients in need of care are seen in a timely manner, if and when required. For a patient and caregiver, reduced time at the hospital leads to reduced opportunity costs (e.g. time) and out-of-pocket fees (e.g. parking). For the physician, the work time and clinic space gained from not seeing 'well' patients can be re-allocated to seeing 'unwell' patients or seeing new patient consultations to improve access to RT services. Hence, remotely monitoring mPROs to shape RT supportive care processes may reduce costs for patients and improve efficiency for physicians without a detrimental impact on quality of care. To date, no research has evaluated the use of remote monitored mPROs to triage RT patients' supportive care, based on patient assessments of need. It is hypothesized that the use of remote mPRO monitoring will reduce the number of in-person review visits during RT and/or improve patient care immediately after RT. Objectives: Primary) To determine if remote mPRO monitoring influences the proportion of review visits necessary during and up to 12 weeks after RT. Secondary) To determine the patient and treatment factors that influence the number and pattern of radiation HCP assessments needed during and up to 12 weeks after RT; to quantify the impact of mPRO remote monitoring on the frequency of adverse events and the use of unscheduled acute care services.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Clinical diagnosis of breast or prostate cancer - About to receive a course of radical or adjuvant radiation therapy as an outpatient at Princess Margaret Cancer Centre - Able to enter PRO responses into the mobile app in English or French Exclusion Criteria: - Significant comorbidities that would render the patient not suitable for remote monitoring

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Princess Margaret Cancer Centre

Address:
City: Toronto
Zip: M5G 2J9
Country: Canada

Status: Recruiting

Contact:
Last name: Tara Rosewall

Phone: 4162098269
Email: tara.rosewall@rmp.uhn.ca

Contact backup:
Last name: Winnie Li

Phone: 4169462000
Email: winnie.li@uhn.ca

Start date: April 9, 2024

Completion date: October 31, 2025

Lead sponsor:
Agency: University Health Network, Toronto
Agency class: Other

Source: University Health Network, Toronto

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06274892