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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Prostate Cancer
• Intervention / Treatment: Other: Remote monitoring PROs

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.

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tara Rosewall, PhD; Phone Number: 416 946 2000; Email: tara.rosewall@rmp.uhn

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2J9
      • Recruiting
      • Princess Margaret Cancer Centre
      • Contact: Tara Rosewall; Phone Number: 4162098269; Email: tara.rosewall@rmp.uhn.ca
      • Contact: Winnie Li; Phone Number: 4169462000; Email: winnie.li@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remote monitoring PROs; 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.	Other: Remote monitoring PROs; Attendance at RT review appointments triaged based on remotely monitored PROs; Other Names: Zamplo mobile healthcare application
No Intervention: Standard of Care; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remote monitoring efficiency	Proportion of review visits attended during RT, and up to 12 weeks after RT. Number of review visits attended (from weekly participant questionnaire) as a percentage of the total possible review visits. Values will range from 0% to 100%. Low percentage indicates desirable outcome.	At the end of radiation (average 5 weeks), and 12 weeks after completion of radiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remote monitoring efficacy	Frequency of Grade 2 or above toxicity (PRO-CTCAE v1) (from mPRO entries)	At the end of radiation (average 5 weeks), and 12 weeks after completion of radiation
Remote monitoring value	Patient assessment of review 'value' (from weekly participant questionnaire) for each review visit attended. Question asked "Was the review session a valuable use of your time?". Response options: 4 point Likert scale "Not at all, A little bit, Quite a bit, Very much". Values will range from 0 to 3. High score indicates desirable outcome.	At the end of radiation (average 5 weeks)
Remote monitoring comprehensiveness	Number of times unscheduled acute care services were used (from questionnaire)	At the end of radiation (average 5 weeks), and 12 weeks after completion of radiation
Influencing factors (patient)	Sociodemographic factors (from questionnaire) associated with the proportion of review visits attended	At the end of radiation (average 5 weeks)
Influencing factors (disease)	Disease factors (from chart review) associated with the proportion of review visits attended	At the end of radiation (average 5 weeks)
Influencing factors (treatment)	Treatment factors (from chart review) associated with the proportion of review visits attended	At the end of radiation (average 5 weeks)
Influencing factors (toxicity)	Frequency of Grade 2 or above toxicity (PRO-CTCAE v1) 'during RT' associated with the proportion of 'after RT' review visits	12 weeks after completion of radiation

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2024
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Patient reported outcomes; Radiation Therapy; Remote monitoring; Mobile phone application
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 23-5818

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No