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

Breast Cancer Clinical Trial

— PROMOTE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06274892
• Other study ID #: 23-5818
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: November 30, 2024

Study information

• Verified date: April 2024
• Source: University Health Network, Toronto
• Contact: Tara Rosewall, PhD
• Phone: 416 946 2000
• Email: tara.rosewall[@]rmp.uhn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: November 30, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Remote monitoring PROs
Attendance at RT review appointments triaged based on remotely monitored PROs

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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
Secondary	Influencing factors (patient)	Sociodemographic factors (from questionnaire) associated with the proportion of review visits attended	At the end of radiation (average 5 weeks)
Secondary	Influencing factors (disease)	Disease factors (from chart review) associated with the proportion of review visits attended	At the end of radiation (average 5 weeks)
Secondary	Influencing factors (treatment)	Treatment factors (from chart review) associated with the proportion of review visits attended	At the end of radiation (average 5 weeks)
Secondary	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