Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2J9, Canada
Location status: Recruiting
NCT Number: NCT06274892
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Toronto, Ontario, M5G 2J9, Canada
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Attendance at RT review appointments triaged based on remotely monitored PROs
Other names: Zamplo mobile healthcare application
Time frame: At the end of radiation (average 5 weeks), and 12 weeks after completion of radiation
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.
Time frame: At the end of radiation (average 5 weeks), and 12 weeks after completion of radiation
Frequency of Grade 2 or above toxicity (PRO-CTCAE v1) (from mPRO entries)
Time frame: At the end of radiation (average 5 weeks)
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.
Time frame: At the end of radiation (average 5 weeks), and 12 weeks after completion of radiation
Number of times unscheduled acute care services were used (from questionnaire)
Time frame: At the end of radiation (average 5 weeks)
Sociodemographic factors (from questionnaire) associated with the proportion of review visits attended
Time frame: At the end of radiation (average 5 weeks)
Disease factors (from chart review) associated with the proportion of review visits attended
Time frame: At the end of radiation (average 5 weeks)
Treatment factors (from chart review) associated with the proportion of review visits attended
Time frame: 12 weeks after completion of radiation
Frequency of Grade 2 or above toxicity (PRO-CTCAE v1) 'during RT' associated with the proportion of 'after RT' review visits
Contact information is provided by the study sponsor or research team.
University Health Network, Toronto
Other
Acronym: PROMOTE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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