Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-29 @ 7:51 AM
Study NCT ID:
NCT06274892
Status:
RECRUITING
Last Update Posted:
2024-10-17
First Post:
2023-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remote Monitoring of Patient Reported Outcomes to Improve the Efficacy of the Acute Phase Radiotherapy Review Process
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-15', 'studyFirstSubmitDate': '2023-10-25', 'studyFirstSubmitQcDate': '2024-02-15', 'lastUpdatePostDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remote monitoring efficiency', 'timeFrame': 'At the end of radiation (average 5 weeks), and 12 weeks after completion of radiation', 'description': '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.\n\nValues will range from 0% to 100%. Low percentage indicates desirable outcome.'}], 'secondaryOutcomes': [{'measure': 'Remote monitoring efficacy', 'timeFrame': 'At the end of radiation (average 5 weeks), and 12 weeks after completion of radiation', 'description': 'Frequency of Grade 2 or above toxicity (PRO-CTCAE v1) (from mPRO entries)'}, {'measure': 'Remote monitoring value', 'timeFrame': 'At the end of radiation (average 5 weeks)', 'description': 'Patient assessment of review \'value\' (from weekly participant questionnaire) for each review visit attended.\n\nQuestion 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".\n\nValues will range from 0 to 3. High score indicates desirable outcome.'}, {'measure': 'Remote monitoring comprehensiveness', 'timeFrame': 'At the end of radiation (average 5 weeks), and 12 weeks after completion of radiation', 'description': 'Number of times unscheduled acute care services were used (from questionnaire)'}, {'measure': 'Influencing factors (patient)', 'timeFrame': 'At the end of radiation (average 5 weeks)', 'description': 'Sociodemographic factors (from questionnaire) associated with the proportion of review visits attended'}, {'measure': 'Influencing factors (disease)', 'timeFrame': 'At the end of radiation (average 5 weeks)', 'description': 'Disease factors (from chart review) associated with the proportion of review visits attended'}, {'measure': 'Influencing factors (treatment)', 'timeFrame': 'At the end of radiation (average 5 weeks)', 'description': 'Treatment factors (from chart review) associated with the proportion of review visits attended'}, {'measure': 'Influencing factors (toxicity)', 'timeFrame': '12 weeks after completion of radiation', 'description': "Frequency of Grade 2 or above toxicity (PRO-CTCAE v1) 'during RT' associated with the proportion of 'after RT' review visits"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Radiation Therapy', 'Patient reported outcomes', 'Remote monitoring', 'Mobile phone application'], 'conditions': ['Prostate Cancer', 'Breast Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nPatients 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.\n\nCurrently, 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.\n\nUsing 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.', 'detailedDescription': "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.\n\nIn 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.\n\nTo 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.\n\nObjectives: 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of breast or prostate cancer\n* About to receive a course of radical or adjuvant radiation therapy as an outpatient at Princess Margaret Cancer Centre\n* Able to enter PRO responses into the mobile app in English or French\n\nExclusion Criteria:\n\n* Significant comorbidities that would render the patient not suitable for remote monitoring'}, 'identificationModule': {'nctId': 'NCT06274892', 'acronym': 'PROMOTE', 'briefTitle': 'Remote Monitoring of Patient Reported Outcomes to Improve the Efficacy of the Acute Phase Radiotherapy Review Process', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Remote Monitoring of Patient Reported Outcomes to Improve the Efficacy of the Acute Phase Radiotherapy Review Process', 'orgStudyIdInfo': {'id': '23-5818'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remote monitoring PROs', 'description': "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.", 'interventionNames': ['Other: Remote monitoring PROs']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': "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)."}], 'interventions': [{'name': 'Remote monitoring PROs', 'type': 'OTHER', 'otherNames': ['Zamplo mobile healthcare application'], 'description': 'Attendance at RT review appointments triaged based on remotely monitored PROs', 'armGroupLabels': ['Remote monitoring PROs']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2J9', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Tara Rosewall', 'role': 'CONTACT', 'email': 'tara.rosewall@rmp.uhn.ca', 'phone': '4162098269'}, {'name': 'Winnie Li', 'role': 'CONTACT', 'email': 'winnie.li@uhn.ca', 'phone': '4169462000'}], 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Tara Rosewall, PhD', 'role': 'CONTACT', 'email': 'tara.rosewall@rmp.uhn', 'phone': '416 946 2000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}