Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-25 @ 4:10 PM
Study NCT ID:
NCT04193657
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2019-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Toward a Comprehensive Supportive Care Intervention for Older or Frail Men With mCRPC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D000073496', 'term': 'Frailty'}], '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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-17', 'studyFirstSubmitDate': '2019-12-05', 'studyFirstSubmitQcDate': '2019-12-06', 'lastUpdatePostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daily monitoring with Edmonton Symptom Assessment Scale (ESAS)', 'timeFrame': '3-4 weeks', 'description': 'Number of participants with treatment-related adverse events as measured by ESAS.Moderate or higher symptoms (\\>3/10) on ESAS triggers more detailed telephone-based toxicity assessment'}, {'measure': 'Using a personal physical activity tracker step counts are monitored daily.', 'timeFrame': '3-4 weeks', 'description': 'Number of participants with a decrease in daily step count of 15% or more that triggers more detailed telephone-based assessment.'}, {'measure': 'Brief Pain Inventory-Short Form (BPI-SF) to measure pain severity', 'timeFrame': '3-4 weeks', 'description': 'Number of participants with ESAS pain score greater than 3 that triggered BPI-SF. than 3'}, {'measure': 'Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) to measure fatigue', 'timeFrame': '3-4 weeks', 'description': 'Number of participants with ESAS fatigue score greater than 3 that triggered MFSI-SF.'}, {'measure': 'Insomnia Severity Index (ISI) to measure treatment related insomnia', 'timeFrame': '3-4 weeks', 'description': 'Number of participants with ESAS insomnia score greater than 3 that triggered ISI'}, {'measure': 'Patient Health Questionnaire 9-item (PHQ-9) to measure treatment related depression', 'timeFrame': '3-4 weeks', 'description': 'Number of participants with ESAS depression score greater than 3 that triggered PHQ-9.'}, {'measure': 'Generalized Anxiety Disorder 7-item (GAD) to measure treatment related anxiety', 'timeFrame': '3-4 weeks', 'description': 'Number of participants with ESAS anxiety score greater than 3 that triggered GAD'}], 'secondaryOutcomes': [{'measure': 'Participants symptom experience by Qualitative interview', 'timeFrame': '30 minutes', 'description': 'Participants in each treatment arm will be invited to participate in semi-structured one-time qualitative interviews after one cycle of treatment. The interview will focus on the symptom experience, impact on daily life, strategies used to manage symptoms, and suggestions for external support.'}, {'measure': 'Study Completion Questionnaire to measure participant burden and satisfaction', 'timeFrame': '5 minutes', 'description': 'Number of participants that experienced burden or satisfaction by the study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metastatic Prostate Cancer', 'Older men', 'Supportive care', 'Frailty'], 'conditions': ['Metastatic Prostate Cancer']}, 'descriptionModule': {'briefSummary': '1. Multicentre pilot study (n=90) which aims to study a prevalent population of elderly or frail patients with mCRPC whom are often excluded from clinical trial participation. (Data is sorely needed in this population)\n2. The study aims to determine:\n\n 1. if symptom monitoring (daily) is feasible using telephone or electronic means of communications in the elderly or frail patient with mCRPC\n 2. The time course/pattern of symptoms important to quality of life for patients undergoing chemotherapy, abi/enza, or Radium 223\n 3. If changes in physical activity (quantified by fitbit) predict for changes to ESAS in men undergoing treatment d) Qualitatively assess the supportive care needs of older/frail men with mCRPC', 'detailedDescription': 'Study Aim:\n\nThe previous multi-centre observational study (TOPCOP), funded by Prostate Cancer Canada, demonstrated important declines in multiple areas of quality of life, and fatigue and functional decline which were common issues that often limited further treatment. Emerging data from other settings demonstrate that (a) close monitoring of symptoms may reduce treatment toxicity and improve survival; (b) improving physical activity and targeting pain and sleep may improve fatigue and function. Whether these are feasible in the setting of older or frail men with mCRPC is unclear. Incorporating what the investigators have learned from TOPCOP and emerging supportive oncology literature, our main aim is to examine the emergence of key symptoms (fatigue, pain, insomnia) and explore whether reductions in daily physical activity are early indicators of toxicity over one treatment cycle (3-4 weeks) and therefore targetable in a subsequent intervention study.\n\nStudy Design:\n\nThis is a prospective multicentre observational study. The investigators will enroll English-speaking men with mCRPC who are either age 75 or older or age 60-74 and frail using (a) chemotherapy; (b) abiraterone or enzalutamide; (c) Radium.\n\nDaily telephone-based brief symptom screening will be done with the Edmonton Symptom Assessment Scale (ESAS). Daily monitoring of physical activity (step counts) will be done with commercial smartphone apps or a Fitbit device. Moderate or higher symptoms (\\>3/10) on ESAS or a decrease in daily step count of 15% or more triggers more detailed telephone-based toxicity assessment and measures of pain, sleep, and fatigue as appropriate. The study duration is 3 weeks (1 cycle of chemotherapy) or 4 weeks (abiraterone/enzalutamide/radium). Qualitative interviews will be done to explore challenges with treatment tolerability and adherence.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '1. Unable to speak English fluently.\n2. Severe neuropsychiatric abnormalities.\n3. Limited life expectancy (\\<3 months) as estimated by the primary oncologist or seeing palliative care.', 'genderDescription': 'Prostate cancer occurs in males only.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Starting either chemotherapy, Radium-223, Abiraterone or Enzalutamide or starting chemo \\> one year post CHAARTED\n2. At least 65 years old\n3. Able to provide written informed consent\n4. Diagnosed with metastatic castrate resistant prostate cancer\n5. Total Testosterone level 1.7nmol/L\n6. Has a working smartphone OR is willing to use a study provided smartphone\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04193657', 'acronym': 'TOPCOP2', 'briefTitle': 'Toward a Comprehensive Supportive Care Intervention for Older or Frail Men With mCRPC', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Toward a Comprehensive Supportive Care Intervention for Older or Frail Men With mCRPC', 'orgStudyIdInfo': {'id': '19-5766'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chemotherapy', 'description': '30 participants starting chemotherapy', 'interventionNames': ['Other: Daily and weekly triggered symptom monitoring']}, {'label': 'Abiraterone', 'description': '20 participants starting Abiraterone', 'interventionNames': ['Other: Daily and weekly triggered symptom monitoring']}, {'label': 'Enzalutamide', 'description': '20 participants starting Enzalutamide', 'interventionNames': ['Other: Daily and weekly triggered symptom monitoring']}, {'label': 'Radium-223', 'description': '20 participants starting Radium-223', 'interventionNames': ['Other: Daily and weekly triggered symptom monitoring']}], 'interventions': [{'name': 'Daily and weekly triggered symptom monitoring', 'type': 'OTHER', 'otherNames': ['Daily Step count'], 'description': 'Participants are invited to complete a daily questionnaire, a weekly questionnaire, and to track daily activity with an electronic activity tracker.', 'armGroupLabels': ['Abiraterone', 'Chemotherapy', 'Enzalutamide', 'Radium-223']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Odette Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Shabbir Alibhai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Prostate Cancer Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}