Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT03434535
Status:
COMPLETED
Last Update Posted:
2019-12-13
First Post:
2018-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pilot Study of Remote Monitoring to Improve Health Related Quality of Life of Men Following Prostate Cancer Treatment.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-11', 'studyFirstSubmitDate': '2018-02-06', 'studyFirstSubmitQcDate': '2018-02-13', 'lastUpdatePostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health-Related Quality of Life', 'timeFrame': 'Baseline', 'description': '36-Item Short Form (SF) Survey. This survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section and the scores range from 0-100. A score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability.'}, {'measure': 'Health-Related Quality of Life', 'timeFrame': '1 month after baseline', 'description': '36-Item Short Form Survey. This survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section and the scores range from 0-100. A score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability.'}, {'measure': 'Health-Related Quality of Life', 'timeFrame': '2 months after baseline', 'description': '36-Item Short Form Survey. This survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section and the scores range from 0-100. A score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability.'}, {'measure': 'Health-Related Quality of Life', 'timeFrame': '3 months after baseline', 'description': '36-Item Short Form Survey. This survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section and the scores range from 0-100. A score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Health-Related Quality Of Life']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the feasibility of using digital technology and remote monitoring to track health-related measures in men following prostate cancer treatment. Half of the participants will receive tools to monitor their activity and weight, as well as personalized feedback on these measures, while the other half will receive standard of care. Health related quality of life measure will be collected from both groups.', 'detailedDescription': "The purpose of this study is to determine the feasibility of using digital technology and remote monitoring to track health-related measures in men following prostate cancer treatment. All participants will complete a health-related quality of life survey each month for 3 months. The digital survey will be administered on a programmed tablet. The participants in the intervention group will also receive an activity sensor and weight scale. Health state data from this group will be generated over a 3-6 month period and remotely monitored. These data will be used to provide personalized feedback regarding the participant's progress towards established goals. Health-related quality of life will be compared between participants in the intervention group, who receive (1) tools to monitor their activity and weight and (2) personalized feedback, versus participants in the control group, who receive standard of care. The potential improved adherence to healthy behaviors of the participants receiving personalized feedback may translate to to improved health-related quality of life."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must have localized prostate cancer.\n* Participants must have received treatment at Johns Hopkins\n* Participants must be classified as overweight (body mass index ≥ 25).\n* Participants must have wi-fi in their homes.\n\nExclusion Criteria:\n\n* Anyone who is unable to give informed consent will be excluded\n* Anyone who is physically unable to participate in physical activity will be excluded.'}, 'identificationModule': {'nctId': 'NCT03434535', 'briefTitle': 'A Pilot Study of Remote Monitoring to Improve Health Related Quality of Life of Men Following Prostate Cancer Treatment.', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'A Pilot Study of Remote Monitoring to Improve Health Related Quality of Life of Men Following Prostate Cancer Treatment.', 'orgStudyIdInfo': {'id': 'IRB00156374'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': "The participants will complete a digital health-related quality of life survey on a programmed tablet at baseline and each month for the following 3-6 months. They will also receive an activity sensor and weight scale. Health state data from this group will be generated over a 3-6 month period and remotely monitored. These data will be used to provide personalized feedback regarding the participant's progress towards established goals.", 'interventionNames': ['Device: Technology Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The participants will complete a digital health-related quality of life survey on a programmed tablet at baseline and each month for the following 3-6 months.'}], 'interventions': [{'name': 'Technology Intervention', 'type': 'DEVICE', 'otherNames': ['Fitbit Alta HR', 'Fitbit Aria'], 'description': "A combination of existing technology and a new app developed by InHealth Measurement Corp to (1) remotely monitor a participant's activity level and weight and (2) remotely provide updates to the participants regarding their progress towards the goals established in the Prostate Cancer Foundation Health and Wellness guidelines.", 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Peter Searson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}