Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 12:33 AM
Study NCT ID:
NCT03761160
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2018-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mobile Health App to Mitigate the Metabolic Effects of Androgen Deprivation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-17', 'studyFirstSubmitDate': '2018-11-03', 'studyFirstSubmitQcDate': '2018-11-29', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accumulation of body fat mass', 'timeFrame': '2 years', 'description': 'This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.'}], 'secondaryOutcomes': [{'measure': 'Whole-body lean mass', 'timeFrame': '2 years', 'description': 'This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.'}, {'measure': 'Regional lean mass', 'timeFrame': '2 years', 'description': 'This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.'}, {'measure': 'Percent fat', 'timeFrame': '2 years', 'description': 'This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.'}, {'measure': 'Estimated visceral adipose', 'timeFrame': '2 years', 'description': 'This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.'}, {'measure': "Application's performance on iOS and Android platforms", 'timeFrame': '2 years', 'description': 'This outcome (for phase 1 of the trial) will be collected in 10 participants through verbal responses and/or computer either by the research coordinator or the participant. All data collected will be anonymously recorded.'}, {'measure': "Application's ability to effectively motivate and track outcomes for patients", 'timeFrame': '2 years', 'description': 'This outcome (for phase 1 of the trial) will be collected in 10 participants through verbal responses and/or computer either by the research coordinator or the participant. All data collected will be anonymously recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostate Cancer'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This research study seeks to develop and evaluate a mobile health app which aims to provide patients who are about to initiate androgen deprivation therapy for prostate cancer with an exercise program and better eating habits.', 'detailedDescription': 'This research study seeks to develop and evaluate a mobile health app which aims to provide patients who are about to initiate androgen deprivation therapy for prostate cancer with an exercise program and better eating habits. The first phase of the research study seeks to evaluate the experience of the first version of the mobile health app within a group of participants and what they think of it.\n\nThe investigators are interested in how individuals react to the use of a developed mobile health app and what they think of it.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPhase 1\n\n* All recruited participants must have owned a smartphone for \\>1 year\n* English-speaking.\n* Patients with prostate cancer aged between 40-75 years will be considered.\n* No specific timeframe after prostate cancer diagnosis will be required for these patients.\n* No limitations regarding their disease characteristics will be imposed (e.g. metastatic disease).\n* Patients may or may not be currently receiving treatment Staff members will be recruited from\n* Dana-Farber Cancer Institute Department of Medical Oncology,\n* Brigham and Women's Hospital, Department of Surgery. Staff members aged between 40-75 years old will be considered. Phase 2\n* Men diagnosed with prostate cancer presenting to DF/BWHCC\n* About to initiate ADT for the first time will be considered.\n* Age range 40-75-years\n* The ability to walk 400 m\n* Medical clearance from their primary physician\n* English speaking\n* Cognitively alert\n* Literate\n* Ability to read or hear with or without contacts/glass and hearing aid\n* Ownership of a smartphone for \\>1yr\n\nExclusion Criteria:\n\n* Men who have been under a rigorous structured exercise regime, such as individuals who engage in more than 900 minutes of moderate physical activity per week in the last 6 months will not be considered\n* Post-ADT treatment\n* Planned systemic chemotherapy\n* Planned treatment with abiraterone or enzalutamide\n* Bone metastases\n* Acute illness\n* Any musculoskeletal, cardiovascular, or neurologic disorders that could inhibit or put them at risk from exercising\n* Subordinates to the PI"}, 'identificationModule': {'nctId': 'NCT03761160', 'briefTitle': 'Mobile Health App to Mitigate the Metabolic Effects of Androgen Deprivation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'Mobile Health App to Mitigate the Metabolic Effects of Androgen Deprivation Therapy: A Randomize Pilot Trial in Men Newly Treated With Androgen Deprivation Therapy', 'orgStudyIdInfo': {'id': '17-692'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mobile Health App', 'description': "The developed mobile health app will include the following facets:\n\n* Physical activities\n* Dietary regimen.\n* The physical activities facet will encourage patients to engage in physical activities, with daily prompts, encouragement, and tips.\n* Users will be asked to record the type of physical activity they engaged in during the week, and for how long.\n* The dietary aspect will ask patients to log what they ate during the day and to rate how 'healthy' it is", 'interventionNames': ['Other: Mobile Health App']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': 'Usual care per hospital guideline', 'interventionNames': ['Other: Usual care']}], 'interventions': [{'name': 'Mobile Health App', 'type': 'OTHER', 'description': 'mobile health app aims to provide patients who are about to initiate androgen deprivation therapy for prostate cancer with an exercise program and better eating habit', 'armGroupLabels': ['Mobile Health App']}, {'name': 'Usual care', 'type': 'OTHER', 'description': 'Usual care per hospital guidelines', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'QUOC-DIEN TRINH, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data can be shared no earlier than 1 year following the date of publication.', 'ipdSharing': 'YES', 'description': 'The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \\[contact information for Sponsor- Investigator or designee\\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research', 'accessCriteria': 'Requests may be directed to: \\[contact information for Sponsor- Investigator or designee\\].'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Prostate Cancer Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Quoc-Dien Trinh, MD', 'investigatorAffiliation': 'Dana-Farber Cancer Institute'}}}}