Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-03-01 @ 6:28 AM
Study NCT ID:
NCT03331458
Status:
COMPLETED
Last Update Posted:
2019-08-26
First Post:
2017-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Activity in Men Newly Diagnosed With Prostate Cancer: A Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-22', 'studyFirstSubmitDate': '2017-11-01', 'studyFirstSubmitQcDate': '2017-11-01', 'lastUpdatePostDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in 6 minute walk test', 'timeFrame': 'baseline, 2 weeks post intervention', 'description': 'Distance walked in 6 minutes'}, {'measure': 'Change in balance test', 'timeFrame': 'baseline, 2 weeks post intervention', 'description': 'Ability to balance'}, {'measure': 'Change in time up to go test', 'timeFrame': 'baseline, 2 weeks post intervention', 'description': 'Time to get up from chair, walk 30 meters and return to sit in chair'}, {'measure': 'Change in Godin Leisure Time Score', 'timeFrame': 'baseline, 2 weeks post intervention', 'description': 'physical activity score'}, {'measure': 'Change in rate of perceived exertion', 'timeFrame': 'baseline, 2 weeks post intervention', 'description': 'physical exertion score'}, {'measure': 'Change in metabolic equivalent', 'timeFrame': 'baseline, 2 weeks post intervention', 'description': 'metabolic activity score'}, {'measure': 'Change in distress score', 'timeFrame': 'baseline, 2 weeks post intervention', 'description': 'distress score'}, {'measure': 'Change in self-efficacy score', 'timeFrame': 'baseline, 2 weeks post intervention', 'description': 'self-efficacy score'}, {'measure': 'Change in symptom inventory score', 'timeFrame': 'baseline, 2 weeks post intervention', 'description': 'description of symptoms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['physical activity'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Recent research has indicated that physical activities incorporating moderate-intensity exercise can be safely performed during treatment and substantially reduces treatment-related side effects, such as fatigue, sleep disturbances, cognitive impairment, and nausea. However, little is known about physical activity levels prior to treatment and whether providing an exercise intervention pre-treatment may improve functional capacity during treatment.\n\nThe purpose of this study is to\n\n1. Measure physical activity levels and functional capacity in men newly diagnosed with prostate cancer prior to treatment and\n2. Explore whether a 2-week physical activity intervention is feasible during the pre-treatment timeframe:\n\n 1. Examine intervention safety and tolerance by self-report\n 2. Examine changes in functional capacity by 6-minute walk test\n 3. Examine changes in symptom experience by self-report'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed with prostate cancer\n* will not start treatment for at least 2 weeks\n* able to read and understand English\n* capable of giving informed consent\n* at least 18 years old\n\nExclusion Criteria:\n\n* patients who are incompetent for interview (documented diagnosis of active psychosis or dementia)\n* unable to provide informed consent as assessed by the interviewer\n* too sick to participate, as judged by a member of the research team or the exercise physiologist\n* have been treated for another cancer'}, 'identificationModule': {'nctId': 'NCT03331458', 'acronym': 'PACMen', 'briefTitle': 'Physical Activity in Men Newly Diagnosed With Prostate Cancer: A Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Physical Activity in Men Newly Diagnosed With Prostate Cancer: A Feasibility Study', 'orgStudyIdInfo': {'id': 'Pro00083320'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'subjects with prostate cancer', 'interventionNames': ['Behavioral: exrecise intervention']}], 'interventions': [{'name': 'exrecise intervention', 'type': 'BEHAVIORAL', 'description': 'Subjects will undergo pre-intervention measures, complete a daily physical activity diary, and post-intervention measures', 'armGroupLabels': ['subjects with prostate cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27606', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Raleigh Cancer Center', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}], 'overallOfficials': [{'name': 'Deborah Allen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share feasibility study data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}