Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2026-02-28 @ 11:21 AM
Study NCT ID:
NCT02529150
Status:
COMPLETED
Last Update Posted:
2020-04-16
First Post:
2015-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
WISER After Ovarian Cancer - Exercise Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2016-05-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-15', 'studyFirstSubmitDate': '2015-06-19', 'studyFirstSubmitQcDate': '2015-08-19', 'lastUpdatePostDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of adverse events', 'timeFrame': '26 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'One in four deaths in the United States is due to cancer, and one in three women will develop cancer in her lifetime. Despite improvements in survival among other forms of cancer, ovarian cancer prognosis remains poor. Eighty percent of women with ovarian cancer will present with advanced disease (stage 3 or 4) where 5-year survival ranges from 18-34%.2 Among patients with stage III and IV epithelial ovarian cancer (EOC), recurrence rates are high.4 Therefore, interventions focused on preventing recurrence or slowing progression of EOC is a critical problem in the field. The investigators have submitted an R21 to NCI for a dose response exercise intervention trial to examine the dose response effects of aerobic exercise on biomarkers relevant to ovarian cancer progression and recurrence. The reviewers would like assurance that the investigators can recruit ovarian cancer patients into an exercise study and that these women will do the exercise protocol we plan to prescribe in our high dose of exercise.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of stage III-IV EOC, completed surgery,\n* \\> 12 months life expectancy (physician estimate),\n* able to walk 15 minutes at a time (use of a cane is acceptable).\n\nExclusion Criteria:\n\n* medical or psychiatric conditions (beyond ovarian cancer, its treatment, and its symptoms) that would impair our ability to test study hypotheses (e.g. cardiac, pulmonary, or\n* orthopedic history that would prohibit a program of walking for exercise;\n* psychotic disorders,\n* dementia,\n* inability to give informed consent'}, 'identificationModule': {'nctId': 'NCT02529150', 'briefTitle': 'WISER After Ovarian Cancer - Exercise Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'WISER After Ovarian Cancer - Exercise Pilot Study', 'orgStudyIdInfo': {'id': 'UPCC 38814'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'exercise', 'interventionNames': ['Behavioral: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'This is an exercise intervention study. All 10 participants will complete 26 weeks high dose exercise (60% of peak aerobic capacity 45 min/session, 5 sessions per week).', 'armGroupLabels': ['exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abramson Cancer Center of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Kathryn Schmitz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abramson Cancer Center at Penn Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}