Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-03 @ 9:27 PM
Study NCT ID:
NCT03343093
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2017-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Restore: Improving Sexual Outcomes of Gay and Bisexual Prostate Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D007172', 'term': 'Erectile Dysfunction'}], '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': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kilian@umn.edu', 'phone': '612-626-9568', 'title': 'Gudrun Kilian', 'organization': 'University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected for the entire 24-month trial period, beginning when the first participant accessed study materials until the last participant returned the 24-month survey.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Evaluation Control Group', 'description': 'Surveys at 3 month intervals\n\nControl: usual care, surveys every 3 months', 'otherNumAtRisk': 197, 'deathsNumAtRisk': 197, 'otherNumAffected': 0, 'seriousNumAtRisk': 197, 'deathsNumAffected': 4, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intervention Evaluation Test Group', 'description': 'We will evaluate the effects of an educational, tailored, online rehabilitation program addressing sexual and urinary outcomes after treatment by surveying at 3 month intervals\n\nRestore Rehabilitation Program: Multi-component, structured, biopsychosocial, online interactive program to address the sexual and urinary effects of prostate cancer treatment', 'otherNumAtRisk': 204, 'deathsNumAtRisk': 204, 'otherNumAffected': 0, 'seriousNumAtRisk': 204, 'deathsNumAffected': 4, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Urinary Function Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Evaluation Control Group', 'description': 'Surveys at 3 month intervals\n\nControl: usual care, surveys every 3 months'}, {'id': 'OG001', 'title': 'Intervention Evaluation Test Group', 'description': 'We will evaluate the effects of an educational, tailored, online rehabilitation program addressing sexual and urinary outcomes after treatment by surveying at 3 month intervals\n\nRestore Rehabilitation Program: Multi-component, structured, biopsychosocial, online interactive program to address the sexual and urinary effects of prostate cancer treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '80.1', 'groupId': 'OG000', 'lowerLimit': '78.1', 'upperLimit': '82.2'}, {'value': '81.4', 'groupId': 'OG001', 'lowerLimit': '79.4', 'upperLimit': '83.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'The Urinary Function domain of the Expanded Prostate Cancer Index Composite (EPIC-50) scale was used to assess the frequency of urinary symptoms. Scores range from 0 to 100, with higher scores indicating less frequency of urinary symptoms.', 'unitOfMeasure': 'Scores on a scale (0-100)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Sexual Functioning Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Evaluation Control Group', 'description': 'Surveys at 3 month intervals\n\nControl: usual care, surveys every 3 months'}, {'id': 'OG001', 'title': 'Intervention Evaluation Test Group', 'description': 'We will evaluate the effects of an educational, tailored, online rehabilitation program addressing sexual and urinary outcomes after treatment by surveying at 3 month intervals\n\nRestore Rehabilitation Program: Multi-component, structured, biopsychosocial, online interactive program to address the sexual and urinary effects of prostate cancer treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000', 'lowerLimit': '34.7', 'upperLimit': '40.3'}, {'value': '36.7', 'groupId': 'OG001', 'lowerLimit': '33.9', 'upperLimit': '39.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'The Sexual Functioning domain of the Expanded Prostate Cancer Index Composite (EPIC-50) scale was used to assess the frequency of sexual functioning symptoms. Scores range from 0 to 100, with higher scores indicating less frequency of sexual functioning symptoms.', 'unitOfMeasure': 'Scores on a scale (0-100)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Intervention Acceptability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Evaluation Test Group', 'description': 'Acceptability was measured by how much intervention group participants thought about the intervention content, would recommended the intervention to a friend, and liked the intervention being tailored to SGM as measured by 5-point Likert items. Satisfaction with the intervention content was measured by adapting EDITS.'}], 'classes': [{'categories': [{'measurements': [{'value': '156', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3-month follow-up', 'description': 'Acceptability was measured by how much intervention group participants would recommend the intervention to a friend (if he had prostate cancer). This single Likert-type item has five response options from 1=strongly agree to 5= strongly disagree. Acceptability will be measured by adding those who answered 1=strongly agree or 2=agree on this item.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Percent frequencies of those rating the intervention as acceptable'}, {'type': 'PRIMARY', 'title': 'Intervention Feasibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Evaluation Test Group', 'description': 'Feasibility was measured as the number of intervention participants who received the study aids and accessed the intervention website.'}], 'classes': [{'categories': [{'measurements': [{'value': '189', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3-month follow-up', 'description': 'Feasibility will be measured by monitoring the number of intervention participants who could access the intervention webpage at least once within the first three months of the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Percent participants who where able to access the intervention at least once.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Evaluation Control Group', 'description': 'Surveys at 3 month intervals\n\nControl: usual care, surveys every 3 months'}, {'id': 'FG001', 'title': 'Intervention Evaluation Test Group', 'description': 'We will evaluate the effects of an educational, tailored, online rehabilitation program addressing sexual and urinary outcomes after treatment by surveying at 3 month intervals\n\nRestore Rehabilitation Program: Multi-component, structured, biopsychosocial, online interactive program to address the sexual and urinary effects of prostate cancer treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '199'}, {'groupId': 'FG001', 'numSubjects': '204'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '180'}, {'groupId': 'FG001', 'numSubjects': '175'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '29'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'BG000'}, {'value': '204', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Evaluation Control Group', 'description': 'Surveys at 3 month intervals\n\nControl: usual care, surveys every 3 months'}, {'id': 'BG001', 'title': 'Intervention Evaluation Test Group', 'description': 'We will evaluate the effects of an educational, tailored, online rehabilitation program addressing sexual and urinary outcomes after treatment by surveying at 3 month intervals\n\nRestore Rehabilitation Program: Multi-component, structured, biopsychosocial, online interactive program to address the sexual and urinary effects of prostate cancer treatment'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.9', 'spread': '6.6', 'groupId': 'BG000'}, {'value': '64', 'spread': '6.7', 'groupId': 'BG001'}, {'value': '63.5', 'spread': '6.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '204', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '179', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '365', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-29', 'size': 377997, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-10-23T09:03', 'hasProtocol': True}, {'date': '2023-11-13', 'size': 202775, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-11-20T23:33', 'hasProtocol': False}, {'date': '2019-01-01', 'size': 276278, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-03-05T11:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 403}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-05', 'studyFirstSubmitDate': '2017-10-30', 'resultsFirstSubmitDate': '2023-10-23', 'studyFirstSubmitQcDate': '2017-11-10', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-05', 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary Function Scores', 'timeFrame': '24 months', 'description': 'The Urinary Function domain of the Expanded Prostate Cancer Index Composite (EPIC-50) scale was used to assess the frequency of urinary symptoms. Scores range from 0 to 100, with higher scores indicating less frequency of urinary symptoms.'}, {'measure': 'Sexual Functioning Scores', 'timeFrame': '24 months', 'description': 'The Sexual Functioning domain of the Expanded Prostate Cancer Index Composite (EPIC-50) scale was used to assess the frequency of sexual functioning symptoms. Scores range from 0 to 100, with higher scores indicating less frequency of sexual functioning symptoms.'}, {'measure': 'Intervention Acceptability', 'timeFrame': '3-month follow-up', 'description': 'Acceptability was measured by how much intervention group participants would recommend the intervention to a friend (if he had prostate cancer). This single Likert-type item has five response options from 1=strongly agree to 5= strongly disagree. Acceptability will be measured by adding those who answered 1=strongly agree or 2=agree on this item.'}, {'measure': 'Intervention Feasibility', 'timeFrame': '3-month follow-up', 'description': 'Feasibility will be measured by monitoring the number of intervention participants who could access the intervention webpage at least once within the first three months of the study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Erectile Dysfunction'], 'conditions': ['Prostatic Neoplasm']}, 'referencesModule': {'references': [{'pmid': '34348045', 'type': 'DERIVED', 'citation': 'Rosser BRS, Polter EJ, Chandiramani N, Cahill S, Wheldon CW, Konety BR, Ryan CJ, Haggart R, Kapoor A. Acceptability and Feasibility of Collecting Sexual Orientation and Expanded Gender Identity Data in Urology and Oncology Clinics. LGBT Health. 2021 Aug-Sep;8(6):420-426. doi: 10.1089/lgbt.2020.0256. Epub 2021 Aug 4.'}]}, 'descriptionModule': {'briefSummary': 'Development and evaluation of an online intervention addressing sexual functioning in gay and bisexual men (GBM) after prostate cancer treatment.', 'detailedDescription': "This study advances research in three areas.\n\nFirst, prostate cancer is the second most common cancer among gay, bisexual, and other men who have sex with men with documented disparities, yet it is severely under-researched. Because gay sex differs from vaginal sex, physiologically; the results from 614 studies focused on heterosexual men likely do not generalize to gay and bisexual men(GBM) with prostate cancer. There have been no rehabilitation studies specific to GBM survivors of prostate cancer, so clinicians have no relevant studies to inform best practice with their GBM patients.\n\nSecond, most prostate cancer studies have tested one or rehabilitation components. The investigators will conduct the first treatment study of a state of clinical practice comprehensive rehabilitation program on GBM's quality of life, including on both urinary and sexual function and bother measures.\n\nThird, almost all prostate cancer studies have focused on men recently treated for prostate cancer.\n\nThe long-term objective of this research is to improve the health of gay and bisexual survivors of Prostate cancer and to provide an evidence base for rehabilitation. The Investigators will develop an online rehabilitation program tailored for GBM that addresses both the sexual and urinary effects of prostate cancer treatment. In addition, The Investigators will conduct a comparative recruitment study to identify best methods to recruit 450 GBM with Prostate cancer.\n\nFinally, the Investigators will evaluate the effects of the tailored rehabilitation program on sexual and urinary outcomes. The Investigators will conduct a 24 month, randomized controlled trial of structured rehabilitation versus routine care. The Investigators will study both GBM recently treated (last 2 years) and GBM post-treatment (2+ years), using a stratified design. This randomized control trial will identify whether a structured rehabilitation program is effective in addressing the major sexual and urinary problems caused by Prostate cancer treatment. As the first treatment study to focus on GBM with Prostate cancer (and also on oral and anal sex), it addresses a long-standing health disparity.\n\nThe study has high potential to transform rehabilitation for GBM with Prostate cancer, provide a critical evidence base for clinicians, and inform rehabilitation outcomes for all Prostate cancer survivors."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Male bodied persons at risk of prostate cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Gay or Bisexual Men, defined as a biological adult male, who by self-report, has had sex with a man.\n2. Treated for prostate cancer, defined as (i) having been diagnosed with prostate cancer and measured by being able to report a Prostate- Specific Antigen and Gleason score; and (ii) treated by radical prostatectomy, radiation or systemically.\n3. Has recent problems with sexual and/or urinary function, by self-report. This is measured by a screener item(s) asking the enrollee to describe their current function (last 4 weeks) and validated by nurse interview.\n4. Internet-using\n5. Living in the US (including territories) as measured by valid US zip code\n6. A unique, validated individual, as measured by our published de-duplication and cross-validation protocols,230-232 and confirmed by video or phone interview.\n\nExclusion Criteria:\n\n1. No Nerve Sparing and Salvage therapy.\n2. Medical contraindications as determined by investigators at screening\n3. Heavy smoking: more than 10 cigarettes, cigars, e-cigarettes, snuff pipe or similar product on an average day (screened over last 7 days)\n4. Heavy alcohol use: more than 4 drinks per day, on two or more days, last 7 days\n5. Participation is limited to English speakers/readers since intervention materials and surveys are in English.\n6. Cognitive impairment.'}, 'identificationModule': {'nctId': 'NCT03343093', 'briefTitle': 'Restore: Improving Sexual Outcomes of Gay and Bisexual Prostate Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Restore: Improving Sexual Outcomes of Gay and Bisexual Prostate Cancer Survivors', 'orgStudyIdInfo': {'id': 'SPH-2018-26507'}, 'secondaryIdInfos': [{'id': '1R01CA218657-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01CA218657-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Evaluation Control Group', 'description': 'Surveys at 3 month intervals', 'interventionNames': ['Behavioral: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Evaluation Test Group', 'description': 'We will evaluate the effects of an educational, tailored, online rehabilitation program addressing sexual and urinary outcomes after treatment by surveying at 3 month intervals', 'interventionNames': ['Behavioral: Restore Rehabilitation Program']}], 'interventions': [{'name': 'Restore Rehabilitation Program', 'type': 'BEHAVIORAL', 'description': 'Multi-component, structured, biopsychosocial, online interactive program to address the sexual and urinary effects of prostate cancer treatment', 'armGroupLabels': ['Intervention Evaluation Test Group']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'usual care, surveys every 3 months', 'armGroupLabels': ['Intervention Evaluation Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55454', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Twin Cities Campus', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'B. Simon Rosser, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}