Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-03-05 @ 4:34 AM
Study NCT ID:
NCT01716702
Status:
COMPLETED
Last Update Posted:
2024-08-21
First Post:
2012-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Feasibility Study of an Online Intervention for Sexual Rehabilitation in Prostate Cancer
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': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2016-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2012-10-16', 'studyFirstSubmitQcDate': '2012-10-26', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Profile of Mood States Short Form from baseline to 13 weeks', 'timeFrame': 'Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)', 'description': 'This tool assesses psychological distress across 6 domains: fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment.'}], 'primaryOutcomes': [{'measure': 'Change in Sexual Function from Baseline to 13 weeks', 'timeFrame': 'Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)'}], 'secondaryOutcomes': [{'measure': 'Change in Personal Assessment of Intimacy and Relationships from baseline to 13 weeks', 'timeFrame': 'Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prostate Cancer', 'Psychosocial Intervention', 'Sexual Rehabilitation', 'Online Intervention'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Background: Prostate cancer (PCa) is the most common cancer for men. When treated early enough it is typically curable. However, common treatments, such as radical prostatectomy and radiation therapy, often result in significant negative outcomes with regard to sexual, psychological and social function. Both men and partners have identified the need for more information and support to address sexual health concerns after treatment. However, very few sexual rehabilitation interventions have been developed and rigorously assessed.\n\nPurpose: The investigators propose to develop and pilot test a new program to meet the sexual health needs of men with PCa and their partners using an online, professionally facilitated education/support program. The goals of the program are to improve sexual function, intimacy and mood for men and their partners after treatment for localized PCa. The program will be offered through Cancer Chat Canada, an existing and well-tested Canadian platform for professionally facilitated support group programs.\n\nWhat Participants Can Expect: A total of 24 men and their female partners (48 individuals) will be recruited and assigned to one of two groups. The first group will participate in the program immediately; the second group will be offered the program after a 5-month delay. The decision about which group will start immediately and which later will be made randomly (by chance). Both groups of men and partners will be asked to complete questionnaires three times and, at the end of the program, to provide the researchers feedback about how satisfied they were with the program, the changes they made, things they learned as a result of the program, and suggestions for improving the program. Participants must have access to a computer, an Internet connection and be willing to attend online, chat room meetings each week for 1.5 hours for 6 weeks.\n\nImplications: Sexual rehabilitation is a high need for men affected by PCa, but is difficult to access. The investigators hope to improve access to sexual health care through this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men who have been treated for localized prostate cancer\n* AND men must be 6-36 months post-prostatectomy or radiation (as primary treatment) of prostate cancer\n* Must have a heterosexual, co-cohabiting partner who is willing to participate\n* Must speak and read English\n* Must be able to use a computer and have internet access\n\nExclusion Criteria:\n\n* Homosexual couples will not be included in this study\n* Major self-reported psychiatric illness\n* Couples who screen below 30 on the DAS (Dyadic Adjustment Scale)'}, 'identificationModule': {'nctId': 'NCT01716702', 'briefTitle': 'A Feasibility Study of an Online Intervention for Sexual Rehabilitation in Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Nova Scotia Health Authority'}, 'officialTitle': 'A Feasibility Study of an Online Intervention for Sexual Rehabilitation in Prostate Cancer', 'orgStudyIdInfo': {'id': 'CDHA-RS/2013-076'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Couples Prostate Cancer Support Group', 'description': 'The participants in the support group will receive 6 weekly online intervention sessions with a professional facilitator. In addition participants will be asked to complete relationship-enhancement exercises and readings in between sessions.\n\nParticipants will be asked to complete questionnaires at three time points: 1)pre-intervention (baseline) 2) post-intervention (7 weeks), and 3) post intervention (13 weeks).', 'interventionNames': ['Behavioral: Couples Prostate Cancer Support Group']}, {'type': 'NO_INTERVENTION', 'label': 'Wait-List Control', 'description': 'Participants will be asked to complete questionnaires at three time points: 1)week 1 2) week 7, and 3) week 13.'}], 'interventions': [{'name': 'Couples Prostate Cancer Support Group', 'type': 'BEHAVIORAL', 'description': 'The participants in the experimental group will receive 6 weekly online intervention sessions with a professional facilitator. In addition participants will be asked to complete relationship-enhancement exercises and readings in between sessions.\n\nIn the experimental group, participants will be asked to complete questionnaires at three time points: 1)pre-intervention (baseline) 2) post-intervention (7 weeks), and 3) post intervention (13 weeks).\n\nIn the waitlist group, participants will not participate in the support group. Participants will be asked to complete questionnaires at three time points: 1)pre-intervention (baseline) 2) post-intervention (7 weeks), and 3) post intervention (13 weeks).', 'armGroupLabels': ['Couples Prostate Cancer Support Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Capital District', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}], 'overallOfficials': [{'name': 'Deborah L McLeod, R.N., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Capital District Health Authority & Dalhousie University'}, {'name': 'Richard J Wassersug, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}, {'name': 'Karen Fergus, Ph.D., C. Psych.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Odette Cancer Centre & York University'}, {'name': 'John Robinson, Ph.D., C. Psych.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tom Baker Cancer Centre & University of Calgary'}, {'name': 'John Oliffe, R.N, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nova Scotia Health Authority', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}