Ignite Creation Date:
2025-12-24 @ 11:59 PM
Ignite Modification Date:
2026-02-23 @ 1:11 AM
Study NCT ID:
NCT01982058
Status:
COMPLETED
Last Update Posted:
2022-10-19
First Post:
2013-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D019529', 'term': 'Sexuality'}], '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': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}, {'id': 'D004035', 'term': 'Diet Therapy'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 483}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-17', 'studyFirstSubmitDate': '2013-06-24', 'studyFirstSubmitQcDate': '2013-11-05', 'lastUpdatePostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychological Functioning', 'timeFrame': '5 years', 'description': 'General psychological functioning is assessed by the MHI-38 and the PHQ-9. Cancer-Specific distress is assessed by using the Impact of Events Scale Revised Cancer-Specific concerns is assessed with a 10 item assessment of commonly-experienced problems.'}, {'measure': 'Relationship Functioning', 'timeFrame': '5 years', 'description': 'Relationship satisfaction is assessed using the Dyadic Adjustment Scale'}], 'secondaryOutcomes': [{'measure': 'Intimacy', 'timeFrame': '5 years', 'description': 'General Relationship Intimacy. The Personal Assessment of Intimacy in Relationships Intimacy scale (PAIR) (94) is a 6 item scale assessing emotional closeness. Cancer-specific Relationship Intimacy (95-96) Participants rate the degree to which they felt close to and emotionally intimate with their partner during discussions about the cancer experience.'}, {'measure': 'Relationship Communication', 'timeFrame': '5 years', 'description': 'Perceived self-disclosure. The scale assesses the degree to which they disclose thoughts, information, and feelings about the cancer experience in the past week.\n\nPerceived partner disclosure. The scale assesses the degree to which their partner disclosed thoughts, information, and feelings.\n\nPerceived partner responsiveness. The scale assesses the degree to which the participant felt their partner understood and empathized with their disclosures.Mutual Constructive Communication. This subscale of the Communication Pattern Questionnaire (CPQ) is a 5-item scale that has been adapted.\n\nHolding back. Participants rate the degree to which they held back from talking to their partner about 11 domains of concern.\n\nDemand-Withdraw. The CPQ Demand-Withdraw subscale is a 6-item scale adapted.\n\nMutual Avoidance. The CPQ Mutual Avoidance subscale is an adapted 6-item scale.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Prostate Cancer', 'Sexual Dysfunction and Infertility', 'Sexuality']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Participating in a therapy program may enhance communication and intimacy between men with prostate cancer and their partners.\n\nPURPOSE: This randomized clinical trial is studying how well therapy enhances communication and intimacy for men with early stage prostate cancer and for their partners.', 'detailedDescription': "Aim 1 A. To evaluate the impact of an Intimacy-Enhancing Couples' intervention (IEC) versus a General Health and Wellness Intervention (GHW) and a Usual care control (UC) on patient and partner psychological and relationship outcomes.\n\nB. To determine whether relationship length, pre-intervention relationship satisfaction, and men's pre-intervention masculinity moderate the effects of IEC on couples' psychological and relationship outcomes\n\nAim 2 A. To evaluate whether IEC has an effect on couples' communication and intimacy when compared with GHW and UC and to determine whether changes in relationship communication and intimacy mediate changes in couples' psychological and relationship outcomes.\n\nExploratory Aim:\n\nA. To evaluate the impact of IEC versus GHW on physical activity and fruit and vegetable intake as well as each partner's support for the other partner's adoption of greater physical activity and more fruit and vegetable intake."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has a primary diagnosis of localized prostate cancer (T1, T2, N=0 M=0, T3 N=0 M=0)\n* Patient had surgery or initiated radiation treatment (brachytherapy or external beam radiation) or began pre-radiation Androgen deprivation therapy within the past 12 months.\n* Patient is currently married or living with a partner, with relationship duration at least 1 year\n* Patient and partner live within a 1 hour commuting distance to recruitment site\n* Patient and partner read and speak English\n* Patient has an Impact of Events Scale (IES) score greater than or equal to 16 and/or partner has an IES score greater than or equal to 17.\n\nExclusion Criteria:\n\n* Patient had a previous definitive treatment for prostate cancer\n* Patient has a concurrent diagnosis of another cancer (other than non-melanoma skin cancer)\n* Partner is diagnosed with cancer (other than non-melanoma skin cancer)\n* Patient or partner have a significant hearing impairment'}, 'identificationModule': {'nctId': 'NCT01982058', 'briefTitle': "Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer", 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': "Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer", 'orgStudyIdInfo': {'id': '0220100274'}, 'secondaryIdInfos': [{'id': '0220100274', 'type': 'OTHER', 'domain': 'IRB number'}, {'id': 'NCI-2012-00552', 'type': 'OTHER', 'domain': 'CTRP (Clinical Trails Reporting Program)'}, {'id': '131023', 'type': 'OTHER', 'domain': 'Rutgers Cancer Institute of New Jersey'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intimacy-Enhancing Couples', 'description': "Patients and their partners receive communication and intimacy-enhancing intervention (IEC) once a week comprising the following five 90-minute sessions: Orientation and Stories of the Cancer Experience; Communication and Listening to Partner's concerns; Communication and Coping with Cancer Issues as a Team; Being Supportive to Solve Concerns; and Reflecting on Changes and Future Adaptation.", 'interventionNames': ['Other: communication intervention', 'Other: counseling intervention', 'Other: questionnaire administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'General Health and Wellness', 'description': 'Patients and their partners receive a General Health and Wellness intervention focusing on nutrition and physical activity once a week comprising of five 90-minute sessions: Introduction and Nutrition Basics; Nutrition and Prevention of Recurrence; Nutritional Review and Introduction to Relaxation; Physical Activity Basics; Aerobics and Resistance Exercises and Wrap up.', 'interventionNames': ['Other: counseling intervention', 'Other: nutrition intervention', 'Other: questionnaire administration']}, {'type': 'OTHER', 'label': 'Usual Care', 'description': 'Patients and their partners receive standard psychological and emotional care (usual care \\[UC\\]) (i.e., social work consultations and referral to a psychiatrist or psychologist, if requested or deemed necessary by the attending physician).', 'interventionNames': ['Other: questionnaire administration']}], 'interventions': [{'name': 'communication intervention', 'type': 'OTHER', 'armGroupLabels': ['Intimacy-Enhancing Couples']}, {'name': 'counseling intervention', 'type': 'OTHER', 'armGroupLabels': ['General Health and Wellness', 'Intimacy-Enhancing Couples']}, {'name': 'nutrition intervention', 'type': 'OTHER', 'armGroupLabels': ['General Health and Wellness']}, {'name': 'questionnaire administration', 'type': 'OTHER', 'armGroupLabels': ['General Health and Wellness', 'Intimacy-Enhancing Couples', 'Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'The University Hospital', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '07981', 'city': 'Whippany', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Garden State Urology', 'geoPoint': {'lat': 40.82454, 'lon': -74.4171}}, {'zip': '10022', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Sharon L Manne, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers Cancer Institute of New Jersey'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rutgers Cancer Institute of New Jersey', 'class': 'OTHER'}, {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, {'name': 'Fox Chase Cancer Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Sharon Manne, PhD', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}}