Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-28 @ 5:39 AM
Study NCT ID:
NCT00708968
Status:
COMPLETED
Last Update Posted:
2015-06-16
First Post:
2008-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prostate Cancer: Family Care for Patients and Spouses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D003142', 'term': 'Communication'}], '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 263}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-15', 'studyFirstSubmitDate': '2008-07-01', 'studyFirstSubmitQcDate': '2008-07-02', 'lastUpdatePostDateStruct': {'date': '2015-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life', 'timeFrame': 'Baseline, 4, 8 and 12 months'}], 'secondaryOutcomes': [{'measure': 'Threat appraisal', 'timeFrame': 'Baseline, 4, 8 and 12 months'}, {'measure': 'Uncertainty', 'timeFrame': 'Baseline, 4, 8 and 12 months'}, {'measure': 'Hopelessness', 'timeFrame': 'Baseline, 4, 8 and 12 months'}, {'measure': 'Coping', 'timeFrame': 'Baseline, 4, 8 and 12 months'}, {'measure': 'Family Communication', 'timeFrame': 'Baseline, 4, 8 and 12 months'}, {'measure': 'Self-Efficacy', 'timeFrame': 'Baseline, 4, 8 and 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['randomized clinical trial', 'coping', 'quality of life', 'family', 'family caregiver', 'cancer survivorship', 'communication', 'uncertainty', 'support', 'family education', 'Caregivers'], 'conditions': ['Prostate Cancer', 'Quality of Life', 'Cancer Survivorship']}, 'referencesModule': {'references': [{'pmid': '16676337', 'type': 'BACKGROUND', 'citation': 'Northouse LL, Rosset T, Phillips L, Mood D, Schafenacker A, Kershaw T. Research with families facing cancer: the challenges of accrual and retention. Res Nurs Health. 2006 Jun;29(3):199-211. doi: 10.1002/nur.20128.'}, {'pmid': '19816159', 'type': 'BACKGROUND', 'citation': "Harden J, Falahee M, Bickes J, Schafenacker A, Walker J, Mood D, Northouse L. Factors associated with prostate cancer patients' and their spouses' satisfaction with a family-based intervention. Cancer Nurs. 2009 Nov-Dec;32(6):482-92. doi: 10.1097/NCC.0b013e3181b311e9."}, {'pmid': '18830672', 'type': 'BACKGROUND', 'citation': 'Kershaw TS, Mood DW, Newth G, Ronis DL, Sanda MG, Vaishampayan U, Northouse LL. Longitudinal analysis of a model to predict quality of life in prostate cancer patients and their spouses. Ann Behav Med. 2008 Oct;36(2):117-28. doi: 10.1007/s12160-008-9058-3. Epub 2008 Sep 16.'}, {'pmid': '20927648', 'type': 'BACKGROUND', 'citation': 'Song L, Northouse LL, Braun TM, Zhang L, Cimprich B, Ronis DL, Mood DW. Assessing longitudinal quality of life in prostate cancer patients and their spouses: a multilevel modeling approach. Qual Life Res. 2011 Apr;20(3):371-81. doi: 10.1007/s11136-010-9753-y. Epub 2010 Oct 8.'}, {'pmid': '20967920', 'type': 'BACKGROUND', 'citation': 'Song L, Northouse LL, Zhang L, Braun TM, Cimprich B, Ronis DL, Mood DW. Study of dyadic communication in couples managing prostate cancer: a longitudinal perspective. Psychooncology. 2012 Jan;21(1):72-81. doi: 10.1002/pon.1861. Epub 2010 Oct 22.'}, {'pmid': '17999405', 'type': 'RESULT', 'citation': 'Northouse LL, Mood DW, Schafenacker A, Montie JE, Sandler HM, Forman JD, Hussain M, Pienta KJ, Smith DC, Kershaw T. Randomized clinical trial of a family intervention for prostate cancer patients and their spouses. Cancer. 2007 Dec 15;110(12):2809-18. doi: 10.1002/cncr.23114.'}, {'pmid': '17635953', 'type': 'RESULT', 'citation': "Northouse LL, Mood DW, Montie JE, Sandler HM, Forman JD, Hussain M, Pienta KJ, Smith DC, Sanda MG, Kershaw T. Living with prostate cancer: patients' and spouses' psychosocial status and quality of life. J Clin Oncol. 2007 Sep 20;25(27):4171-7. doi: 10.1200/JCO.2006.09.6503. Epub 2007 Jul 16."}], 'seeAlsoLinks': [{'url': 'http://www.cancer.med.umich.edu/', 'label': 'University of Michigan Comprehensive Cancer Center website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if a family-based intervention (The FOCUS Program) can improve the long-term quality of life and other psycho-social outcomes of men with prostate cancer and their spouses.', 'detailedDescription': 'The purpose of this study was to determine if a family-based intervention (The FOCUS Program) could improve the long-term quality of life and other psycho-social outcomes of men with prostate cancer and their spouse/partners. Aim 1. The first aim was to determine if the family intervention could improve several proximal clinical outcomes (less negative appraisal of illness or caregiving, less uncertainty, less hopelessness, better family communication, higher self-efficacy, and more problem-focused coping) and improve the distal clinical outcome, quality of life, in a culturally and economically diverse sample of men with prostate cancer and their spouses. Aim 2. The second aim was to test a stress-coping model designed to predict which prostate cancer patients and their spouses are at higher risk of poorer long-term quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of prostate cancer\n* Willing spousal partner\n* Speaks and understands English\n* Mentally and physically able to participate\n* Minimum life expectancy of 12 months\n* Lives within 70 miles\n\nExclusion Criteria:\n\n* Multiple primary cancers\n* Watchful waiting status\n* Spouse with cancer diagnosis in previous year'}, 'identificationModule': {'nctId': 'NCT00708968', 'briefTitle': 'Prostate Cancer: Family Care for Patients and Spouses', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Prostate Cancer: Family Care for Patients and Spouses', 'orgStudyIdInfo': {'id': 'R01CA090739', 'link': 'https://reporter.nih.gov/quickSearch/R01CA090739', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01CA090739', 'link': 'https://reporter.nih.gov/quickSearch/R01CA090739', 'type': 'NIH'}, {'id': 'UMCC 0080'}, {'id': 'IRBMED 2001-0091'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FOCUS Intervention', 'description': 'Dyads randomized to this arm received the FOCUS Program, 3 home visits and 2 phone calls by trained nurses.', 'interventionNames': ['Behavioral: FOCUS Program']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care'}], 'interventions': [{'name': 'FOCUS Program', 'type': 'BEHAVIORAL', 'otherNames': ['Prostate Cancer Patient and Spouse Intervention', 'Family-based intervention'], 'description': 'Supportive, educative sessions with patients and spouses.', 'armGroupLabels': ['FOCUS Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Comprehensive Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University-Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'William Beaumont Hospitals', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}], 'overallOfficials': [{'name': 'Laurel L Northouse, PhD RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wayne State University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Laurel L. Northouse PhD/ Professor of Nursing', 'oldOrganization': 'University of Michigan'}}}}