Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-28 @ 10:10 AM
Study NCT ID:
NCT00830635
Status:
COMPLETED
Last Update Posted:
2015-06-16
First Post:
2009-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimedia Educational Program for Patients With Early-Stage Prostate Cancer or Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018479', 'term': 'Early Intervention, Educational'}, {'id': 'D000067250', 'term': 'Psychiatric Rehabilitation'}], 'ancestors': [{'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1800}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-12', 'studyFirstSubmitDate': '2009-01-27', 'studyFirstSubmitQcDate': '2009-01-27', 'lastUpdatePostDateStruct': {'date': '2015-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cancer-specific distress'}, {'measure': 'Emotional quality of life'}, {'measure': 'Physical functioning'}, {'measure': 'Interpersonal functioning'}, {'measure': 'Benefit-finding'}, {'measure': 'Decisional conflict (projects 1 and 2)'}, {'measure': 'Regret (projects 1 and 2)'}, {'measure': 'Fear of recurrence (project 3)'}, {'measure': 'Practical concerns (project 3)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['long-term effects of cancer treatment', 'psychosocial effects of cancer and its treatment', 'depression', 'stage IA breast cancer', 'stage IB breast cancer', 'stage II breast cancer', 'stage I prostate cancer', 'stage II prostate cancer'], 'conditions': ['Breast Cancer', 'Depression', 'Long-term Effects of Cancer Treatment', 'Prostate Cancer', 'Psychosocial Effects of Cancer and Its Treatment']}, 'descriptionModule': {'briefSummary': 'RATIONALE: A multimedia educational program may help patients with newly diagnosed prostate cancer and breast cancer reduce distress, make informed treatment decisions, and improve quality of life.\n\nPURPOSE: This randomized clinical trial is studying how well a multimedia educational program works in patients with early-stage prostate cancer or breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine whether an innovative multimedia educational program will help newly diagnosed prostate (project 1) and breast (project 2) cancer patients prepare for their journey as cancer patients, promote informed treatment decision-making and reduce cancer-specific distress, and among breast cancer patients at re-entry, facilitate an informed re-entry transition to cancer survivorship and reduce cancer-specific distress (project 3).\n* Determine whether having Cancer Information Service (CIS) Information Specialists make a scheduled telephone callback to callers in project 3 will augment and support use of the CIS Research Consortium (CISRC) multimedia educational programs and further enhance the study outcomes examined in this program of research.\n* Determine whether the hypothesized mediational variables account for significant intervention effects in each of the three component projects.\n* Examine potential moderator variables to assess potential differences in intervention efficacy by selected subgroups (e.g., age, education) within each component project.\n* Conduct an in-depth tracking study of utilization patterns for a detailed description of different patterns of use, as well as elucidating those components or modules within the program that had differential utilization by participants.\n* Assist the CIS and other similar cancer information systems in disseminating one or more of the CISRC interventions should they prove effective in this program of research.\n\nSecondary\n\n* Conduct secondary analyses across projects (i.e., perceived need for and benefit from the CISRC interventions and intervention efficacy across three high priority cancer patient populations) that will be made possible by the use of a common theoretical framework, the same or similar intervention and research design across projects, and a common set of endpoints.\n\nOUTLINE: This is a multicenter study.\n\nPatients are assessed by demographic questions and a baseline interview conducted by Cancer Information Service (CIS) Information Specialists.\n\nPatients are randomized to 1 of 3 intervention groups:\n\n* Group 1: Patients receive a mailing containing standard CIS print materials. In project 1, patients receive " Treatment Choices for Men with Early-Stage Prostate Cancer" and "What You Need to Know About Prostate Cancer". In project 2, patients receive "What You Need to Know About Breast Cancer" and "Surgery Choices for Women with Early-Stage Breast Cancer". In project 3, patients receive "Facing Forward: Life After Cancer Treatment" and "What You Need to Know About Breast Cancer".\n* Group 2: Patients receive mailings appropriate to their project as in group 1. Patients also receive the multimedia program via the Internet or CD-ROM.\n* Group 3: In project 3 only, patients receive mailings appropriate to their project as in group 1 and the multimedia program as in group 2. Patients also receive a CIS callback intervention at 10-14 days from trained Information Specialists from the CIS.\n\nAfter completion of study therapy, patients are followed at 2 and 9 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Patients are diagnosed with 1 of the following:\n\n * Diagnosis of prostate cancer (project 1)\n\n * Early-stage disease\n * Previously untreated disease or treatment status unknown\n * Diagnosis of breast cancer (projects 2-3)\n\n * Early-stage disease\n * No ductal carcinoma in situ or lobular carcinoma in situ\n * Inflammatory breast cancer allowed (project 2)\n * Previously untreated disease, receiving concurrent treatment, previously treated disease, or treatment status unknown\n\n * No more than 30 days since completion of treatment OR no more than 6 months post-treatment (project 3)\n\nPATIENT CHARACTERISTICS:\n\n* Has access to a computer\n* Willing to provide mailing address and telephone number\n* Must be active information-seekers who have already called the CIS\n* Understands English\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00830635', 'briefTitle': 'Multimedia Educational Program for Patients With Early-Stage Prostate Cancer or Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Cancer Information Service Research Consortium: Years 2006-2011 Program Narrative and Overview', 'orgStudyIdInfo': {'id': '08-0498'}, 'secondaryIdInfos': [{'id': 'AMCCRC-08-0498'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'educational intervention', 'type': 'OTHER'}, {'name': 'informational intervention', 'type': 'OTHER'}, {'name': 'internet-based intervention', 'type': 'OTHER'}, {'name': 'questionnaire administration', 'type': 'OTHER'}, {'name': 'study of socioeconomic and demographic variables', 'type': 'OTHER'}, {'name': 'survey administration', 'type': 'OTHER'}, {'name': 'psychosocial assessment and care', 'type': 'PROCEDURE'}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Sylvester Comprehensive Cancer Center - Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '98109-1024', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Alfred Marcus, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AMC Cancer Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}