Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-30 @ 11:53 AM
Study NCT ID:
NCT01594593
Status:
COMPLETED
Last Update Posted:
2012-11-19
First Post:
2012-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acceptance-Based Treatment for Prostate Cancer Distress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D001519', 'term': 'Behavior'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064869', 'term': 'Acceptance and Commitment Therapy'}], 'ancestors': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-16', 'studyFirstSubmitDate': '2012-04-23', 'studyFirstSubmitQcDate': '2012-05-07', 'lastUpdatePostDateStruct': {'date': '2012-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of dropouts', 'timeFrame': '6 months', 'description': 'Because this is a pilot study to determine feasibility, one of the primary outcomes is the number of participants who drop out of the active treatment arm.'}, {'measure': 'Number of refusals', 'timeFrame': '6 months', 'description': 'Because this is a pilot study to determine feasibility, one of the primary outcomes is the number of participants who refuse the active treatment arm.'}], 'secondaryOutcomes': [{'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': 'baseline, post intervention, 2 weeks post intervention, 3 months post intervention'}, {'measure': 'Memorial Anxiety Scale for Prostate Cancer', 'timeFrame': 'baseline, post intervention, 2 weeks post intervention, 3 months post intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prostate cancer', 'behavioral', 'acceptance and commitment therapy', 'distress'], 'conditions': ['Early Stage Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Prostate cancer (PCa) is the most common type of cancer in men and the second leading cause of death in American men. Those diagnosed with localized prostate cancer encounter three sources of psychological distress: 1) diagnosis itself, 2) treatment decision making, and 3) the often life-altering side effects of treatment. In addition, patients who choose to undergo active surveillance which focuses on monitoring cancer in lieu of treatment, experience distress related to living with cancer. Acceptance and Commitment Therapy (ACT) is an established psychosocial intervention that has been used extensively for mental health treatment and has shown benefits for various chronic conditions. ACT is a behavioral intervention that focuses on tolerating distress and improving function. This pilot study is designed to test the feasibility of ACT for distress reduction and improved quality of life in patients recently diagnosed with early-stage, localized PCa.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Localized prostate cancer in Stages I or II\n* Ability to give informed consent\n* Age 18 to 80 years old\n* Willingness to come in for a day long intervention\n\nExclusion Criteria:\n\n* Acute psychosis\n* Suicidal ideation\n* Homicidal ideation\n* Active substance abuse\n* Dementia'}, 'identificationModule': {'nctId': 'NCT01594593', 'briefTitle': 'Acceptance-Based Treatment for Prostate Cancer Distress', 'organization': {'class': 'OTHER', 'fullName': 'Veterans Medical Research Foundation'}, 'officialTitle': 'Pilot Study of an Acceptance and Commitment Therapy Workshop for Distress and Decision Making in Early Stage Prostate Cancer in Veterans', 'orgStudyIdInfo': {'id': '110353'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acceptance and Commitment Therapy', 'description': 'Group-based behavioral workshop to address cancer-related distress', 'interventionNames': ['Behavioral: Acceptance and Commitment Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'treatment as usual'}], 'interventions': [{'name': 'Acceptance and Commitment Therapy', 'type': 'BEHAVIORAL', 'description': 'group-based behavioral workshop to address cancer-related distress', 'armGroupLabels': ['Acceptance and Commitment Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'VA San Diego Healthcare System', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Niloofar Afari, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Diego Veterans Healthcare System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Veterans Medical Research Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alliant International University', 'class': 'OTHER'}, {'name': 'University of California, San Diego', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}