Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-24 @ 7:50 AM
Study NCT ID:
NCT01817335
Status:
COMPLETED
Last Update Posted:
2015-06-02
First Post:
2013-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psycho-Educational Program in Increasing Knowledge and Satisfaction and Decreasing Distress in Younger Patients With Cancer Receiving Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000067250', 'term': 'Psychiatric Rehabilitation'}, {'id': 'D018479', 'term': 'Early Intervention, Educational'}, {'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-29', 'studyFirstSubmitDate': '2013-03-19', 'studyFirstSubmitQcDate': '2013-03-20', 'lastUpdatePostDateStruct': {'date': '2015-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects who are unable to attend all the sessions', 'timeFrame': 'Up to 30 days'}], 'secondaryOutcomes': [{'measure': 'Mean of the YA (Young Adult) Patient Satisfaction evaluations', 'timeFrame': 'Up to 30 days', 'description': 'A questionnaire was developed to measure participant satisfaction with the format and material of the psycho-educational program. Satisfaction measures will be provided for completion at the end of sessions 2 through 5 and 30 days post intervention. Changes in the mean of the Questionnaire responses will be analyzed using a paired t-test and calculations of simple frequency and descriptive statistics will be used to summarize the data and program evaluations.'}, {'measure': 'Mean of the Pre/Post Test Knowledge Questionnaire', 'timeFrame': 'Up to 30 days', 'description': 'A questionnaire was developed based on the psycho-educational material to assess increases in knowledge and retention. The questionnaire will be administered pre-intervention and 30 days post-intervention. Additionally, relevant items from the questionnaire will be administered at the end of the relevant educational session. For instance, self image questions from the questionnaire will be administered at the end of the self-image session in addition to the pre and post administration of the entire questionnaire. Changes in the mean of the Questionnaire responses will be analyzed using a paired t-test and calculations of simple frequency and descriptive statistics will be used to summarize the data and program evaluations.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Malignant Neoplasm', 'Psychosocial Effects of Cancer and Its Treatment']}, 'descriptionModule': {'briefSummary': 'This pilot clinical trial studies psycho-educational program in increasing knowledge and satisfaction and decreasing distress in younger patients with cancer receiving treatment. Psycho-educational program may increase knowledge and satisfaction and decrease distress in younger patients with cancer receiving treatment', 'detailedDescription': "PRIMARY OBJECTIVES:\n\nI. Providing a psycho-educational group to young adults while examining the feasibility of such a group with patients on treatment.\n\nII. Examining effectiveness of the program through evaluating pre-post changes in participant distress, evaluating increases in participant' knowledge regarding disease issues and coping, and evaluating participant satisfaction.\n\nOUTLINE:\n\nPatients undergo psycho-educational program comprising medical/symptom management and communication with a medical team, coping skills, self image, and relationships and communication for 1.5 hours once weekly for 6 weeks.\n\nAfter completion of study treatment, patients are followed up for 30 days."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently in active treatment (diagnosed and receiving treatment within 2 weeks of initial study enrollment; active treatment includes currently receiving any of the following: chemotherapy, radiation therapy, maintenance drugs, surgery, clinical trial enrollment, or current relapse/secondary malignancy)\n* Inpatient or outpatient\n* Cancer diagnosis\n* Physician approval\n* Informed consent\n\nExclusion Criteria:\n\n* Significant psychiatric or developmental issues, as determined by screening interview conducted by psychologist or clinical social worker\n* Currently off treatment (longer than 2 weeks at the time of enrollment)\n* In isolation or with isolation precautions\n* Non-English speaking'}, 'identificationModule': {'nctId': 'NCT01817335', 'briefTitle': 'Psycho-Educational Program in Increasing Knowledge and Satisfaction and Decreasing Distress in Younger Patients With Cancer Receiving Treatment', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'Pilot Study of Psycho-Educational Group for Young Adults (YA) on Treatment: Impact on Knowledge, Distress, and Satisfaction', 'orgStudyIdInfo': {'id': '13128'}, 'secondaryIdInfos': [{'id': 'NCI-2013-00589', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supportive care (psycho-educational program)', 'description': 'Patients participate in a psycho-educational program focused on medical/symptom management and communication with a medical team, coping skills, self image, and relationships and communication for 1.5 hours once weekly for 6 weeks.', 'interventionNames': ['Procedure: psychosocial assessment and care', 'Other: educational intervention', 'Other: communication skills training', 'Other: questionnaire administration']}], 'interventions': [{'name': 'psychosocial assessment and care', 'type': 'PROCEDURE', 'otherNames': ['psychosocial assessment', 'psychosocial assessment/care', 'psychosocial care', 'psychosocial care/assessment', 'psychosocial studies'], 'description': 'Participate in psycho-educational program', 'armGroupLabels': ['Supportive care (psycho-educational program)']}, {'name': 'educational intervention', 'type': 'OTHER', 'otherNames': ['intervention, educational'], 'description': 'Participate in psycho-educational program', 'armGroupLabels': ['Supportive care (psycho-educational program)']}, {'name': 'communication skills training', 'type': 'OTHER', 'description': 'Participate in psycho-educational program', 'armGroupLabels': ['Supportive care (psycho-educational program)']}, {'name': 'questionnaire administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Supportive care (psycho-educational program)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}], 'overallOfficials': [{'name': 'Jeanelle Folbrecht', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}