Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2026-02-05 @ 7:30 AM
Study NCT ID:
NCT02070250
Status:
COMPLETED
Last Update Posted:
2021-09-17
First Post:
2014-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stress Management for Cancer Patients: How Well Does it Work? (C2H-D)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013315', 'term': 'Stress, Psychological'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-10', 'studyFirstSubmitDate': '2014-02-20', 'studyFirstSubmitQcDate': '2014-02-24', 'lastUpdatePostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline to post-intensive intervention assessment in pain using the 13-item Brief Pain Questionnaire (BPQ)', 'timeFrame': 'Baseline, up to 18 weeks', 'description': 'The intensive intervention length can vary by location from 4 to 18 weeks.'}, {'measure': 'Change from baseline to post-intensive intervention assessment in fatigue using the 7-item Fatigue Severity Index (FSI)', 'timeFrame': 'Baseline, up to 18 weeks', 'description': 'The intensive intervention length can vary by location from 4 to 18 weeks.'}, {'measure': 'Change from baseline to post-intensive intervention assessment in sleep using the 24-item Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'Baseline, up to 18 weeks', 'description': 'The intensive intervention length can vary by location from 4 to 18 weeks.'}], 'primaryOutcomes': [{'measure': 'Change from baseline to post-intensive intervention assessment in mood on the 65-item Profile of Mood States (POMS)', 'timeFrame': 'Baseline, up to 18 weeks', 'description': 'The intensive intervention length can vary by location from 4 to 18 weeks.'}, {'measure': 'Change from baseline to post-intensive intervention assessment in cancer-specific stress on the 20-item Impact of Events Scale (IES)', 'timeFrame': 'Baseline, up to 18 weeks', 'description': 'The intensive intervention length can vary by location from 4 to 18 weeks.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline to post-intensive intervention assessment in social support using the 20 item Perceived Social Support from Your Family Scale (PSS-Fa)', 'timeFrame': 'Baseline, up to 18 weeks', 'description': 'The intensive intervention length can vary by location from 4 to 18 weeks.'}, {'measure': 'Change from baseline to post-intensive intervention assessment in physical activity on the 3-item Physical Activity Rating Scale (PAR)', 'timeFrame': 'Baseline, up to 18 weeks', 'description': 'The intensive intervention length can vary by location from 4 to 18 weeks.'}, {'measure': 'Change from baseline to post-intensive intervention assessment in diet on the 23-item Food Habits Questionnaire (FHQ)', 'timeFrame': 'Baseline, up to 18 weeks', 'description': 'The intensive intervention length can vary by location from 4 to 18 weeks.'}, {'measure': 'Change from baseline to post-intensive intervention assessment in sexual health on the 4-item Your Sexual Life questionnaire', 'timeFrame': 'Baseline, up to 18 weeks', 'description': 'The intensive intervention length can vary by location from 4 to 18 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stress management', 'Coping skills', 'Recently diagnosed cancer patients', 'Intervention, Psychological'], 'conditions': ['Mood', 'Stress, Psychological']}, 'referencesModule': {'references': [{'pmid': '30024215', 'type': 'BACKGROUND', 'citation': 'Ashmore JA, Ditterich KW, Conley CC, Wright MR, Howland PS, Huggins KL, Cooreman J, Andrews PS, Nicholas DR, Roberts L, Hewitt L, Scales JN, Delap JK, Gray CA, Tyler LA, Collins C, Whiting CM, Brothers BM, Ryba MM, Andersen BL. Evaluating the effectiveness and implementation of evidence-based treatment: A multisite hybrid design. Am Psychol. 2019 May-Jun;74(4):459-473. doi: 10.1037/amp0000309. Epub 2018 Jul 19.'}]}, 'descriptionModule': {'briefSummary': 'Psychological interventions for cancer patients have been tested and found to reduce stress and improve quality of life. These interventions have been tested at academic medical centers but have not been available for use by community mental health professionals. One such intervention is the Biobehavioral Intervention (BBI), developed by Professor Barbara L. Andersen and colleagues at Ohio State (OSU). Current funding has enabled the investigators to train mental health professionals from across the country to deliver the BBI at their institution. Recently diagnosed cancer patients who are participating in the BBI group at these institutions may participate in a research study completing self report measures asking about psychological and behavioral outcomes (for example, mood, stress, diet and physical activity). The investigators hypothesize that individuals participating in the intervention will report improvements in outcomes, such as reduced stress and improved mood, reduced symptoms of the disease and treatment, etc., after completing the intervention and continue to report these improvements up to 6 months after the group ends. OSU will coordinate this data collection project but information about participating sites is listed in http://clinicaltrials.gov.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recent initial diagnosis of cancer without metastatic disease\n* Able to speak/read English\n\nExclusion Criteria: Those with concurrent diagnoses of\n\n* Organic brain syndrome\n* Dementia\n* Mental retardation\n* non-English speaking\n* Significant sensory deficit\n* Severe mental illness (e.g., schizophrenia, psychotic disorder)'}, 'identificationModule': {'nctId': 'NCT02070250', 'acronym': 'C2H-D', 'briefTitle': 'Stress Management for Cancer Patients: How Well Does it Work? (C2H-D)', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University Comprehensive Cancer Center'}, 'officialTitle': 'Examination of a Stress Management Intervention for Cancer Patients as Delivered by Community Mental Health Professionals', 'orgStudyIdInfo': {'id': 'OSU-13127'}, 'secondaryIdInfos': [{'id': 'R25CA163197', 'link': 'https://reporter.nih.gov/quickSearch/R25CA163197', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'From Cancer to Health (C2H-D)', 'description': 'Individuals participating in the From Cancer to Health (C2H-D) Stress Management Psychological Intervention', 'interventionNames': ['Behavioral: From Cancer to Health (C2H-D)']}], 'interventions': [{'name': 'From Cancer to Health (C2H-D)', 'type': 'BEHAVIORAL', 'otherNames': ['C2H', 'Biobehavioral Intervention', 'BBI', 'Stress management'], 'description': 'From Cancer to Health gives people with cancer the information and tools they need to manage their stress to improve their health throughout the cancer journey. Each institution involved in this study will implement the core techniques of the C2H-D Intervention but may alter the format somewhat to meet their patient population needs (e.g., shorten hourly 18 week intervention into 2-hour 9 week intervention).', 'armGroupLabels': ['From Cancer to Health (C2H-D)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36830', 'city': 'Auburn', 'state': 'Alabama', 'country': 'United States', 'facility': 'Cancer Center of East Alabama Medical Center', 'geoPoint': {'lat': 32.60986, 'lon': -85.48078}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Comprehensive Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': "Providence Saint John's Health Center", 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '96161', 'city': 'Truckee', 'state': 'California', 'country': 'United States', 'facility': 'Tahoe Forest Cancer Center', 'geoPoint': {'lat': 39.32796, 'lon': -120.18325}}, {'zip': '60521', 'city': 'Hinsdale', 'state': 'Illinois', 'country': 'United States', 'facility': 'Wellness House', 'geoPoint': {'lat': 41.80086, 'lon': -87.93701}}, {'zip': '60062', 'city': 'Northbrook', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cancer Wellness Center', 'geoPoint': {'lat': 42.12753, 'lon': -87.82895}}, {'zip': '47303', 'city': 'Muncie', 'state': 'Indiana', 'country': 'United States', 'facility': 'IU Health Ball Memorial Hospital', 'geoPoint': {'lat': 40.19338, 'lon': -85.38636}}, {'zip': '52803', 'city': 'Davenport', 'state': 'Iowa', 'country': 'United States', 'facility': 'Genesis Health Center', 'geoPoint': {'lat': 41.52364, 'lon': -90.57764}}, {'zip': '52803', 'city': 'Davenport', 'state': 'Iowa', 'country': 'United States', 'facility': "Unity Point Health/Gilda's Club Quad Cities", 'geoPoint': {'lat': 41.52364, 'lon': -90.57764}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky Markey Cancer Center', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'OSU Stephanie Spielman Comprehensive Breast Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '17822', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Medical Center', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Seton UT Southwestern', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Regional Medical Center at Plano, Texas', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}], 'overallOfficials': [{'name': 'Barbara L Andersen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Barbara Andersen', 'investigatorAffiliation': 'Ohio State University Comprehensive Cancer Center'}}}}