Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-31 @ 12:46 PM
Study NCT ID:
NCT01606033
Status:
COMPLETED
Last Update Posted:
2016-07-28
First Post:
2012-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Stress and Life Quality of Patients Participating in Clinical Trials Versus Patients Non Participating
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-27', 'studyFirstSubmitDate': '2012-05-23', 'studyFirstSubmitQcDate': '2012-05-24', 'lastUpdatePostDateStruct': {'date': '2016-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assess and compare stress and life quality of patients participating to a clinical trial vs patients treated a standard way', 'timeFrame': '4 years', 'description': 'quality of life questionnaire (QLQ C30) Anxiety and depression questionnaire (HADS)'}], 'secondaryOutcomes': [{'measure': 'evaluate links between using adjustment therapy and emotional regulation, and emotional and psychological experience of patients facing one or another situation', 'timeFrame': '4 years', 'description': 'adjustment therapy questionnaire (WCC) emotional regulation questionnaire (DERS 24)'}, {'measure': 'measure and compare variation in time of psychological and emotional consequences during treatment', 'timeFrame': '5 years', 'description': 'emotional regulation (DERS 24)'}, {'measure': 'measure the level of knowledge on the implications of participating in a clinical trial (case)', 'timeFrame': '5 years', 'description': 'assess impact of it on psychological and emotional experience'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stress', 'Life quality', 'adjustment strategy', 'receiving an antitumor treatment', 'within a clinical trial (case)', 'according to a standard treatment (control)'], 'conditions': ['Metastatic Neoplasm', 'Recurrent Hematologic Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to assess anxiety/depression and life quality of patients included in clinical trials versus patients treated in a standard way.', 'detailedDescription': 'This study aims to assess anxiety/depression and life quality of patients included in clinical trials versus patients treated in a standard way A case-control study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient with solid tumor or recurrent hematologic cancer, treated by chemotherapy or targeted therapy evaluated every 2 or 3 cycles; except for clinical trials associating non drug treatment (radiotherapy, surgery...)\n* subject to a 1st, 2nd or 3rd line of antitumor treatment\n\n * a phase 2 open labeled study,\n * a phase 2 or 3 blind randomised study,\n * a phase 2 or 3 open randomised study,\n * a standard treatment non participating to a clinical trial\n* male or female patients ≥ 18 years of age\n* karnovsky ≥ 70 % or OMS ≤ 2\n* recovered from prior toxicities\n* social security covered\n* written informed consent given\n\nExclusion Criteria:\n\n* psychiatric disorders, receiving psychotropic treatment\n* physical or psychological issues\n* forbidden to be included in this study'}, 'identificationModule': {'nctId': 'NCT01606033', 'acronym': 'IPSY', 'briefTitle': 'Study of Stress and Life Quality of Patients Participating in Clinical Trials Versus Patients Non Participating', 'organization': {'class': 'OTHER', 'fullName': 'Centre Oscar Lambret'}, 'officialTitle': 'Psychological and Emotional Impacts of Participation in Oncologic Clinical Trials', 'orgStudyIdInfo': {'id': 'IPSY 0905'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'phase II non randomized study', 'description': 'phase II non randomized study, "Case" : 40 patients description of patients feeling by questionnaires :\n\n* Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction Survey\n* understanding of the implications of participating in a clinical trial', 'interventionNames': ['Other: questionnaires', 'Other: questionnaire']}, {'type': 'OTHER', 'label': 'blind randomized phase II or III study', 'description': 'blind randomized phase II or III study: "control" : 40 patients description of patients feeling by questionnaires :\n\n* Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction Survey\n* understanding of the implications of participating in a clinical trial', 'interventionNames': ['Other: questionnaires', 'Other: questionnaire']}, {'type': 'OTHER', 'label': 'open randomized phase II or III study', 'description': 'open randomized phase II or III study : 40 patients description of patients feeling by questionnaires : Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction Survey\n\n-understanding of the implications of participating in a clinical trial', 'interventionNames': ['Other: questionnaires', 'Other: questionnaire']}, {'type': 'OTHER', 'label': 'receiving standard treatment', 'description': 'receiving standard treatment : 120 patients description of patients feeling by questionnaires :\n\n-understanding of the implications of participating in a clinical trial', 'interventionNames': ['Other: questionnaires']}], 'interventions': [{'name': 'questionnaires', 'type': 'OTHER', 'description': 'Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction survey', 'armGroupLabels': ['blind randomized phase II or III study', 'open randomized phase II or III study', 'phase II non randomized study', 'receiving standard treatment']}, {'name': 'questionnaire', 'type': 'OTHER', 'description': 'understanding of the implications of participating in a clinical trial', 'armGroupLabels': ['blind randomized phase II or III study', 'open randomized phase II or III study', 'phase II non randomized study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59020', 'city': 'Lille', 'state': 'Hauts-de-France', 'country': 'France', 'facility': 'Oscar Lambret Center', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '49033', 'city': 'Angers', 'country': 'France', 'facility': 'Paul PAPIN Center', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '14076', 'city': 'Caen', 'country': 'France', 'facility': 'François Baclesse Center', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '49300', 'city': 'Cholet', 'country': 'France', 'facility': 'CHOLET Hospital', 'geoPoint': {'lat': 47.05893, 'lon': -0.87974}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'Georges-François LECLERC Center', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Léon BERARD Center', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': "Val D'AURELLE Center", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '51056', 'city': 'Reims', 'country': 'France', 'facility': 'Jean GODINOT Institut', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}], 'overallOfficials': [{'name': 'Stéphanie CLISANT', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Oscar Lambret Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Oscar Lambret', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}