Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-31 @ 4:44 PM
Study NCT ID:
NCT00726635
Status:
UNKNOWN
Last Update Posted:
2009-02-17
First Post:
2008-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Assessment of Preoperative Psychological Intervention on Stress in Women With Gynecological Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2009-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-02-15', 'studyFirstSubmitDate': '2008-07-30', 'studyFirstSubmitQcDate': '2008-07-30', 'lastUpdatePostDateStruct': {'date': '2009-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'psychological, physiological, immunological parameters', 'timeFrame': 'A week before surgery, the day befor surgery, day of hospital discharge, one month after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cancer of Cervix', 'Ovarian Cancer', 'Cancer of Endometrium']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to asses the impact of a tailored preoperative psychological intervention on women with gynecological malignancies on psychological, physiological and immunological parameters', 'detailedDescription': 'Surgery is considered one of the most stressful events in human life. Research indicates that patients show high levels of stress from at least six days before surgery and up to a week post the operation. Stress levels return to normalcy only after several weeks. Research shows that psychological interventions given to women suffering from cancer can improve their coping abilities and overall function, decreases stress levels, enhances adherence to treatments,and increases quality of life and even life expectancy.\n\nWomen enrolled in this study will be divided into two groups: an experimental group and a control group. Both groups will receive standard care. The control group will interact with a nurse for one hour. The experimental group will receive one of two forms of psychological intervention: either a cognitive intervention, or a psychophysiological intervention (tailored to each woman).\n\nMeasurements and Instruments include: 1) Self-report questionnaires, such as:Profile of Mood States (POMS-SF),Coping Inventory (COPE), Life Orientation Test Revised (LOT- R),Stress Level Report, 2) Demographics, 3) Global assessment by the head nurse. 4)Physiological and behavioral measures, such as: vital signs and use of medicine. 5)Hormonal and immunological measures: levels of cortisol in saliva and plasma, levels of catecholamines in plasma, salivary levels of IgA1, and peripheral blood NK cells and lymphocyte phenotyping.6)levels of cytokines including IL-1,2,4,6,10,12, TNF-alpha, Interferon-gamma.\n\nTime intervals for the collection of blood and saliva and the administration of the questionnaires:\n\nDuring the first week after being given the diagnosis and prior to the intervention:Blood \\& saliva, Stress Level Report, POMS-SF, COPE, LOT-R\n\nA day prior to surgery:Blood \\& saliva, Stress Level Report\n\nOn discharge from hospital:Blood \\& saliva, Stress Level Report\n\n30 days after surgery:Stress Level Report,POMS-SF,COPE,LOT-R.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Woman with ovarian, cervical or endometrial cancer/tumor\n* Women who speak Hebrew\n* Women who sign the consent form\n\nExclusion Criteria:\n\n* Women who have received neoadjuvant treatment\n* Women suffering from any form of depression, anxiety or schizophrenia\n* Women suffering from autoimmune or infectious diseases\n* Women taking medications which have immunological effects (steroids ,beta-blockers)\n* Women suffering from dementia or concentration problems'}, 'identificationModule': {'nctId': 'NCT00726635', 'briefTitle': 'The Assessment of Preoperative Psychological Intervention on Stress in Women With Gynecological Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'Assessment of the Impact of Preoperative Stress Reduction on Psychological, Physiological and Immunological Parameters in Women With Gynecological Malignancies - Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '0014-08-RMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Women in this arm will not receive a psychological intervention but rather will have a conversation with a nurse for one hour (attention control).', 'interventionNames': ['Other: Control group']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Cognitive intervention: Women in this arm will receive a cognitive psychological intervention(cognitive technique:self-talk)', 'interventionNames': ['Behavioral: Cognitive intervention']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Psycho-physiological intervention: Women in this arm will receive a psycho-physiological intervention (relaxation and guided imagery)', 'interventionNames': ['Other: psycho-physiological intervention']}], 'interventions': [{'name': 'Cognitive intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Tailored cognitive intervention'], 'description': 'The intervention will last one hour and will include cognitive technique (self-talk). The technique will be demonstrated to the woman, practiced with her, and taped so as to encourage further practice at home.', 'armGroupLabels': ['2']}, {'name': 'Control group', 'type': 'OTHER', 'description': 'A one hour conversation with a nurse', 'armGroupLabels': ['1']}, {'name': 'psycho-physiological intervention', 'type': 'OTHER', 'otherNames': ['tailored psycho-physiological intervention'], 'description': 'The intervention will last an hour and will include a psycho-physiological intervention (relaxation and guided imagery). The technique will be demonstrated to the woman, practiced with her, and taped so as to assure further practice at home', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49100', 'city': 'Petah Tikva', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Opher Caspi, MD PhD', 'role': 'CONTACT', 'email': 'ocaspi@clalit.org.il', 'phone': '972-3937795'}, {'name': 'Mira Livingstone, B.A', 'role': 'CONTACT', 'email': 'mira.livingstone@gmail.com', 'phone': '972-542562083'}, {'name': 'Opher Caspi, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rabin Medical center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'centralContacts': [{'name': 'Opher Caspi, MD PhD', 'role': 'CONTACT', 'email': 'ocaspi@clalit.org.il', 'phone': '972-39377995'}], 'overallOfficials': [{'name': 'Opher Caspi, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director, Integrative Medicine - Rabin Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Academic College of Tel Aviv-Jaffa', 'class': 'OTHER'}, {'name': 'Israel Cancer Association', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Opher Caspi, MD PhD', 'oldOrganization': 'Rabin Medical Center'}}}}