The Assessment of Preoperative Psychological Intervention on Stress in Women With Gynecological Malignancies
NCT ID: NCT00726635
Last Updated: 2009-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2008-08-31
2009-08-31
Brief Summary
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Detailed Description
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Women 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).
Measurements 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.
Time intervals for the collection of blood and saliva and the administration of the questionnaires:
During the first week after being given the diagnosis and prior to the intervention:Blood \& saliva, Stress Level Report, POMS-SF, COPE, LOT-R
A day prior to surgery:Blood \& saliva, Stress Level Report
On discharge from hospital:Blood \& saliva, Stress Level Report
30 days after surgery:Stress Level Report,POMS-SF,COPE,LOT-R.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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1
Women in this arm will not receive a psychological intervention but rather will have a conversation with a nurse for one hour (attention control).
Control group
A one hour conversation with a nurse
2
Cognitive intervention: Women in this arm will receive a cognitive psychological intervention(cognitive technique:self-talk)
Cognitive intervention
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.
3
Psycho-physiological intervention: Women in this arm will receive a psycho-physiological intervention (relaxation and guided imagery)
psycho-physiological intervention
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
Interventions
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Cognitive intervention
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.
Control group
A one hour conversation with a nurse
psycho-physiological intervention
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Women who speak Hebrew
* Women who sign the consent form
Exclusion Criteria
* Women suffering from any form of depression, anxiety or schizophrenia
* Women suffering from autoimmune or infectious diseases
* Women taking medications which have immunological effects (steroids ,beta-blockers)
* Women suffering from dementia or concentration problems
18 Years
70 Years
FEMALE
No
Sponsors
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Academic College of Tel Aviv-Jaffa
OTHER
Israel Cancer Association
OTHER
Rabin Medical Center
OTHER
Responsible Party
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Rabin Medical Center
Principal Investigators
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Opher Caspi, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Director, Integrative Medicine - Rabin Medical Center
Locations
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Rabin Medical center
Petah Tikva, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0014-08-RMC
Identifier Type: -
Identifier Source: org_study_id
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