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| Sponsors and Collaborators: |
Rabin Medical Center Academic College of Tel Aviv-Jaffa Israel Cancer Association |
|---|---|
| Information provided by: | Rabin Medical Center |
| ClinicalTrials.gov Identifier: | NCT00726635 |
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer of Cervix Ovarian Cancer Cancer of Endometrium |
Behavioral: Cognitive intervention Other: Control group Other: psycho-physiological intervention |
Phase III |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Assessment of the Impact of Preoperative Stress Reduction on Psychological, Physiological and Immunological Parameters in Women With Gynecological Malignancies - Prospective Randomized Controlled Trial |
| Estimated Enrollment: | 60 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Women in this arm will not receive a psychological intervention but rather will have a conversation with a nurse for one hour (attention control).
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Other: Control group
A one hour conversation with a nurse
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2: Experimental
Cognitive intervention: Women in this arm will receive a cognitive psychological intervention(cognitive technique:self-talk)
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Behavioral: 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.
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3: Experimental
Psycho-physiological intervention: Women in this arm will receive a psycho-physiological intervention (relaxation and guided imagery)
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Other: 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
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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. 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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Opher Caspi, MD PhD | 972-39377995 | ocaspi@clalit.org.il |
| Israel | |
| Rabin Medical center | Recruiting |
| Petah Tikva, Israel, 49100 | |
| Contact: Opher Caspi, MD PhD 972-3937795 ocaspi@clalit.org.il | |
| Contact: Mira Livingstone, B.A 972-542562083 mira.livingstone@gmail.com | |
| Principal Investigator: Opher Caspi, MD PhD | |
| Principal Investigator: | Opher Caspi, MD PhD | Director, Integrative Medicine - Rabin Medical Center |
More Information
| Responsible Party: | Rabin Medical Center ( Opher Caspi, MD PhD ) |
| Study ID Numbers: | 0014-08-RMC |
| Study First Received: | July 30, 2008 |
| Last Updated: | February 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00726635 History of Changes |
| Health Authority: | Israel: Ethics Commission |
|
Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Stress Uterine Diseases Endocrine System Diseases Endometrial Cancer Urogenital Neoplasms Ovarian Diseases |
Uterine Cervical Neoplasms Genital Diseases, Female Endometrial Neoplasms Uterine Cervical Diseases Ovarian Cancer Uterine Neoplasms Endocrinopathy Endocrine Gland Neoplasms |
|
Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Uterine Diseases Urogenital Neoplasms Ovarian Diseases Adnexal Diseases |
Uterine Cervical Neoplasms Genital Diseases, Female Endometrial Neoplasms Neoplasms Uterine Cervical Diseases Neoplasms by Site Uterine Neoplasms Endocrine Gland Neoplasms |
