The Assessment of Preoperative Psychological Intervention on Stress in Women With Gynecological Malignancies
Recruitment status was Recruiting
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| 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 |
- psychological, physiological, immunological parameters [ Time Frame: A week before surgery, the day befor surgery, day of hospital discharge, one month after surgery ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Active Comparator: 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).
|
Other: Control group
A one hour conversation with a nurse
Other Name: Control group
|
|
Experimental: 2
Cognitive intervention: Women in this arm will receive a cognitive psychological intervention(cognitive technique:self-talk)
|
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.
Other Name: Tailored cognitive intervention
|
|
Experimental: 3
Psycho-physiological intervention: Women in this arm will receive a psycho-physiological intervention (relaxation and guided imagery)
|
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
Other Name: tailored psycho-physiological intervention
|
Detailed Description:
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:
- Woman with ovarian, cervical or endometrial cancer/tumor
- Women who speak Hebrew
- Women who sign the consent form
Exclusion Criteria:
- Women who have received neoadjuvant treatment
- 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
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
No publications provided
| Responsible Party: | Opher Caspi, MD PhD, Rabin Medical Center |
| ClinicalTrials.gov Identifier: | NCT00726635 History of Changes |
| Other Study ID Numbers: | 0014-08-RMC |
| Study First Received: | July 30, 2008 |
| Last Updated: | February 15, 2009 |
| Health Authority: | Israel: Ethics Commission |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Sarcoma, Endometrial Stromal Uterine Cervical Neoplasms Ovarian Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases Genital Diseases, Female |
Neoplasms, Complex and Mixed Neoplasms by Histologic Type Sarcoma Neoplasms, Connective and Soft Tissue Endometrial Stromal Tumors Uterine Cervical Diseases Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Endocrine System Diseases Gonadal Disorders |
ClinicalTrials.gov processed this record on May 19, 2013