Cancer of Cervix, Cancer of Endometrium, Ovarian Cancer
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALCognitive 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.
OTHERControl group
A one hour conversation with a nurse
OTHERpsycho-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
Sponsors
Academic College of Tel Aviv-Jaffa
Israel Cancer Association
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| psychological, physiological, immunological parameters | A week before surgery, the day befor surgery, day of hospital discharge, one month after surgery |
Countries
Israel
Contacts
Primary ContactOpher Caspi, MD PhD
Outcome results
None listed