The Assessment of Preoperative Psychological Intervention on Stress in Women With Gynecological Malignancies
Assessment of the Impact of Preoperative Stress Reduction on Psychological, Physiological and Immunological Parameters in Women With Gynecological Malignancies - Prospective Randomized Controlled Trial
1 other identifier
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2008
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2008
CompletedFirst Posted
Study publicly available on registry
August 1, 2008
CompletedStudy Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedFebruary 17, 2009
July 1, 2008
1 year
July 30, 2008
February 15, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
psychological, physiological, immunological parameters
A week before surgery, the day befor surgery, day of hospital discharge, one month after surgery
Study Arms (3)
1
ACTIVE COMPARATORWomen in this arm will not receive a psychological intervention but rather will have a conversation with a nurse for one hour (attention control).
2
EXPERIMENTALCognitive intervention: Women in this arm will receive a cognitive psychological intervention(cognitive technique:self-talk)
3
EXPERIMENTALPsycho-physiological intervention: Women in this arm will receive a psycho-physiological intervention (relaxation and guided imagery)
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- Woman with ovarian, cervical or endometrial cancer/tumor
- Women who speak Hebrew
- Women who sign the consent form
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rabin Medical Centerlead
- Academic College of Tel Aviv-Jaffacollaborator
- Israel Cancer Associationcollaborator
Study Sites (1)
Rabin Medical center
Petah Tikva, 49100, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Opher Caspi, MD PhD
Director, Integrative Medicine - Rabin Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 30, 2008
First Posted
August 1, 2008
Study Start
August 1, 2008
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
February 17, 2009
Record last verified: 2008-07