The Assessment of Preoperative Psychological Intervention on Stress in Women With Gynecological Malignancies

Clalit Health Services

Status and phase: Unknown; Phase 3

Conditions: Cancer of Endometrium; Cancer of Cervix; Ovarian Cancer

Treatments: Other: psycho-physiological intervention; Other: Control group; Behavioral: Cognitive intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT00726635

0014-08-RMC

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

1

Active Comparator group

Description:

Women in this arm will not receive a psychological intervention but rather will have a conversation with a nurse for one hour (attention control).

Treatment:

Other: Control group

2

Experimental group

Description:

Cognitive intervention: Women in this arm will receive a cognitive psychological intervention(cognitive technique:self-talk)

Treatment:

Behavioral: Cognitive intervention

3

Experimental group

Description:

Psycho-physiological intervention: Women in this arm will receive a psycho-physiological intervention (relaxation and guided imagery)

Treatment:

Other: psycho-physiological intervention