Cancer of CervixPhase 3NCT00726635
The Assessment of Preoperative Psychological Intervention on Stress in Women With Gynecological Malignancies
A Phase 3 study testing Cognitive intervention and psycho-physiological intervention in people with Cancer of Cervix and Ovarian Cancer, run by Rabin Medical Center at 1 site in Israel.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cancer of Cervix, Ovarian Cancer, Cancer of Endometrium
- What is being tested?
- Cognitive intervention and psycho-physiological intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2008to Aug 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman with ovarian, cervical or endometrial cancer/tumor
- Women who speak Hebrew
- Women who sign the consent form
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical center
Petah Tikva, 49100
Opher Caspi, MD PhD, 972-3937795, ocaspi@clalit.org.il
Mira Livingstone, B.A, 972-542562083, mira.livingstone@gmail.com
About this 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
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
Read the 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.
- Conditions
- Cancer of Cervix, Ovarian Cancer, Cancer of Endometrium
- Being tested
- Cognitive intervention, Control group, psycho-physiological intervention
- Medical subject headings
- Uterine Cervical Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive interventionBehavioural
Also called Tailored 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.
Control groupOther
A one hour conversation with a nurse
psycho-physiological interventionOther
Also called tailored 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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Control group |
| 2 | Experimental | Cognitive intervention: Women in this arm will receive a cognitive psychological intervention(cognitive technique:self-talk) Receives: Behavioral: Cognitive intervention |
| 3 | Experimental | Psycho-physiological intervention: Women in this arm will receive a psycho-physiological intervention (relaxation and guided imagery) Receives: Other: psycho-physiological intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
psychological, physiological, immunological parameters
Measured: A week before surgery, the day befor surgery, day of hospital discharge, one month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionAug 2009 (estimated)
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of CervixStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Academic College of Tel Aviv-Jaffa, Israel Cancer Association
- Investigators
- Opher Caspi, MD PhD, Principal investigator, Director, Integrative Medicine - Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726635
- Sponsor's protocol ID
- 0014-08-RMC
- Status last verified
- Jul 2008
- First submitted
- 30 Jul 2008
- Last updated
- 17 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00726635
- Acronym / sponsor ID
- 0014-08-RMC
- Conditions
- Cancer of Cervix, Ovarian Cancer, Cancer of Endometrium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Academic College of Tel Aviv-Jaffa, Israel Cancer Association
- Study start
- Aug 2008
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Aug 2009 (estimated)
- First posted
- 1 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Control groupWomen in this arm will not receive a psychological intervention but rather will have a conversation with a nurse for one hour (attention control). |
| 2 | Experimental | Behavioral: Cognitive interventionCognitive intervention: Women in this arm will receive a cognitive psychological intervention(cognitive technique:self-talk) |
| 3 | Experimental | Other: psycho-physiological interventionPsycho-physiological intervention: Women in this arm will receive a psycho-physiological intervention (relaxation and guided imagery) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Woman with ovarian, cervical or endometrial cancer/tumor
- Women who speak Hebrew
- Women who sign the consent form
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive interventionAlso: Tailored cognitive interventionThe 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. | Behavioural | 2 |
| Control groupA one hour conversation with a nurse | Other | 1 |
| psycho-physiological interventionAlso: tailored psycho-physiological interventionThe 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 | 3 |
Primary outcome
psychological, physiological, immunological parameters
Time frame: A week before surgery, the day befor surgery, day of hospital discharge, one month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Opher Caspi, MD PhD principal investigator
Director, Integrative Medicine - Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cognitive intervention and psycho-physiological intervention in people with Cancer of Cervix and Ovarian Cancer, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Opher Caspi, MD PhD (972-39377995, ocaspi@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
psychological, physiological, immunological parameters (time frame: A week before surgery, the day befor surgery, day of hospital discharge, one month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2009.