Cervical CancerNCT00086242
Telephone Counseling or Standard Care in Patients Who Have Completed Treatment for Stages I, II, or III Cervical Cancer
A study testing Psychosocial Telephone Counseling (PTC) in people with Cervical Cancer and Psychosocial Effects of Cancer and Its Treatment, run by University of California, Irvine at 1 site in United States.
Trial summary
RATIONALE: Telephone counseling after treatment may reduce stress and improve the well-being and quality of life of patients who have cervical cancer. Changes in quality of life may be related to changes in immune function and neuroendocrine function. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Cervical Cancer, Psychosocial Effects of Cancer and Its Treatment
- What is being tested?
- Psychosocial Telephone Counseling (PTC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2004to 30 Jun 2007
- Phase
- Interventional
- 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 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Disease Characteristics:
- Diagnosis of cervical cancer between the past 3-15 months
- Stage I-III disease
- Completed therapy for cervical cancer ≥ 1 month ago
- Not receiving ongoing treatment
- More than 4 weeks since prior immunotherapy
Show all 15Show fewer
- More than 30 days since prior investigational drugs
- No prior biological response modifier
- No concurrent corticosteroids
- No concurrent immunosuppressive therapy
- Patient Characteristics:
- Resident of Orange, San Diego, or Imperial County in California
- English or Spanish speaking
- No serious acute or chronic illness
- Has access to a telephone
Who cannot join
- Disease Characteristics:
- Stage IV cervical carcinoma
- Have undergone previous treatment with a biological response modifier (inferferons, interleukins) or prior immunotherapy within four weeks of study enrollment
- Used investigational drugs within 30 days of execution of the informed consent
- Required corticosteroids or were under immune suppression for any reason including an organ allograft or HIV infection
- Patients with metastatic disease or ongoing treatment
Show all 9Show fewer
- Any acute or chronic illness, including autoimmune states, as judged clinically significant by the investigators
- Patient Characteristics:
- Non-English or Spanish speakers
Trial locations and contacts
1 site in 1 country.
United States1 site
UCI, Health Policy and Research Center
Irvine, California, 92697
About this study
Official title: Stress-Immune Response and Cervical Cancer
RATIONALE: Telephone counseling after treatment may reduce stress and improve the well-being and quality of life of patients who have cervical cancer. Changes in quality of life may be related to changes in immune function and neuroendocrine function.
PURPOSE: This randomized phase I trial is studying how well telephone counseling works compared to standard care in reducing stress in patients who have completed treatment for stage I, stage II, or stage III cervical cancer.
Read the detailed description
OBJECTIVES:
- Compare quality of life (QOL) at baseline and changes in QOL, immune response, and neuroendocrine parameters over time in patients who have completed treatment for stage I-III cervical cancer receiving psychosocial telephone counseling vs usual care.
- Correlate psychosocial measures with immunologic stance.
OUTLINE: This is a randomized, controlled, parallel-group study. Patients are randomized to 1 of 2 intervention arms.
- Arm I: Patients undergo psychosocial telephone counseling comprising 5 weekly sessions and a 1-month follow-up session to learn strategies for reducing stress.
- Arm II: Patients undergo usual care for approximately 4 months. All patients complete questionnaires and Quality of life assessment at baseline and at 4 months. They also undergo saliva and blood sample collections at baseline and at 4 months for neuroimmune studies.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
- Being tested
- Psychosocial Telephone Counseling (PTC)
- Keywords
- psychosocial effects of cancer and its treatment, stage IA cervical cancer, stage IB cervical cancer, stage IIA cervical cancer, stage IIB cervical cancer, stage III cervical cancer
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial Telephone Counseling (PTC)Behavioural
Eligible patients are randomized to receive psychosocial telephone counseling (PTC) or usual care.The PTC intervention was specifically designed to help women cope with the stressful events and feelings of distress associated with cervical cancer. The PTC arm of the study received six counseling sessions, ~45 to 50 min in length, in their preferred language, consisting of five consecutive weekly sessions and a 1-month booster session, delivered by a psychologist. A review letter, generated by the counselor after each session, recapitulated the session's contents and reinforced adaptive coping strategies.
| Study group | Role | What they receive |
|---|---|---|
| Psychosocial Telephone Counseling (PTC) | Experimental | Eligible patients are randomized to receive psychosocial telephone counseling (PTC) or usual care.The PTC intervention was specifically designed to help women cope with the stressful events and feelings of distress associated with cervical cancer. The PTC arm of the study received six counseling sessions, ~45 to 50 min in length, in their preferred language, consisting of five consecutive weekly sessions and a 1-month booster session, delivered by a psychologist. A review letter, generated by the counselor after each session, recapitulated the session's contents and reinforced adaptive coping strategies. Receives: Behavioral: Psychosocial Telephone Counseling (PTC) |
| Usual Care | No intervention | Eligible patients are randomized to receive either psychosocial telephone counseling (PTC) or usual care. The usual care are were only contacted by the study team to collect data in an identical frame to subjects receiving PTC. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life measured by FACT-Cx
FACT-Cx (Functional Assessment of Cancer Therapy-Cervical)
Measured: Baseline and 4 months after enrollment
Change in neuroendocrine parameters
Saliva samples were tested for cortisol
Measured: Baseline and 4 months after enrollment
Change in neuroendocrine parameters
Saliva samples were tested for dehydroepiandrosterone (DHEA) to calculate cortisol/DHEA ratios
Measured: Baseline and 4 months after enrollment
Change in immune parameters
Blood samples were tested for T helper type 1and 2 (Th1/Th2) bias, as measured by IFN-γ/interleukin-5 ELISpot T
Measured: Baseline and 4 months after enrollment
Change in immune parameters
Blood samples were tested for counterregulatory cytokine IL-10
Measured: Baseline and 4 months after enrollment
Correlation of psychosocial measures and immunologic stance
Spearman's correlation coefficient between the change in FACT-Cx and the change in Th1/Th2 Immune system bias
Measured: Baseline and 4 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2004 (estimated)
- Study start1 Aug 2004
- Primary completion31 Dec 2005
- Study completion30 Jun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Lari Wenzel, University of California, Irvine
- Investigators
- Lari B. Wenzel, PhD, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00086242
- Sponsor's protocol ID
- UCIRVINE-2003-3030
- Other IDs
- CDR0000510143, R21CA098794
- Status last verified
- Mar 2019
- First submitted
- 28 Jun 2004
- Last updated
- 8 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress-Immune Response and Cervical Cancer
- ClinicalTrials.gov ID
- NCT00086242
- Acronym / sponsor ID
- UCIRVINE-2003-3030
- Keywords
- psychosocial effects of cancer and its treatment, stage IA cervical cancer, stage IB cervical cancer, stage IIA cervical cancer, stage IIB cervical cancer, stage III cervical cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Aug 2004 (actual)
- Primary completion
- 31 Dec 2005 (actual)
- Study completion
- 30 Jun 2007 (actual)
- First posted
- 29 Jun 2004 (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.
RATIONALE: Telephone counseling after treatment may reduce stress and improve the well-being and quality of life of patients who have cervical cancer. Changes in quality of life may be related to changes in immune function and neuroendocrine function.
PURPOSE: This randomized phase I trial is studying how well telephone counseling works compared to standard care in reducing stress in patients who have completed treatment for stage I, stage II, or stage III cervical cancer.
Detailed description
OBJECTIVES:
- Compare quality of life (QOL) at baseline and changes in QOL, immune response, and neuroendocrine parameters over time in patients who have completed treatment for stage I-III cervical cancer receiving psychosocial telephone counseling vs usual care.
- Correlate psychosocial measures with immunologic stance.
OUTLINE: This is a randomized, controlled, parallel-group study. Patients are randomized to 1 of 2 intervention arms.
- Arm I: Patients undergo psychosocial telephone counseling comprising 5 weekly sessions and a 1-month follow-up session to learn strategies for reducing stress.
- Arm II: Patients undergo usual care for approximately 4 months. All patients complete questionnaires and Quality of life assessment at baseline and at 4 months. They also undergo saliva and blood sample collections at baseline and at 4 months for neuroimmune studies.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychosocial Telephone Counseling (PTC) | Experimental | Behavioral: Psychosocial Telephone Counseling (PTC)Eligible patients are randomized to receive psychosocial telephone counseling (PTC) or usual care.The PTC intervention was specifically designed to help women cope with the stressful events and feelings of distress associated with cervical cancer. The PTC arm of the study received six counseling sessions, ~45 to 50 min in length, in their preferred language, consisting of five consecutive weekly sessions and a 1-month booster session, delivered by a psychologist. A review letter, generated by the counselor after each session, recapitulated the session's contents and reinforced adaptive coping strategies. |
| Usual Care | No intervention | –Eligible patients are randomized to receive either psychosocial telephone counseling (PTC) or usual care. The usual care are were only contacted by the study team to collect data in an identical frame to subjects receiving PTC. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Diagnosis of cervical cancer between the past 3-15 months
- Completed therapy for cervical cancer ≥ 1 month ago
- More than 4 weeks since prior immunotherapy
- More than 30 days since prior investigational drugs
- No prior biological response modifier
Key exclusion criteria (9 listed)
- Stage IV cervical carcinoma
- Have undergone previous treatment with a biological response modifier (inferferons, interleukins) or prior immunotherapy within four weeks of study enrollment
- Used investigational drugs within 30 days of execution of the informed consent
- Required corticosteroids or were under immune suppression for any reason including an organ allograft or HIV infection
- Patients with metastatic disease or ongoing treatment
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 |
|---|---|---|
| Psychosocial Telephone Counseling (PTC)Eligible patients are randomized to receive psychosocial telephone counseling (PTC) or usual care.The PTC intervention was specifically designed to help women cope with the stressful events and feelings of distress associated with cervical cancer. The PTC arm of the study received six counseling sessions, ~45 to 50 min in length, in their preferred language, consisting of five consecutive weekly sessions and a 1-month booster session, delivered by a psychologist. A review letter, generated by the counselor after each session, recapitulated the session's contents and reinforced adaptive coping strategies. | Behavioural | Psychosocial Telephone Counseling (PTC) |
Primary outcome
Change in quality of life measured by FACT-Cx
Time frame: Baseline and 4 months after enrollment
FACT-Cx (Functional Assessment of Cancer Therapy-Cervical)
Change in neuroendocrine parameters
Time frame: Baseline and 4 months after enrollment
Saliva samples were tested for cortisol
Change in neuroendocrine parameters
Time frame: Baseline and 4 months after enrollment
Saliva samples were tested for dehydroepiandrosterone (DHEA) to calculate cortisol/DHEA ratios
Change in immune parameters
Time frame: Baseline and 4 months after enrollment
Blood samples were tested for T helper type 1and 2 (Th1/Th2) bias, as measured by IFN-γ/interleukin-5 ELISpot T
Change in immune parameters
Time frame: Baseline and 4 months after enrollment
Blood samples were tested for counterregulatory cytokine IL-10
Correlation of psychosocial measures and immunologic stance
Time frame: Baseline and 4 months after enrollment
Spearman's correlation coefficient between the change in FACT-Cx and the change in Th1/Th2 Immune system bias
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
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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.
Lari B. Wenzel, PhD principal investigator
Chao Family Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial Telephone Counseling (PTC) in people with Cervical Cancer and Psychosocial Effects of Cancer and Its Treatment, run by University of California, Irvine at 1 site in United States.
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 15 inclusion and 9 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: finished, as of the sponsor's last update on 8 Mar 2019. 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 United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life measured by FACT-Cx (time frame: Baseline and 4 months after enrollment). The study lists 6 primary outcomes in all. 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 8 Mar 2019.