Status:
COMPLETED
Telephone Counseling or Standard Care in Patients Who Have Completed Treatment for Stages I, II, or III Cervical Cancer
Lead Sponsor:
University of California, Irvine
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cervical Cancer
Psychosocial Effects of Cancer and Its Treatment
Eligibility:
FEMALE
18-120 years
Phase:
NA
Brief 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 chan...
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 ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- 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
- 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
- EXCLUSION CRITERIA
- 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
- Any acute or chronic illness, including autoimmune states, as judged clinically significant by the investigators
- Patient Characteristics:
- Non-English or Spanish speakers
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2007
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00086242
Start Date
August 1 2004
End Date
June 30 2007
Last Update
March 8 2019
Active Locations (1)
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1
UCI, Health Policy and Research Center
Irvine, California, United States, 92697