Cervical Cancer, Psychosocial Effects of Cancer and Its Treatment
Conditions
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
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 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.
Interventions
BEHAVIORALPsychosocial 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.
Sponsors
National Cancer Institute (NCI)
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life measured by FACT-Cx | Baseline and 4 months after enrollment | FACT-Cx (Functional Assessment of Cancer Therapy-Cervical) |
| Change in neuroendocrine parameters | Baseline and 4 months after enrollment | Saliva samples were tested for cortisol |
| Change in immune parameters | 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 |
| Correlation of psychosocial measures and immunologic stance | 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 |
Countries
United States
Outcome results
None listed