Telephone Counseling or Standard Care in Patients Who Have Completed Treatment for Stages I, II, or III Cervical Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cervical Cancer, Cervical Cancer, Cancer, Cancer, Psychiatric, Women's Studies |
| Therapuetic Areas: | Oncology, Psychiatry / Psychology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 3/10/2019 |
| Start Date: | August 1, 2004 |
| End Date: | June 30, 2007 |
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.
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.
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.
- 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.
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
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