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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000510143 | Registry Identifier | PDQ (Physician Data Query) | |
| R21CA098794 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
OUTLINE: This is a randomized, controlled, parallel-group study. Patients are randomized to 1 of 2 intervention arms.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychosocial Telephone Counseling (PTC) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life measured by FACT-Cx | FACT-Cx (Functional Assessment of Cancer Therapy-Cervical) | Baseline and 4 months after enrollment |
| Change in neuroendocrine parameters | Saliva samples were tested for cortisol | Baseline and 4 months after enrollment |
| Change in neuroendocrine parameters | Saliva samples were tested for dehydroepiandrosterone (DHEA) to calculate cortisol/DHEA ratios | 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 | Baseline and 4 months after enrollment |
| Change in immune parameters | Blood samples were tested for counterregulatory cytokine IL-10 | 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 | Baseline and 4 months after enrollment |
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INCLUSION CRITERIA
Disease Characteristics:
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
No concurrent corticosteroids
No concurrent immunosuppressive therapy
Patient Characteristics:
EXCLUSION CRITERIA
Disease Characteristics:
Patient Characteristics:
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| Name | Affiliation | Role |
|---|---|---|
| Lari B. Wenzel, PhD | Chao Family Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCI, Health Policy and Research Center | Irvine | California | 92697 | United States |
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|
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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