Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086242
Status:
COMPLETED
Last Update Posted:
2019-03-08
First Post:
2004-06-28
Brief Title:
Telephone Counseling or Standard Care in Patients Who Have Completed Treatment for Stages I II or III Cervical Cancer
Sponsor:
University of California Irvine
Organization:
University of California Irvine
Study Overview
Official Title:
Stress-Immune Response and Cervical Cancer
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21CA098794 | NIH | PDQ Physician Data Query | httpsreporternihgovquickSearchR21CA098794 |
| CDR0000510143 | REGISTRY | None | None |