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Telephone Counseling or Standard Care in Patients Who Have Completed Treatment for Stages I, II, or III Cervical Cancer

Primary Purpose

Cervical Cancer, Psychosocial Effects of Cancer and Its Treatment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychosocial Telephone Counseling (PTC)
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cervical Cancer focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • UCI, Health Policy and Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Psychosocial Telephone Counseling (PTC)

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in quality of life measured by FACT-Cx
FACT-Cx (Functional Assessment of Cancer Therapy-Cervical)
Change in neuroendocrine parameters
Saliva samples were tested for cortisol
Change in neuroendocrine parameters
Saliva samples were tested for dehydroepiandrosterone (DHEA) to calculate cortisol/DHEA ratios
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
Change in immune parameters
Blood samples were tested for counterregulatory cytokine IL-10
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

Secondary Outcome Measures

Full Information

First Posted
June 28, 2004
Last Updated
March 6, 2019
Sponsor
University of California, Irvine
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00086242
Brief Title
Telephone Counseling or Standard Care in Patients Who Have Completed Treatment for Stages I, II, or III Cervical Cancer
Official Title
Stress-Immune Response and Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2004 (Actual)
Primary Completion Date
December 31, 2005 (Actual)
Study Completion Date
June 30, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Psychosocial Effects of Cancer and Its Treatment
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psychosocial Telephone Counseling (PTC)
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychosocial Telephone Counseling (PTC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in quality of life measured by FACT-Cx
Description
FACT-Cx (Functional Assessment of Cancer Therapy-Cervical)
Time Frame
Baseline and 4 months after enrollment
Title
Change in neuroendocrine parameters
Description
Saliva samples were tested for cortisol
Time Frame
Baseline and 4 months after enrollment
Title
Change in neuroendocrine parameters
Description
Saliva samples were tested for dehydroepiandrosterone (DHEA) to calculate cortisol/DHEA ratios
Time Frame
Baseline and 4 months after enrollment
Title
Change in immune parameters
Description
Blood samples were tested for T helper type 1and 2 (Th1/Th2) bias, as measured by IFN-γ/interleukin-5 ELISpot T
Time Frame
Baseline and 4 months after enrollment
Title
Change in immune parameters
Description
Blood samples were tested for counterregulatory cytokine IL-10
Time Frame
Baseline and 4 months after enrollment
Title
Correlation of psychosocial measures and immunologic stance
Description
Spearman's correlation coefficient between the change in FACT-Cx and the change in Th1/Th2 Immune system bias
Time Frame
Baseline and 4 months after enrollment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lari B. Wenzel, PhD
Organizational Affiliation
Chao Family Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCI, Health Policy and Research Center
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Telephone Counseling or Standard Care in Patients Who Have Completed Treatment for Stages I, II, or III Cervical Cancer

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