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

Sponsor

University of California, Irvine (Other)

Overall Status

Completed

CT.gov ID

NCT00086242

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arms

34.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer Psychosocial Effects of Cancer and Its Treatment	Behavioral: Psychosocial Telephone Counseling (PTC)	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Stress-Immune Response and Cervical Cancer

Actual Study Start Date :

Aug 1, 2004

Actual Primary Completion Date :

Dec 31, 2005

Actual Study Completion Date :

Jun 30, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Psychosocial 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.	Behavioral: Psychosocial 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.
No Intervention: Usual Care 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.

Arm

Intervention/Treatment

Experimental: Psychosocial 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.

Behavioral: Psychosocial Telephone Counseling (PTC)

No Intervention: Usual Care

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.

Outcome Measures

Primary Outcome Measures

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 neuroendocrine parameters [Baseline and 4 months after enrollment]
Saliva samples were tested for dehydroepiandrosterone (DHEA) to calculate cortisol/DHEA ratios
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
Change in immune parameters [Baseline and 4 months after enrollment]
Blood samples were tested for counterregulatory cytokine IL-10
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

Female

Accepts 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