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

March 6, 2019 updated by: Lari Wenzel, University of California, Irvine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92697
        • UCI, Health Policy and Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in quality of life measured by FACT-Cx
Time Frame: Baseline and 4 months after enrollment
FACT-Cx (Functional Assessment of Cancer Therapy-Cervical)
Baseline and 4 months after enrollment
Change in neuroendocrine parameters
Time Frame: Baseline and 4 months after enrollment
Saliva samples were tested for cortisol
Baseline and 4 months after enrollment
Change in neuroendocrine parameters
Time Frame: Baseline and 4 months after enrollment
Saliva samples were tested for dehydroepiandrosterone (DHEA) to calculate cortisol/DHEA ratios
Baseline and 4 months after enrollment
Change in immune parameters
Time Frame: 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
Baseline and 4 months after enrollment
Change in immune parameters
Time Frame: Baseline and 4 months after enrollment
Blood samples were tested for counterregulatory cytokine IL-10
Baseline and 4 months after enrollment
Correlation of psychosocial measures and immunologic stance
Time Frame: 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
Baseline and 4 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Lari B. Wenzel, PhD, Chao Family Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2004

Primary Completion (Actual)

December 31, 2005

Study Completion (Actual)

June 30, 2007

Study Registration Dates

First Submitted

June 28, 2004

First Submitted That Met QC Criteria

June 28, 2004

First Posted (Estimate)

June 29, 2004

Study Record Updates

Last Update Posted (Actual)

March 8, 2019

Last Update Submitted That Met QC Criteria

March 6, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCIRVINE-2003-3030
  • CDR0000510143 (Registry Identifier: PDQ (Physician Data Query))
  • R21CA098794 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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