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

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: Cervical Cancer; Psychosocial Effects of Cancer and Its Treatment
• Intervention / Treatment: Behavioral: Psychosocial Telephone Counseling (PTC)

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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

Collaborators and Investigators

• 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

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: psychosocial effects of cancer and its treatment; stage IIB cervical cancer; stage III cervical cancer; stage IB cervical cancer; stage IIA cervical cancer; stage IA cervical cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• 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