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

NCT ID: NCT00086242

Last Updated: 2019-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-01
• Study Completion Date: 2007-06-30

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.

Conditions

Cervical Cancer; Psychosocial Effects of Cancer and Its Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Psychosocial Telephone Counseling (PTC)

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Lari Wenzel

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lari B. Wenzel, PhD

Role: PRINCIPAL_INVESTIGATOR

Chao Family Comprehensive Cancer Center

Locations

UCI, Health Policy and Research Center

Irvine, California, United States

Countries

United States

Other Identifiers

CDR0000510143

Identifier Type: REGISTRY

Identifier Source: secondary_id

R21CA098794

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UCIRVINE-2003-3030

Identifier Type: -

Identifier Source: org_study_id