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

NCT00086242 | Completed

• 3 other identifiers: UCIRVINE-2003-3030CDR0000510143R21CA098794
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Psychosocial Telephone Counseling (PTC)

EXPERIMENTAL

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)

Usual Care

NO INTERVENTION

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.

Interventions

Psychosocial Telephone Counseling (PTC) 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.

Psychosocial Telephone Counseling (PTC)

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UCI, Health Policy and Research Center

Irvine, California, 92697, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Lari B. Wenzel, PhD

  Chao Family Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 28, 2004
• First Posted: June 29, 2004
• Study Start: August 1, 2004
• Primary Completion: December 31, 2005
• Study Completion: June 30, 2007
• Last Updated: March 8, 2019

Record last verified: 2019-03

Locations

US (1)