Psychosocial Support for African-American, Latina-American, or European-American Cervical Cancer Survivors - Full Text View

Sponsors and Collaborators:	Beckman Research Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00915889

Purpose

RATIONALE: Telephone counseling may help reduce depression and anxiety and improve the well-being and quality of life of cervical cancer survivors.

PURPOSE: This randomized clinical trial is studying how well psychosocial support works in African-American, Latina-American, or European-American cervical cancer survivors.

Condition	Intervention
Cancer Survivor Cervical Cancer Psychosocial Effects of Cancer and Its Treatment	Behavioral: telephone-based intervention Other: counseling intervention Other: questionnaire administration Other: study of socioeconomic and demographic variables Procedure: psychosocial assessment and care

Study Type:	Interventional
Study Design:	Randomized, Active Control
Official Title:	Cervical Cancer Survivorship Among African American and Latina Survivors

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Cancer Depression

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Utility of a psychosocial intervention in educating and improving awareness of the physical and psychological impact of cancer and in increasing knowledge about appropriate medical and psychosocial resources for cervical cancer survivors [ Designated as safety issue: No ]
Utility of a psychosocial intervention in improving psychological functioning (i.e., decreasing depression and anxiety) among cervical cancer survivors [ Designated as safety issue: No ]
Utility of a psychosocial intervention in improving social functioning (i.e., family support and communication) among cervical cancer survivors [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	November 2006
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Evaluate the utility of 6 telephone sessions, 8 telephone sessions, and a survivorship booklet in educating and improving awareness of the physical and psychological impact of cancer and in increasing knowledge about appropriate medical and psychosocial resources for African-American and Latina-American cervical cancer survivors.
Evaluate the utility of these telephone sessions in improving psychological functioning (i.e., decreasing depression and anxiety) among these cervical cancer survivors.
Evaluate the utility of these telephone sessions in improving social functioning (i.e., family support and communication) among these cervical cancer survivors.

OUTLINE: Patients are clinically assigned to 1 of 2 groups according to their response to a baseline questionnaire.

Group I: Patients receive a survivorship booklet in the mail that contains information about cervical cancer.

Patients then receive a follow-up telephone call at 3 months to clarify any issues relevant to the survivorship booklet.

Group II: Patients are randomly assigned to receive either 6 or 8 weekly telephone sessions that address managing medical issues, health education, and cancer resources; balancing emotions and managing stress; coping skills and problem solving; family and social concerns; relational, intimacy, and sexual concerns; and financial and employment concerns. Patients also receive a survivorship booklet as in group I.

Patients in both groups complete questionnaires at 6 and 12 months.

PROJECTED ACCRUAL: A total of 500 patients (150 African-Americans, 200 Latina-Americans, and 150 European-Americans) will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of invasive cervical cancer 6 months to 3 years ago
- Stage I-III disease
African-American, Latina-American, or European-American descent
No other cancer diagnosis
No cervical cancer in situ (stage 0) or cervical intraepithelial neoplasia 2 or 3
No metastatic disease

PATIENT CHARACTERISTICS:

Able to read and/or speak English or Spanish
No other major disabling medical or psychiatric condition
No other major medical condition (e.g., stroke or degenerative illness)
No moderate or severe depression or anxiety
- History of mild depression or anxiety allowed

PRIOR CONCURRENT THERAPY:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915889

Locations

United States, California
City of Hope Comprehensive Cancer Center	Recruiting
Duarte, California, United States, 91010-3000
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org

Sponsors and Collaborators

Beckman Research Institute

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Kimlin Ashing-Giwa, PhD

Beckman Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	City of Hope Comprehensive Cancer Center ( Kimlin Ashing-Giwa )
Study ID Numbers:	CDR0000642406, CHNMC-06081
Study First Received:	June 5, 2009
Last Updated:	July 14, 2009
ClinicalTrials.gov Identifier:	NCT00915889 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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
cancer survivor

ClinicalTrials.gov processed this record on September 03, 2009