Survivorship Booklets With or Without Individual Telephone Sessions in Increasing Knowledge About the Impact of Breast Cancer in African American and Latina Breast 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:	NCT00932997

Purpose

RATIONALE: Telephone sessions and survivorship booklets may increase knowledge about the psychological and physical impact of breast cancer and increase awareness of available resources. It is not yet known whether survivorship booklets are more effective when given alone or together with individual telephone sessions in informing breast cancer survivors.

PURPOSE: This randomized clinical trial is studying individual telephone sessions given together with survivorship booklets compared with survivorship booklets alone to see how well they work in increasing knowledge about the impact of breast cancer in African American and Latina breast cancer survivors.

Condition	Intervention
Breast Cancer Cancer Survivor Psychosocial Effects of Cancer and Its Treatment	Behavioral: telephone-based intervention Other: counseling intervention Other: educational intervention Other: questionnaire administration Procedure: psychosocial assessment and care Procedure: quality-of-life assessment

Study Type:	Interventional
Study Design:	Randomized, Active Control
Official Title:	Reducing the Burden of Breast Cancer Among African American and Latina Survivors

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

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

Primary Outcome Measures:

Increased knowledge about the psychological and physical impact of breast cancer [ Designated as safety issue: No ]
Improved psychological functioning (depression and anxiety) [ Designated as safety issue: No ]
Improved family and social functioning (changes in family and partner communications) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Predictors of health-related quality of life (demographic, medical care factors, psychological, socio-ecological, and socio-cultural factors) [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	October 2006
Estimated Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Evaluate the utility of individual telephone sessions plus survivorship booklets versus the survivorship booklets alone in increasing knowledge about the psychological and physical impact of breast cancer and increasing awareness of appropriate psychological and medical resources among African American and Latina breast cancer survivors.
Evaluate the utility of these interventions in improving psychological functioning (depression and anxiety) among breast cancer survivors.
Evaluate the utility of these interventions in improving family and social functioning (changes in family and partner communications) among breast cancer survivors.

Secondary

Evaluate predictors of health-related quality of life (demographic, medical care factors, psychological, socio-ecological, and socio-cultural factors) within and across breast cancer survivors ethnic groups to identify both general and ethnic-specific correlates.

OUTLINE: Patients are stratified according to ethnicity (African American vs Latina). Patients are randomized to

1 of 2 groups.

Group 1: Patients receive a survivorship kit of booklets in English or Spanish. Patients then receive a follow-up telephone call at approximately 2 months to clarify any issues relevant to the survivorship kit of booklets.
Group 2: Patients participate in 8 weekly telephone sessions addressing basic breast cancer information; education about psychological and medical effects of cancer and its treatments; resources including psychosocial, medical care facilities, and clinical trials information; stress management and relaxation; cognitive reframing of concerns and behavioral strategies; family communication; relational communication and intimacy; and social support. Patients also receive a survivorship kit of booklets as in group 1. After completion of study intervention, patients complete follow-up questionnaires at 4 to 6 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosed with breast cancer within the past 1-5 years
- Stage I-IIIA disease
No metastatic disease

PATIENT CHARACTERISTICS:

No other major disabling medical (e.g., another cancer, stroke, heart disease) or psychiatric conditions
Self-identified ethnically as African-American or Latina
Able to read and/or speak English or Spanish
No severe depression or anxiety
- History of mild to moderate depression or anxiety allowed
Not pregnant
Not incarcerated

PRIOR CONCURRENT THERAPY:

Any type of prior anticancer therapy allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932997

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:	CDR0000642414, CHNMC-06102
Study First Received:	July 3, 2009
Last Updated:	July 22, 2009
ClinicalTrials.gov Identifier:	NCT00932997 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

psychosocial effects of cancer and its treatment
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
cancer survivor

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on September 10, 2009