Bilingual Breast Cancer Educational Intervention for Hispanic Women With Stage I, Stage II, or Stage III Breast Cancer and Their Families or Caregivers - Full Text View

Sponsor:	City of Hope Medical Center
Information provided by (Responsible Party):	City of Hope Medical Center
ClinicalTrials.gov Identifier:	NCT01043003

Purpose

RATIONALE: Studying quality-of-life in patients having cancer treatment may identify the intermediate- and long-term effects of treatment on patients with cancer

PURPOSE: This randomized clinical trial is studying how well an educational intervention works in supporting Hispanic women with stage I, stage II, or stage III breast cancer and their families or caregivers.

Condition	Intervention
Breast Cancer Ductal Breast Carcinoma in Situ Stage I Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer	Other: educational intervention Procedure: quality-of-life assessment Other: Questionnaire Administration Other: psychosocial support for caregiver Procedure: assessment of therapy complications Other: informational intervention

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Support for Hispanic Breast Cancer Patients and Caregivers

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Caregivers

U.S. FDA Resources

Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:

Effects of the Bilingual Breast Cancer Education Intervention on outcomes (physical, psychological, social, spiritual, and overall quality of life) of breast cancer survivor and family caregivers [ Time Frame: At 1, 3, and 6 months post intervention ] [ Designated as safety issue: No ]
Effect of influencing demographic and treatment variables on outcomes of the BBCEI [ Time Frame: At 1, 3, and 6 months post intervention ] [ Designated as safety issue: No ]
Perceived quality of the BBCEI [ Time Frame: At 1, 3, and 6 months post intervention ] [ Designated as safety issue: No ]

Enrollment:	49
Study Start Date:	August 2006
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I Patients and caregivers undergo the Bilingual Breast Cancer Educational Intervention (BBCEI) comprising teaching sessions over 50-65 minutes about 4 specific domains (i.e., physical, psychological, social, and spiritual well being) once weekly during month 1 and also undergo evaluation sessions at months 1, 4, and 7. Patients and caregivers receive reinforcement telephone calls every other week.	Other: educational intervention Undergo Bilingual Breast Cancer Educational Intervention Other Name: intervention, educational Procedure: quality-of-life assessment Ancillary studies Other Name: quality of life assessment Other: Questionnaire Administration Ancillary studies Other: psychosocial support for caregiver Support for caregiver Procedure: assessment of therapy complications Ancillary study Other: informational intervention Undergo evaluation sessions
Active Comparator: Arm II Patients and caregivers undergo usual care comprising evaluation sessions at months 1, 4, and 7. Patients and caregivers may undergo the 4 BBCEI teaching sessions during month 7. Patients and caregivers receive reinforcement telephone calls every other week.	Procedure: quality-of-life assessment Ancillary studies Other Name: quality of life assessment Other: Questionnaire Administration Ancillary studies Other: psychosocial support for caregiver Support for caregiver Procedure: assessment of therapy complications Ancillary study Other: informational intervention Undergo evaluation sessions

Arms

Assigned Interventions

Experimental: Arm I

Patients and caregivers undergo the Bilingual Breast Cancer Educational Intervention (BBCEI) comprising teaching sessions over 50-65 minutes about 4 specific domains (i.e., physical, psychological, social, and spiritual well being) once weekly during month 1 and also undergo evaluation sessions at months 1, 4, and 7. Patients and caregivers receive reinforcement telephone calls every other week.

Other: educational intervention

Undergo Bilingual Breast Cancer Educational Intervention

Other Name: intervention, educational

Procedure: quality-of-life assessment

Ancillary studies

Other Name: quality of life assessment

Other: Questionnaire Administration

Ancillary studies

Other: psychosocial support for caregiver

Support for caregiver

Procedure: assessment of therapy complications

Ancillary study

Other: informational intervention

Undergo evaluation sessions

Active Comparator: Arm II

Patients and caregivers undergo usual care comprising evaluation sessions at months 1, 4, and 7. Patients and caregivers may undergo the 4 BBCEI teaching sessions during month 7. Patients and caregivers receive reinforcement telephone calls every other week.

Procedure: quality-of-life assessment

Ancillary studies

Other Name: quality of life assessment

Other: Questionnaire Administration

Ancillary studies

Other: psychosocial support for caregiver

Support for caregiver

Procedure: assessment of therapy complications

Ancillary study

Other: informational intervention

Undergo evaluation sessions

Detailed Description:

OBJECTIVES:

I. Test the effects of the Bilingual Breast Cancer Education Intervention (BBCEI) on outcomes of breast cancer survivors (BCS) and family caregivers at 1, 3, and 6 months post intervention.

II. Test the effect of influencing demographic and treatment variables on outcomes of the BBCEI at 1, 3, and 6 months post intervention.

III. Examine the perceived quality of the BBCEI.

OUTLINE: Patients and caregivers are randomized to 1 of 2 intervention arms.

ARM I: Patients and caregivers undergo the Bilingual Breast Cancer Educational Intervention (BBCEI) comprising teaching sessions over 50-65 minutes about 4 specific domains (i.e., physical, psychological, social, and spiritual well being) once weekly during month 1 and also undergo evaluation sessions at months 1, 4, and 7.

ARM II: Patients and caregivers undergo usual care comprising evaluation sessions at months 1, 4, and 7. Patients and caregivers may undergo the 4 BBCEI teaching sessions during month 7.

All patients and caregivers receive reinforcement telephone calls every other week.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion

Histologically confirmed diagnosis of stage 0 (DCIS), I, II, or III breast cancer
No evidence of recurrent, metastatic, or second primary cancer
Completing primary treatment with surgery, radiation therapy (if indicated), and/or adjuvant chemotherapy (if indicated)
Subjects may be on hormonal therapy after treatment for initial breast cancer
Self-identification as Hispanic/Latino
Able to read and understand English or Spanish to participate in the patient teaching
Able and willing to participate in the study
The Caregiver selection criteria is: self-identification as the primary caregiver; age 18 years or over; self-identification as Hispanic/Latino; Able to read and speak English or Spanish; Able and willing to participate in the study

Exclusion

Patients will be excluded if they are actively receiving treatment with surgery, radiation therapy, or chemotherapy; patients may be receiving adjuvant hormonal therapy such as Tamoxifen during the course of the study since it is recommended for five years after primary and adjuvant therapy
Patients who have recurrence, metastasis, or a second primary cancer will not be recruited for the study; if however, they develop recurrence, metastasis, or a second primary cancer during the time of the study participation, the subjects will remain in the study
Patients will not be recruited directly from support groups because of potential bias inherent in sample attending support groups; however, some patients may be participating in support groups or other forms of counseling

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01043003

Locations

United States, California
City of Hope
Duarte, California, United States, 91010

Sponsors and Collaborators

City of Hope Medical Center

Investigators

Principal Investigator:

Gloria Juarez

Beckman Research Institute

More Information

No publications provided

Responsible Party:	City of Hope Medical Center
ClinicalTrials.gov Identifier:	NCT01043003 History of Changes
Other Study ID Numbers:	06136, NCI-2009-01548
Study First Received:	January 4, 2010
Last Updated:	January 30, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Breast Neoplasms
Carcinoma
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Neoplasms by Site
Neoplasms

Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Carcinoma, Ductal

ClinicalTrials.gov processed this record on February 09, 2012