NCT01043003

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

Support for Hispanic Breast Cancer Patients and Caregivers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• 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

Interventions

Type	Name	Description
OTHER	educational intervention	Undergo Bilingual Breast Cancer Educational Intervention
PROCEDURE	quality-of-life assessment	Ancillary studies
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

Timeline

• Start date: 2006-08-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2010-01-06
• Last updated: 2015-06-08

Locations

1 site across 1 country: United States