Breast Cancer Clinical Trial
Official title:
Support for Hispanic Breast Cancer Patients and Caregivers
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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