Support for Hispanic Breast Cancer Patients and Caregivers
| Registry | NCT01043003 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, supportive care |
| Enrollment | 49 (Actual) |
| Sponsor | City of Hope Medical Center (Other) |
| 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 | educational intervention, quality-of-life assessment, Questionnaire Administration, psychosocial support for caregiver, assessment of therapy complications, informational intervention (Other, procedure) |
| Dates | start 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 in United States |
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All trials for Breast Cancer All trials for Ductal Breast Carcinoma in Situ All trials of educational intervention All trials of quality-of-life assessment
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Arm I | Experimental | Other: educational intervention; Procedure: quality-of-life assessment; Other: Questionnaire Administration; Other: psychosocial support for caregiver; Procedure: assessment of therapy complications; Other: informational intervention | 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. |
| Arm II | Active comparator | Procedure: quality-of-life assessment; Other: Questionnaire Administration; Other: psychosocial support for caregiver; Procedure: assessment of therapy complications; Other: informational intervention | 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. |
Sex: Female, ages: 18 Years to any, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| City of Hope | Duarte, California | United States |