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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Support for Hispanic Breast Cancer Patients and Caregivers

Conditions
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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

Intervention / Treatment
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* Other: educational intervention
* Procedure: quality-of-life assessment
* Other: Questionnaire Administration
* Other: psychosocial support for caregiver
* Procedure: assessment of therapy complications
* Other: informational intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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<br>* Undergo Bilingual Breast Cancer Educational Intervention<br>* Other names: intervention, educational;Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: psychosocial support for caregiver<br>* Support for caregiver<br>Procedure: assessment of therapy complications<br>* Ancillary study<br>Other: informational intervention<br>* Undergo evaluation sessions<br>|
| Active Comparator: Arm II<br>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<br>* Ancillary studies<br>* Other names: quality of life assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: psychosocial support for caregiver<br>* Support for caregiver<br>Procedure: assessment of therapy complications<br>* Ancillary study<br>Other: informational intervention<br>* Undergo evaluation sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | At 1, 3, and 6 months post intervention | 
| Effect of influencing demographic and treatment variables on outcomes of the BBCEI |  | At 1, 3, and 6 months post intervention | 
| Perceived quality of the BBCEI |  | At 1, 3, and 6 months post intervention |