Clinical trial · Interventional
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
NCT01043003CI-TRIAL-00018196completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Ductal Breast Carcinoma in Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
| Stage I Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| assessment of therapy complications | Procedure | — | UNRESOLVED |
| educational intervention | Other | — | UNRESOLVED |
| informational intervention | Other | — | UNRESOLVED |
| psychosocial support for caregiver | Other | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- 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.
- interventionNames
- Other: educational intervention
- Procedure: quality-of-life assessment
- Other: Questionnaire Administration
- Other: psychosocial support for caregiver
- Procedure: assessment of therapy complications
- Other: informational intervention
- type
- ACTIVE_COMPARATOR
- label
- Arm II
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.