Support for Hispanic Breast Cancer Patients and Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Perceived quality of the BBCEI
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
- •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
排除标准
- 未提供
研究组 & 干预措施
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. Patients and caregivers receive reinforcement telephone calls every other week.
干预措施: Questionnaire Administration (Other)
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. Patients and caregivers receive reinforcement telephone calls every other week.
干预措施: psychosocial support for caregiver (Other)
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. Patients and caregivers receive reinforcement telephone calls every other week.
干预措施: assessment of therapy complications (Procedure)
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. Patients and caregivers receive reinforcement telephone calls every other week.
干预措施: informational intervention (Other)
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. Patients and caregivers receive reinforcement telephone calls every other week.
干预措施: quality-of-life assessment (Procedure)
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. Patients and caregivers receive reinforcement telephone calls every other week.
干预措施: Questionnaire Administration (Other)
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. Patients and caregivers receive reinforcement telephone calls every other week.
干预措施: psychosocial support for caregiver (Other)
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. Patients and caregivers receive reinforcement telephone calls every other week.
干预措施: assessment of therapy complications (Procedure)
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. Patients and caregivers receive reinforcement telephone calls every other week.
干预措施: informational intervention (Other)
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. Patients and caregivers receive reinforcement telephone calls every other week.
干预措施: educational intervention (Other)
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. Patients and caregivers receive reinforcement telephone calls every other week.
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Perceived quality of the BBCEI
时间窗: At 1, 3, and 6 months post intervention
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
时间窗: At 1, 3, and 6 months post intervention
Effect of influencing demographic and treatment variables on outcomes of the BBCEI
时间窗: At 1, 3, and 6 months post intervention
次要结局
未报告次要终点