Intervention to Promote Uptake of Cancer Risk Counseling for Underserved Latinas
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 493
- 试验地点
- 6
- 主要终点
- Effect of pre-GCRA intervention versus a time and attention control versus standard scheduling procedure alone (usual) on levels of anxiety, perceived personal control and cancer genetic knowledge
研究概览
简要总结
This pilot clinical trial studies a culturally-informed counseling intervention in Latinas at high risk for hereditary breast or ovarian cancer. A culturally-informed counseling intervention may be an effective method to help people learn more about their cancer risk.
详细描述
PRIMARY OBJECTIVES:
I. To conduct a randomized trial of a culturally-informed pre-genetic cancer risk assessment (GCRA) telephone intervention.
II. To evaluate the effect of the pre-GCRA intervention versus a time and attention control versus standard scheduling procedure alone (usual care) on levels of anxiety, perceived personal control and cancer genetics knowledge.
III. To explore patients' experiences with the pre-GCRA intervention through post-intervention telephone interviews.
SECONDARY OBJECTIVES:
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
- •Individuals who have a personal history of hereditary breast or ovarian cancer; a subset of 60 women without a personal history of hereditary or ovarian cancer will be included in an exploratory subset analysis
- •Meet NCCN criteria for consideration of genetic testing for hereditary breast cancer
- •Willing to sign consent
- •Pregnant women and women of child-bearing potential are eligible for participation in this study
- •Women who report themselves to be of Latino or Hispanic ethnic background (defined as Spanish, Mexican, Central or South American, Cuban, Puerto Rican, Dominican, or other Hispanic origin)
- •Women who are under- or uninsured and come from low-income communities
- •Ability to understand English or Spanish
排除标准
- •Previous participation in GCRA
结局指标
主要结局
Effect of pre-GCRA intervention versus a time and attention control versus standard scheduling procedure alone (usual) on levels of anxiety, perceived personal control and cancer genetic knowledge
时间窗: One week after genetic cancer risk assessment (GCRA)
Tested using 3 x 3 repeated measures analysis of covariance (ANCOVA)s in which the within subjects variables are anxiety or perceived control, the between groups variable is group membership, and covariates include fatalism and other appropriate moderators.
Experiences with the pre-GCRA intervention through post-intervention telephone interviews
时间窗: One week after genetic cancer risk assessment (GCRA)
Conduct a randomized controlled trial of a culturally-informed pre-GCRA telephone intervention utilizing AMI techniques
时间窗: One week after genetic cancer risk assessment (GCRA)
Will use a multivariate ANCOVA (MANCOVA) to test for group differences among all five preparedness scores, with step-down F ratios of each individual score, using fatalism and other moderators as covariates, as appropriate.
次要结局
- Perceived barriers to GCRA through no-show telephone interviews(One week after genetic cancer risk assessment (GCRA))