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临床试验/NCT05138510
NCT05138510已完成不适用

Sexuality and Breast Cancer: Developing Appropriate Education for Women Going Through Treatment

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2020年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
93
试验地点
1
主要终点
Determine changes in sexual well-being for women with breast cancer

研究概览

简要总结

In the present study, we propose a mixed methods approach to characterize and address the sexual health needs among women with breast cancer at the time of diagnosis and throughout treatment.

详细描述

In the present study, we propose a mixed methods approach to characterize and address the sexual health needs among women with breast cancer at the time of diagnosis and throughout treatment. The objectives are as follows:

  1. To characterize the sexual well-being of women longitudinally throughout the continuum of care, from initial diagnosis into survivorship.

We predict that treatment will adversely affect sexual well-being, and that patient factors, clinical factors, and treatment choices will influence changes in sexual well-being. 2. To identify gaps is sexual health education provided at the time of diagnosis or during treatment and to determine the appropriate timing of sexual health education delivery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients diagnosed with ductal carcinoma in situ or invasive breast cancer, seen in the breast center between 09/01/2019 to present, will potentially be recruited to participate.

排除标准

  • Patients less than 18 years of age and those with non-cancer diagnoses or prior history of breast cancer will be excluded.

研究组 & 干预措施

Stage 0

Ductal carcinoma in situ. Timing: start of endocrine therapy

干预措施: Focus Group (Behavioral)

Stages I-III Surgery first

Invasive cancer. Surgery first Timing: start of endocrine therapy

干预措施: Focus Group (Behavioral)

Stages I-III, neoadjuvant chemotherapy first

Invasive cancer. Neoadjuvant chemotherapy first Timing: during neoadjuvant chemotherapy

干预措施: Focus Group (Behavioral)

Stage IV

Metastatic cancer, chemotherapy only, no invasive surgery Timing: 2 months into treatment

干预措施: Focus Group (Behavioral)

Survivors

Timing: any time

干预措施: Focus Group (Behavioral)

结局指标

主要结局

Determine changes in sexual well-being for women with breast cancer

时间窗: 1 year

Determine changes in sexual well-being throughout the course of breast cancer treatment, pre- and post-implementation of developed educational materials using the Sexual Health Among Women Receiving Breast Cancer Treatment Survey

Determine patients preferred type of education for sexual health

时间窗: 1 year

Determine the patients preferred type and timing of educational interventions for sexual health using the Sexual Health Among Women Receiving Breast Cancer Treatment Survey

Determine educational resources currently used for sexual health information

时间窗: 1 year

Determine patients' self reported list of educational media received regarding sexual health during breast cancer treatment using the PROM survey (BREAST-Q)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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