Not Always ROSY-Feasibility of Addressing Sexual Dysfunction in Women with Breast and Gynecologic Cancers with a Novel Mobile Application
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in sex related personal distress as assessed by the Female Sexual Function Index (FSFI)
研究概览
简要总结
The purpose of this study is to identify breast and gynecologic cancer patients with sexual dysfunction, to measure sexual dysfunction with the Female Sexual Function Index (FSFI) and to provide Patients with the opportunity during this six-month period to follow up with a healthcare provider to discuss the sexual dysfunction needs and to see if a medical intervention can be of aid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Patient with a current or historic diagnosis of breast cancer or gynecologic cancer (uterine ovarian, fallopian tube, peritoneal, cervical, vulva, or vaginal cancers)
- •Agree to participate in the study with completion of survey and use of ROSY mobile application
排除标准
- •Currently pregnant
- •Non-English speaking (ROSY is currently is only available is in English).
结局指标
主要结局
Change in sex related personal distress as assessed by the Female Sexual Function Index (FSFI)
时间窗: Baseline, 6 months
FSFI is a 19-item instrument that measures 6 domains of sexual function: Desire, Arousal, Lubrication, Orgasm, Satisfaction, and Pain. This uses a Likert-type scale, with scores ranging from 0 to 5, except for questions 1, 2, 13, and 16, which are scored from 1 to 5. The total score ranges from 2.0 to 36.0, with higher scores indicating better functioning.
Change in sexual dysfunction as assessed by the Social Determinants of Health (SDOH) questionnaire
时间窗: Baseline, 6 months
score ranges from 0 to 10, higher score showing worse outcome
次要结局
- Change in sex related personal distress as assessed by the Female Sexual Function Index (FSFI) in ethnic minority groups(end of study (6 months after baseline))
- Change in sex related personal distress as assessed by the Female Sexual Function Index (FSFI) in sexual and gender minority groups(end of study (6 months after baseline))
- Change in sex related personal distress as assessed by the Female Sexual Function Index (FSFI) in unpartnered women(end of study (6 months after baseline))
研究者
Lavanya Palavalli Parsons
Assistant Professor
The University of Texas Health Science Center, Houston