Multimodal Mobile Intervention Application (App) to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Feasibility Based on Proportion of Subjects Enrolled
研究概览
简要总结
This research study is being done to evaluate whether the use of a mobile app can help transplant survivors experiencing sexual health problems.
详细描述
Frequently survivors of stem cell transplantation report significant problems with their sexual function that impacts their quality of life, mood, and their intimacy and relationship with their partners. These issues can be very distressing to patients and their loved ones. The study doctors want to know if the use of a mobile app intervention focused on improving sexual function may improve participants overall care.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years) who underwent an autologous or allogeneic HCT at least 3 months prior to study enrollment.
- •Ability to speak English or able to complete questionnaires with assistance required from an interpreter or family member.
- •Positive screen for sexual dysfunction that is causing distress based on the NCCN survivorship guidelines
排除标准
- •Recurrent disease requiring treatment
- •Significant uncontrolled psychiatric disorder (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the treating clinician believes prohibits the ability to participate in study procedures.
结局指标
主要结局
Feasibility Based on Proportion of Subjects Enrolled
时间窗: 2 years
feasibility will be a priori defined as at least 60% o eligible patients enrolled in the study.
次要结局
- Compare Patient-reported Orgasm (PROMIS Sexual Function and Satisfaction Measure - Orgasm Domain) Between the Study Groups(8 weeks)
- Compare Patient-reported Global Satisfaction With Sex (PROMIS Sexual Function and Satisfaction Measure) Between the Study Groups(8 weeks)
- Compare Patient-reported Interest in Sexual Activity (PROMIS Sexual Function and Satisfaction Measure - Interest in Sexual Activity Domain) Between the Study Groups(8 weeks)
- For Males: Compare Patient-reported Erectile Function (PROMIS Sexual Function and Satisfaction Measure - Erectile Function Domain) Between the Study Groups(8 weeks)
- For Females: Compare Patient-reported Lubrication and Vaginal Comfort (PROMIS Sexual Function and Satisfaction Measure - Lubrication and Vaginal Comfort Domains) Between the Study Groups(8 weeks)
- Compare Patient Reported Quality of Life (FACT-BMT) Between the Study Groups(8 weeks)
- Compare Patient Reported Depression Symptoms (HADS-depression) Between the Two Study Groups(8 weeks)
- Compare Patient Reported Anxiety Symptoms (HADS-anxiety) Between the Two Study Groups(8 weeks)
研究者
El-Jawahri, Areej,M.D.
Principal Investigator
Massachusetts General Hospital