A Multimodal Intervention 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
- 47
- 试验地点
- 2
- 主要终点
- Feasibility Primary Endpoint
研究概览
简要总结
This research study is evaluating the feasibility and impact of an intervention to improve sexual function in stem cell transplant survivors on participants' sexual function, quality of life, and mood.
- It is expected that about 50 stem cell transplant survivors will take part in this research study.
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 introduction of an intervention focused on improving sexual function may improve a participant's overall care and quality of life.
The intervention includes a comprehensive assessment by a transplant clinician who is trained in sexual dysfunction assessment to explore the reasons for sexual dysfunction and focus on ways to improve the participant's symptoms. The study will use a series of questionnaires to measure a participant's sexual function, quality of life, and mood.
The main purpose of this study is examine whether this intervention is feasible and helpful for participants in terms of improving their symptoms and overall quality of life.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years) with hematologic malignancy who underwent an allogeneic HCT at least 6 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 National Comprehensive Cancer Network survivorship guidelines
排除标准
- •Patients with relapsed disease post-HCT.
- •Significant psychiatric or other co-morbid disease, which the treating clinician believes prohibits the patient's ability to participate in the informed consent procedures.
结局指标
主要结局
Feasibility Primary Endpoint
时间窗: 6 months
intervention deemed feasible if at least 75% of patients screening positive for sexual dysfunction causing distress agree to participate and at least 80% complete at least one additional follow-up visit. This is not a composite outcome. Study is deemed feasible (yes) if both criteria are met.
次要结局
- Change in Quality of Life: Functional Assessment of Cancer Therapy- Bone Marrow Transplant(Baseline to 6 Months)
- Change in Sexual Function: Promis Sexual Function and Satisfaction Measure(Baseline to 6 Months)
- Change in Psychological Distress Scores - Hospital and Anxiety Depression Scale and Patient Health Questionnaire-9(Baseline to 6 Months)
研究者
El-Jawahri, Areej,M.D.
Principal Investigator
Massachusetts General Hospital