Randomized Trial of a Multimodal Sexual Dysfunction Intervention for Hematopoietic Stem Cell Transplant Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Compare Patient Global Satisfaction with Sex
研究概览
简要总结
This research study is evaluating the 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 120 people who have undergone a stem cell transplant 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 Investigators 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 main purpose of this study is to compare two types of care - the study intervention versus enhanced standard care which includes receiving an educational handout about sexual dysfunction. The main goal is to assess if the intervention will improve participant's sexual function, quality of life, and mood.
The intervention includes a comprehensive assessment by a transplant clinician (a transplant physician or nurse practitioner) who is trained in sexual dysfunction assessment to explore the reasons for sexual dysfunction and focus on ways to improve symptoms.
-- If the transplant clinician feels additional help is needed by a sexual health expert, the participant will be referred to the sexual health clinic. In the sexual health clinic, the participant will be evaluated by an expert physician who will also focus on strategies to improve sexual function.
The study will use a series of questionnaires to measure sexual function, quality of life, physical symptoms, and mood. Study questionnaires will be completed in the clinic or remotely with assistance provided as needed.
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) with hematologic malignancy who underwent autologous or allogeneic HCT ≥ three months prior to study enrollment.
- •Positive screen for sexual dysfunction that is causing distress based on the National Comprehensive Cancer Network (NCCN) survivorship guidelines
- •Ability to read and respond to questions in English or to complete questionnaires with assistance from an interpreter.
排除标准
- •Patients with relapsed disease requiring treatment
- •Patients with a planned second transplant
- •Patients > 5 years from their HCT
- •Patients with psychiatric or cognitive conditions which the treating clinicians believes prohibits compliance with study procedures.
研究组 & 干预措施
Enhanced Standard Care
- Baseline data collection, registration and randomization
- Inform primary transplant clinician of sexual dysfunction causing distress
- Receive American Cancer Society sexual educational material
干预措施: Enhanced Standard Care (Behavioral)
Multimodal Intervention to Address Sexual Dysfunction
-
Baseline data collection, registration and randomization
-
3 Monthly visits with trained study nurse practitioners
-
Referral to specialist if
-
Psychological etiology
-
Sexual Trauma
-
Relationship Discord
-
Concern for Malignancy or anatomic scarring requiring surgery
干预措施: Multimodal Intervention to Address Sexual Dysfunction (Behavioral)
结局指标
主要结局
Compare Patient Global Satisfaction with Sex
时间窗: 3 Months
compare patients' global satisfaction with sex using PROMIS Sexual Function and Satisfaction Measure (global satisfaction domain) at three months between the study groups using linear regression controlling for baseline values (as necessary for any imbalances in baseline variables
次要结局
- For females: compare patient-reported vaginal comfort longitudinally(up to 6 months)
- Compare Patient Reported Quality of Life(3 Months)
- Compare Patient Reported Anxiety Symptoms Longitudinally(up to 6 months)
- Compare Patient Reported Depression Symptoms(3 Months)
- Compare Patient Reported Depression Symptoms Longitudinally(up to 6 Months)
- For females: compare patient-reported vaginal lubrication longitudinally(up to 6 months)
- For females: compare patient-reported vaginal comfort(3 months)
- Compare patient-reported orgasm(3 Months)
- Compare patient-reported orgasm longitudinally(up to 6 months)
- Compare Patient global satisfaction with sex longitudinally(up to 6 months)
- Compare Patient reported interest in sexual activity longitudinally(up to 6 months)
- For males: compare patient-reported erectile function longitudinally(up to 6 months)
- Compare Patient reported interest in sexual activity(3 Months)
- Compare Patient Reported Anxiety Symptoms(3 Months)
- For males: compare patient-reported erectile function(3 Months)
- For females: compare patient-reported vaginal lubrication(3 Months)
- Compare Patient Reported Quality of Life longitudinally(up to 6 months)
研究者
El-Jawahri, Areej,M.D.
Principal Investigator
Massachusetts General Hospital