Effects of Implementing a Post-surgical Dietary and Lifestyle Protocol on Uterine Fibroid Recurrence
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Uterine Fibroid
- 发起方
- NYU Langone Health
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in fibroid recurrence as measured by standard of care ultrasounds
- 状态
- 进行中（未招募）
- 最后更新
- 3个月前
概览
简要总结
The study will evaluate a lifestyle, nutrition, and exercise program to assess whether this program is acceptable and feasible for patients..Researchers will examine if the LIFE program can modify fibroid recurrence.
详细描述
This prospective cohort pilot study will enroll asymptomatic, post-surgical patients who underwent a laparoscopic, open, robotic myomectomy, or other procedure ie Sonata, Accessa for fibroid removal. Patients will be offered enrollment into a lifestyle, nutrition, supplement, and exercise program to assess whether this program is acceptable and feasible for patients. Surveys will be collected at 3-6 month intervals.
研究者
入排标准
入选标准
- •Participants ages 18-50, who are seeking care at the Center for Fibroid Care at NYU
- •Participants who have had a procedure or surgery performed to removed fibroids within the last 3 months and are now considered "fibroid free."
- •Be English speaking and be able to read/write in English
- •Visit with PCP within the last 3 months with labs
排除标准
- •Currently Pregnant
- •Use of any medication, hormonal or GNRH agonists, that would affect fibroid growth
- •Postmenopausal women
- •Non-English speaking
- •Fibroid procedure or surgery outside of the 3-month window
- •Women who are physically incapable of following a physical activity regimen
- •Women with multiple dietary restrictions that would impact their ability to follow recommended dietary plan. (ie. GI disorders)
结局指标
主要结局
Change in fibroid recurrence as measured by standard of care ultrasounds
时间窗: Baseline, 6 month, 12 month
Adherence to a lifestyle program changes rate of fibroid recurrence as assessed by standard of care pelvic ultrasound results.
Acceptability of LIFE program as measured by Self report survey
时间窗: 12 month visit.
Patient satisfaction survey will assess if patients found the program acceptable on a 5 point Likert scale ( not at all acceptable, fair, moderate, good excellent).
Change in improvement in quality of life as measured by Quality of Life Scale (QOLS)
时间窗: Baseline, 6 month, 12 month
The Quality of Life Scale (QOLS) was originally a 15-item instrument that measured five conceptual domains of quality of life: material and physical well-being, relationships with other people, social, community and civic activities, personal development and fulfillment, and recreation. Using a 7-point response scale, scores are summed so that a higher score indicates higher quality of life. The QOLS is scored by adding up the score on each item to yield a total score for the instrument. Scores can range from 16 to 112.