Pelvic Floor Muscle Training Educational Intervention for Patients With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Feasibility-Quantitative and qualitative retention log
研究概览
简要总结
A PFMT educational intervention was designed for women with metastasic breast cancer. It consisted in a 120 min workshop and 8 weeks of non-supervised (but with follow-up) self-training. ICIQ, IQOL and ad hoc questions were performed before the workshop and after the 8 weeks training to see the prevalence of UI, the impact in their quality of life and the empowerment of self-training.
详细描述
Urinary incontinence (UI) affects women of all ages and has a great impact on the quality of life. Cancer treatments such as chemotherapy or hormone therapy may play an important rol in the development and worsening of pelvic floor disorders. Little evidence on the prevalence and impact of UI in metastassis breast cancer women is known.
A protocol was designed to analyze the effect of a PFMT educational intervention on the UI and the impact on the QoL, as well as in the empowerment feeling of the participants. Feasibility of the protocol will be analized to design an optimal RCT for testing our hypothesis
During the usual visits, oncologist wil recruit women with advanced breast cancer who meet the inclusion criteria for the participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Advanced breast cancer
- •Over 18 years old
- •No inestable bone metastasis
- •life expentancy>6 months
- •Literate in spanish
排除标准
- •Physical exercise contraindications
- •Intense pain
- •Being pregnant
研究组 & 干预措施
Intervention
PFMT educational intervention including a 120 min workshop and 8 weeks of self training
干预措施: PFMT educational intervention (Behavioral)
结局指标
主要结局
Feasibility-Quantitative and qualitative retention log
时间窗: 8 weeks
Information about number of participants who dropped out, and reason for drop-out
Feasibility- Satisfaction with the workshop
时间窗: baseline
A satisfaction 9 item questionnaire was design (Scale 1-5) to obtain information about the satisfaction with the (1) duration, (2) the content, (3) explanations, (4) atmosphere (5)number of participants during the workshop and (6) the importance for other patients to access this information, (7) increase in knowledge, (8) knowledge to train alone and (9) overall satisfaction.
Feasibility- Adherence to the program
时间窗: 8 weeks
Adherence will be difined as the percentage of completed weeks of training out of 8 weeks. A week will be considerered valid when the train was performed at least in 2 different days.
Feasibility- Recruitment rates
时间窗: 8 weeks
Number of patients enrolled divided by number of patients eligible
Prevalence of urinary incontinence
时间窗: baseline
By the ICIQ-UI Short Form, which is a questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence in men and women in research and clinical practice across the world. It has 4 items, and the scoring scale is 0-21.
Feasibility - Qualitative analyses of recruitment
时间窗: 8 weeks
Qualitative information regarding recruitment and reasons for patients not participating will be collected in the researchers log
次要结局
- Impact of urinary incontinence on the quality of life(8 weeks)
- Changes in urinary incontinence(8 weeks)
- Knowledge and empowerment(8 weeks)
研究者
Mireia Peláez Puente
PhD
Onkologikoa