Evaluation of a Brachytherapy Discharge Education Program (BrachDEP) to Improve Patient Care: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Patient Satisfaction with access to education (CBI)
研究概览
简要总结
Although brachytherapy is an effective treatment modality for gynecological cancer, a significant proportion of patients develop late treatment-related vaginal toxicity, negatively impacting their quality of life and limiting recurrent disease detection by preventing adequate clinical examination during the post-treatment surveillance period. Consistent with the literature, results from a study at Princess Margaret revealed that current vaginal toxicity management education and training may be inadequate. The investigators seek to implement and evaluate a new online brachytherapy discharge education program (BrachDEP) to support patient engagement in self-management.
详细描述
Background:
Brachytherapy is a type of radiation therapy used to treat patients with gynecological cancers. Brachytherapy delivers radiation to cancerous tissue by inserting or placing the radiation next to the target tissue. A common side effect that develops as a result of repeated brachytherapy is fibrosis, a thickening and hardening of tissue, as well as narrowing of the vagina, known as vaginal stenosis. To reduce the impact of vaginal stenosis, vaginal dilation is recommended upon discharge of brachytherapy. Vaginal dilation involves the insertion of a smooth plastic tube into the vagina 3 to 4 times per week. Despite the benefits of vaginal dilation, use of vaginal dilators is low among patients following brachytherapy. This poor adherence to vaginal dilator use may be due to embarrassment, discomfort, and lack of awareness of the benefits to patients.
Objective:
The primary objective of this study is to evaluate the whether an online brachytherapy discharge education program increases patient satisfaction with education and care. Secondary objectives are to determine whether the online education program increases patient quality of life, improves vaginal dilator compliance and reduces rates of vaginal stenosis post-treatment.
Methods:
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
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Scheduled to receive brachytherapy for treatment of gynecologic cancer at Princess Margaret Cancer Centre.
- •Able to provide written informed consent
- •Able to read and write in English
- •> 18 years of age
排除标准
- •Not receiving brachytherapy treatment
研究组 & 干预措施
Online education
Participants will gain access to the online education modules in addition to receiving current standard of care education (pamphlets and one on one teaching with health care provider)
干预措施: Online education (Other)
Regular standard of care education
Participants only receive current standard of care education (pamphlets and one on one teaching with health care provider)
干预措施: Regular standard of care education (Other)
结局指标
主要结局
Patient Satisfaction with access to education (CBI)
时间窗: 1 year
To determine whether the online brachytherapy discharge education program increases patient satisfaction with education and care. CBI: Cancer Behavioural Inventory Brief min score: 12 max score: 108 higher scores indicates greater coping efficacy
Patient Satisfaction with access to education (EORTC-QOL)
时间窗: 1 year
To determine whether the online brachytherapy discharge education program increases patient satisfaction with education and care. Quality of Life min score: 1 max score 100 higher score indicates higher level of functioning
Patient Satisfaction with access to education (SVQ)
时间窗: 1 year
To determine whether the online brachytherapy discharge education program increases patient satisfaction with education and care. The sexual function vaginal changes questionnaire higher scores indicate better overall sexual functioning
Patient Satisfaction with access to education (EQ-5D-5L)
时间窗: 1 year
To determine whether the online brachytherapy discharge education program increases patient satisfaction with education and care. Health Status min value set: 11111 max value set: 55555 lower value set indicates better health min score: 0% max score: 100% higher percentage indicates best possible health
Patient Satisfaction with access to education (PS-CaTE)
时间窗: 1 year
To determine whether the online brachytherapy discharge education program increases patient satisfaction with education and care. Patient Satisfaction with Cancer Treatment Education min score = 1 max score = 5 higher score indicates greater satisfaction with information
次要结局
- Rates of vaginal stenosis(1 year)