Online Mindfulness-based Stress Reduction Intervention for Patients With Breast Cancer Receiving Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Stress
研究概览
简要总结
The goal of this prospective, waitlist-controlled, 1:1 randomized study is to evaluate if an online mindfulness-based intervention (MBI) reduces treatment-related stress levels among patients with breast cancer receiving chemotherapy.
The main questions it aims to answer are:
- Does an online MBI intervention reduce stress levels (measured through the Perceived Stress Scale) among participants?
- Does an online MBI intervention reduce anxiety, depression, insomnia, fatigue, nausea, diarrhea, constipation, pain, and peripheral neuropathy (measured through the PRO-CTCAE of the National Cancer Institute) among participants?
Researchers will compare the online MBI to no intervention to see if online MBI reduces treatment-related stress.
Participants will:
- Participate in an online MBI or no intervention for 6 weeks
- Answer the study surveys at baseline, 7 weeks, and 11 weeks of follow-up
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 (Outcomes Assessor)
盲法说明
Given the nature of the intervention, the study will be open and participants will know which group they were randomized to. However, the study will be blinded to the statistician in order to reduce the risk of introducing bias when interpreting the data.
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
- •Female sex
- •Age ≥18 years
- •Diagnosis of non-metastatic breast cancer
- •Treatment with neoadjuvant or adjuvant chemotherapy or plan to start chemotherapy in <4 weeks
- •Internet access at home or in their mobile phone
- •Availability to participate in the online MBI for 6 weeks
- •Availability to answer the study surveys
- •Provision of signed informed consent
排除标准
- •Disease recurrence
- •Current meditation or mindfulness practice
- •Inability to read or write
研究组 & 干预措施
Intervention group
The intervention group will be assessed with the study surveys at baseline (T1), will participate in the online MBI for the next 6 weeks, and will be subsequently reassessed with the study surveys at 7 weeks (T2) and at 11 weeks (T3) of follow-up.
干预措施: Online mindfulness-based stress reduction (Other)
Wait-list control group
A wait-list control group will be used with the objective that all participants have the opportunity of receiving the online MBI and at the same time allow comparison of the effectiveness of the program with a group without intervention. Given that treatment-related stress has an important negative impact on patients' wellbeing, it is appropriate to offer the control group the possibility of receiving the intervention if its effectiveness is demonstrated.
The control group will be assessed with the study surveys at baseline (T1), will not participate in the online MBI for the next 6 weeks, and will be subsequently reassessed with the study surveys at the same timepoints as the intervention group at 7 weeks (T2) and at 11 weeks (T3) of follow-up. Upon completion of recruitment and follow-up of all participants, the study will end, and the control group will be able to receive the online MBI according to their preference.
结局指标
主要结局
Stress
时间窗: 11 weeks
Measured through the Perceived Stress Scale (PSS). The PSS is a self-report instrument that assesses the level of perceived stress over the past month. It consists of 10 items that are rated using a 5-point Likert scale (0: Never; 1: Almost never; 2: Sometimes; 3: Fairly often; 4: Very often). The total score is obtained by adding the scores of the 10 items, obtaining a total value between 0-40, where higher scores indicate a higher level of perceived stress. A moderate stress level is considered between 14-26 points, and a high stress level is considered when obtaining \>27 points.
次要结局
未报告次要终点
研究者
Fernanda Mesa-Chavez
Principal Investigator
Tecnologico de Monterrey