The MEDITATE-BC Study: Mindfulness-Enhanced Decision Intervention To Aid Treatment Election - Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Acceptability of a mindfulness intervention prior to the surgical consultation measured by adherence to the intervention.
研究概览
简要总结
In this study the investigators propose to pilot test a brief, mindfulness shared decision making intervention that begins shortly after receiving a diagnosis of breast cancer. A mindfulness instructor will conduct an hour long session with consented participants before the scheduled surgical appointment. The investigators hypothesize that a mindfulness intervention delivered shortly after receiving a diagnosis of breast cancer may ultimately lead to increased decisional satisfaction and alignment to participant's values and preferences, and decreased anxiety. To measure this endpoint, participants will complete three surveys via REDCap- at baseline, before surgery, and 6 months postoperatively. Surveys will include questions on quality of life, anxiety, and participant satisfaction with the mindfulness program.
详细描述
The primary aim of this study is to identify if a mindfulness intervention is feasible before the participant has their surgical consultation. The secondary aim is to measure the impact of the mindfulness intervention on participant reported outcomes including anxiety, quality of life and decisional satisfaction. Newly diagnosed female breast cancer patients will be contacted over the phone after the patient learns of their diagnosis but prior to their surgical appointment to discuss surgical options. Verbal consent will be obtained over the phone and the participant will be directed to complete an online survey to answer baseline questions on their anxiety and quality of life as well as to provide their contact information and availability in order to schedule a mindfulness session with a certified mindfulness teacher. The participant will then proceed to an hour-long mindfulness exercise geared to help women apply these techniques to the decisional making process. The goal is to empower women to approach their diagnosis and treatment decisions with greater stability and improve their ability to focus on their values and preferences instead of just focusing on the diagnosis. This will be measured by administering patient reported outcomes (PROs) via REDCap online surveys at three timepoints. The first PRO "baseline survey" is administered after the participant enrolls but before the mindfulness session. The second PRO "before surgery survey" is completed after the surgical consultation but prior to the scheduled surgery. The final PRO "6-month survey" is administered 6 months after the surgery to measure quality of life, anxiety, and participant satisfaction with the mindfulness program. The investigators hypothesize that a mindfulness intervention delivered shortly after receiving a diagnosis of breast cancer may ultimately lead to increased decisional satisfaction and alignment to participant's values and preferences, and decreased anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females >20 and < 70 years of age
- •History of contralateral breast cancer in the past is acceptable
- •Patients seeking second opinion for diagnosis are eligible
- •Clinical AJCC stage 0-III breast cancer
- •Patients who have an in breast tumor recurrence are eligible
- •English Speaking
- •Willing to fill out surveys required for the study
- •Gene mutation carriers are eligible
- •Neoadjuvant therapy patients are eligible
排除标准
- •AJCC Stage IV breast cancer
- •Unwilling to fill out surveys for the study
- •Patients with a distant recurrence
- •Patients unaware of their diagnosis
结局指标
主要结局
Acceptability of a mindfulness intervention prior to the surgical consultation measured by adherence to the intervention.
时间窗: 1 year
The number of patients who have successfully completed their mindfulness session with the mindfulness instructor. Zero being not one completion, twenty-five being all have completed the mindfulness session.
Participant feedback via Questionnaire on the usefulness of the mindfulness experience on their emotional management and decision making process.
时间窗: 1 year
Two sets of questions asking about level of satisfaction with the mindfulness experience and how it pertains to their treatment decision satisfaction with responses being; 1. Not at all, 2. A little bit, 3. Somewhat, 4. Quite a bit, 5. Very much;
Feasibility of a mindfulness intervention prior to the surgical consultation by adherence to the mindfulness excercises.
时间窗: 1 year
The mindfulness instructor will conduct a follow-up session with the participant following their surgical consultation and measure the number of times the participant listened to the audio recordings given to them following their mindfulness session but prior to their surgical consultation.
Feasibility of a mindfulness intervention prior to the surgical consultation by proportion of participants who have contact with the mindfulness teacher.
时间窗: 1 year
Measurement will be done by looking at the ratio of participants consented versus participants completed the mindfulness intervention with the teacher.
Feasibility of a mindfulness intervention prior to the surgical consultation by measuring the length of time to schedule the participant with the mindfulness teacher.
时间窗: 1 year
This will be measured by comparing date the participant consented on the study to the date participant had successfully scheduled their mindfulness session.
Acceptability of a mindfulness intervention following the surgical consultation measured by adherence to the follow up session.
时间窗: 1 year
The number of patients who have successfully completed their mindfulness follow up session with the mindfulness instructor. Zero being not one completion, twenty-five being all have completed the mindfulness session.
Feasibility of a mindfulness intervention prior to the surgical consultation by a single question regarding mode of communication participants prefer.
时间窗: 1 year
Options include by phone, video conference, or in-person
Feasibility of a mindfulness intervention prior to the surgical consultation by calculating proportion of participants who consent to the study.
时间窗: 1 year
Measurement will be done by looking at the ratio of participants approached versus participants consented to the study.
次要结局
- Patient Reported Outcomes on quality of life(2 years)
- Patient Reported Outcomes on mindfulness outcome(2 years)
- Patient Reported Outcomes on decisional satisfaction(2 years)
- Patient Reported Outcomes and value concordant decision making(2 years)
- Patient Reported Outcomes on anxiety(2 years)
- Patient Reported Outcomes on fear of recurrence(2 years)
研究者
Katharine Yao, MD
Chief, Division of Surgical Oncology
NorthShore University HealthSystem