A Pilot Study of a Brief Pre-Operative Intervention for Patients Undergoing Breast Surgery
研究概览
详细说明
Fifty participants will complete questionnaires at baseline (Day 1), then they will be randomized 1:1 to the Positive Piggy Bank condition (n=25) or Treatment as Usual (n = 25) approximately 3 weeks before surgery. Post-intervention (Day of Surgery) and 14 days post-surgery, participants will complete the same questionnaires. The 14 day post surgery questionnaires will be administered by phone.
Intervention Procedures - The Positive Piggy Bank. Participants randomized to this group will first get an overview of the intervention, learn about the rationale for this treatment, and receive supplies including the instructions on a decorative card, a piggy bank, and paper currency slips (pieces of lined paper with a place for the date). Participants in this group will be instructed to do the activities as detailed above in the Positive Piggy Bank instructions daily until the evening before surgery (approximately 21 days). On the evening before surgery, they are to "close their account" by opening the piggy bank and reviewing all of the slips of paper.
Study personnel will contact patients within 72 hours of beginning the study to answer questions and/or provide encouragement. Participants will also be contacted on the day before surgery to let them know that they should read all of their currency slips and reminded to bring their currency slips with them to the hospital on the day of surgery.
On the day of surgery, prior to surgery they will complete the first set of follow-up questionnaires. They will also be reminded that these same follow-up questionnaires will be administered by phone 14 days after surgery.
The control group will serve to show the relative benefits of the Positive Piggy Bank intervention. These participants will follow the same questionnaire completion procedures as listed above including phone calls. The phone call at 72 hours will be to simply thank them for their participation in the study.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Michigan
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Ann Arbor、Michigan、美国、48106
- University of Michigan, Chronic Pain and Fatigue Research Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Recent diagnosis of breast cancer with pending surgery as primary treatment for breast cancer.
- Ages 18 and above.
- Able to read/understand English and give consent.
- Willing and able to comply with all aspects of study procedures.
- No plan to initiate a new program that could affect well-being during the study period (e.g., psychotherapy, new exercise regimen, meditation classes).
Exclusion Criteria:
- Planned neoadjuvant systemic therapy.
- Having a psychotic disorder or the presence of another psychiatric condition (e.g., severe depression [i.e., score on the PHQ-9], suicidal ideation) or cognitive impairment (e.g., severe dyslexia, traumatic brain injury) limiting ability to give consent and/or participate fully in the study.
- Other factors that at the discretion of the investigators would adversely affect study.
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Positive Activities Intervention
Patients will note at least one positive event each day, write it down on a slip of paper and then deposit this piece of paper in a piggy bank.
After approximately 21 days, the participant reads each one the night before surgery.
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The PPB intervention involves noting at least one positive event each day, writing it down on a slip of paper and then depositing this piece of paper in a piggy bank.
This practice is to take place at the end of the day, every day over a circumscribed period of time.
At the end of the "deposit period" the participant "closes the account" and makes a full withdrawal by taking all of the slips out of the piggy bank and reading each one the night before surgery.
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无干预:Usual Care Group
The control group will serve to show the relative benefits of the Positive Piggy Bank intervention.
These participants will follow the same questionnaire completion procedures.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Feasibility of using a Positive Activities Intervention
大体时间:Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
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The primary objective of this study is to assess the feasibility of using a positive activities intervention, Positive Piggy Bank, in newly diagnosed women with breast cancer who will soon undergo surgery.
We will also explore changes in subjective well-being and post-surgical symptoms in response to the intervention in order to power a larger trial.
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Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Symptom Burden
大体时间:Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
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Measured by the MSAS
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Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
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Fatigue
大体时间:Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
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Measured by the PROMIS Profile 29
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Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
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Sleep
大体时间:Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
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Measured by the PROMIS Profile 29
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Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
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Depressive Symptoms
大体时间:Day 1 (baseline) to 14 Days Post Surgery
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Measured by the PROMIS Profile 29
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Day 1 (baseline) to 14 Days Post Surgery
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Social Roles
大体时间:Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
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Measured by the PROMIS Profile 29
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Day 1 (baseline), Day of Surgery and 14 Days Post Surgery
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合作者和调查者
调查人员
- 首席研究员:Afton Hassett, Psy.D.、University of Michigan
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- HUM00114087
- UMCC 2016.036 (其他标识符:University of Michigan Cancer Center)
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Positive Activities的临床试验
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University of ManchesterNational Secretariat of Science, Technology and Innovation in Panama (SENACYT)完全的
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Hospital Universitario GetafeKarolinska Institutet; Medical University of Lodz; Universidad Politecnica de Madrid; KTH Royal... 和其他合作者未知
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