Patient-Centered Risk Adjusted Surveillance After Curative Resection of Colorectal Cancer
The long-term goal of this research is to develop new tools to guide patients, caregivers, and clinicians in making individualized decisions regarding colorectal cancer (CRC) surveillance. As part of a Patient-Centered Outcomes Research Institute-funded contract, investigator will analyze surveillance data to determine the effectiveness of CRC surveillance and recurrence risk taking into account different patient and tumor characteristics; identify key issues about CRC surveillance important to patients, caregivers, and clinicians; and integrate the recurrence risk and patient priorities into a patient-centered, risk stratified surveillance strategy by creating an interactive decision aid for use by patients and clinicians.
This protocol addresses a formative step in the creation of the interactive decision aid where patients' information needs and preferences are assessed regarding decisions about surveillance.
The specific aims of this protocol are:
Phase 1 - To interview patients and their caregivers to determine their concerns, preferences and key priorities regarding surveillance after curative resection of colorectal cancer, and
Phase 2 - To refine the key priorities identified in phase 1 through focus groups and surveys with patients and caregivers.
研究概览
地位
条件
详细说明
You are being asked to take part in this research study which is conducted at The University of Texas MD Anderson ("MD Anderson") and the Harris Health System because you (or someone you act as a caregiver for) are undergoing follow-up after curative resection of colorectal cancer.
The goal of this study is to find out the key priorities for patients and their caregivers when it comes to surveillance after curative resection of colorectal cancer. Your responses will help develop decision aids to help future colorectal cancer patients make more informed decisions about surveillance.
If you agree to participate in this study, you will take part in an interview or focus group in person at MD Anderson, the Harris Health System, or the Alliance. The interview or focus group is expected to take between 30 minutes and 1 hour. The interview or focus group will be audiorecorded. Your name or other identifying information will not appear in the transcript. Adept Word Management, a transcription service that has been approved by the institution, may transcribe the interviews.
You will be asked questions about:
- your priorities and concerns about colorectal cancer surveillance
- what you know about colorectal cancer and surveillance,
- your cancer and treatment (or the patients'),
- the impact or inconvenience that surveillance causes,
- who you think should make decisions about surveillance,
- your thoughts about different surveillance scenarios,
- and general questions about your age, race, sex, education, and income level.
Information about you will be collected from the medical records and existing data in a database of colorectal patients that is used to organize existing information about colorectal patients to better understand the disease. Information collected will include things like age, gender, marital status, information about the tumor, type of surgery, and what treatment was done before and after surgery. There are no other plans to share your information with others outside the study.
Your participation will be over when the interview is complete. If you are undergoing follow-up for colorectal cancer, research staff will look at your medical record after the interview for information about your cancer including tumor characteristics.
Your participation is completely voluntary. Whether you say yes or no will not change your medical care.
Up to 220 patients and their caregivers will participate in this multicenter study. Up to 190 patients and their caregivers will be enrolled at MD Anderson. Up to 10 patients and their caregivers will be enrolled at the Harris Health System.
研究类型
注册 (实际的)
联系人和位置
学习地点
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California
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San Francisco、California、美国、94143
- University of California San Francisco
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Texas
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Houston、Texas、美国、77030
- University of Texas MD Anderson Cancer Center
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Houston、Texas、美国、77026
- Lyndon B. Johnson General Hospital
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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
取样方法
研究人群
描述
Inclusion Criteria:
- Age 21 or older
- Able to read and speak English
- Able to undergo a 30 to 60-minute interview or focus group
- For phase 1: MD Anderson patient undergoing follow-up for curative resection of stage I-IV colon or rectal cancer OR caregiver of such a patient
- For phase 2: Colon or rectal cancer patient
Exclusion Criteria:
N/A
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Colorectal Cancer Participants
Colorectal cancer participants undergoing follow-up after curative resection of colorectal cancer.
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Semi-structured interviews conducted exploring key issues relevant to colorectal cancer surveillance following curative resection.
Interviews take between 30 minutes and 1 hour.
Questionnaire completion asking general health and demographic questions.
其他名称:
Focus groups conducted with participants and caregivers.
Up to 4 focus groups conducted with up to 30 participants each.
Focus groups expected to take 30 to 60 minutes.
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Caregivers of Colorectal Cancer Participants
Caregivers of colorectal cancer participants undergoing follow-up after curative resection of colorectal cancer.
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Semi-structured interviews conducted exploring key issues relevant to colorectal cancer surveillance following curative resection.
Interviews take between 30 minutes and 1 hour.
Focus groups conducted with participants and caregivers.
Up to 4 focus groups conducted with up to 30 participants each.
Focus groups expected to take 30 to 60 minutes.
Semi-structured interviews conducted exploring key issues relevant to colorectal cancer surveillance following curative resection.
Interviews take between 30 minutes and 1 hour.
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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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Effectiveness of Colorectal Cancer (CRC) Surveillance
大体时间:1 day
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Semi-structured interviews and focus groups reviewed to identify themes related to participants' and caregiver's priorities regarding surveillance of colorectal cancer.
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1 day
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合作者和调查者
调查人员
- 首席研究员:Robert Volk, PHD、M.D. Anderson Cancer Center
- 学习椅:George J. Chang, MD,MS、M.D. Anderson Cancer Center
出版物和有用的链接
一般刊物
- Zafar SN, Hu CY, Snyder RA, Cuddy A, You YN, Lowenstein LM, Volk RJ, Chang GJ. Predicting Risk of Recurrence After Colorectal Cancer Surgery in the United States: An Analysis of a Special Commission on Cancer National Study. Ann Surg Oncol. 2020 Aug;27(8):2740-2749. doi: 10.1245/s10434-020-08238-7. Epub 2020 Feb 20.
- Snyder RA, Hu CY, Cuddy A, Francescatti AB, Schumacher JR, Van Loon K, You YN, Kozower BD, Greenberg CC, Schrag D, Venook A, McKellar D, Winchester DP, Chang GJ; Alliance for Clinical Trials in Oncology Network Cancer Surveillance Optimization Working Group. Association Between Intensity of Posttreatment Surveillance Testing and Detection of Recurrence in Patients With Colorectal Cancer. JAMA. 2018 May 22;319(20):2104-2115. doi: 10.1001/jama.2018.5816.
研究记录日期
研究主要日期
学习开始 (实际的)
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
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