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临床试验/NCT03248258
NCT03248258已完成不适用

Enhancing Shared Decision-Making in Metastatic Breast Cancer (Qualitative Study)

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年6月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Shared Decision Making

研究概览

简要总结

Develop a Metastatic Breast Cancer (MBC)-specific electronic Treatment Plans (TP).

Phase 1:

Aim 1a: Patient interviews along with navigator, nurse, and physician focus group discussions will be used to identify factors that influence decision-making in treatment selection and the optimal approach for sharing information about prognosis and guideline-based care. Identify decisional needs for Shared Decision Making (SDM) in MBC. Investigators will conduct semi-structured interviews/discussion groups with patients, navigators, nurses, and physicians to elements important to decision-making.

Phase 2:

Aim 1b: Develop MBC-specific TP. Investigators will build upon Aim1a to systematically develop the TP intervention using the Ottawa Decision Support Framework. Investigators will test the TPs with 5 patients and conduct qualitative investigations to refine the TP using an iterative process.

Phase 3:Further explore decision-making related to reducing amount of chemotherapy for patients with good prognosis.

详细描述

Phase 1:

Investigators will use patient interviews and navigator, nurse, and physician focus group discussions to identify factors that influence decision-making in treatment selection and the optimal approach for sharing information about prognosis and guideline-based care. Patients will be recruited from the medical oncology clinic. Patients will be identified by their primary oncologist. All eligible patient will be provided with a study information flyer. All patient participants will be asked to provide written informed consent prior to participation in interviews; provider participants will be provided with Information sheets prior to focus groups by a research coordinator. Participants in Group 1 will be asked to complete a demographic form. The demographic forms for patients, navigators, nurses, and medical oncologists are included in Appendix B. Demographic form will include questions about your age, sex, race and education. The demographic form will take 5 minutes to complete. At study entry, descriptive data including patient demographics (age, sex, race), breast cancer characteristics (subtype, line of therapy, specific treatment offered, prior treatments received), physician will be collected to provide clinical context for the analysis. The patients will be interviewed at the patient's next appointment (either with the physician or in the infusion center) or the patients can schedule to come on an off clinic day of their preference. The study coordinators will offer each patient the option to complete the consent form at home. If they decide to complete the consent form at home investigators will follow up with by contacting them on the telephone to ensure that the consent form was completed and to confirm their interview at their next clinic visit or an off day of their preference. This 30 minute to an hour interview will take place in a private meeting room within the UAB Comprehensive cancer center. The patient interviews will be audio-recorded by using a digital audio recorder.

Phase 2:

Patients will be recruited from the medical oncology clinic. Patients will be identified by their primary oncologist. A trained research coordinator will consent the patient during a routine clinic visit. This group will consist of 5 new patients who did not participate in Group 1 patient interviews. Descriptive data including patient name and medical record number will be collected on a tracking sheet. No other personal identifiable information will be collected. This 30-minute interview will take place in the clinic room or a private room within the UAB Comprehensive cancer center (based on patient preference). The researcher will provide the patient with the iPad for completion of baseline patient-reported outcome questionnaires using the Carevive® platform for a test patient in a test environment which will not be linked to the patient's medical record. The intervention questionnaire will include standard questions used to routine treatment planning at UAB/MCI as well as any study-specific questions generated from Phase I above. This will allow feedback on the questionnaire itself. The research coordinator will then provide the patient with an example TP that includes responses to the questionnaire. The study PI will review the electronic or a printed version with the patient to get feedback on the acceptability of the TP, content of the TP, and the best approach to utilizing the TP. This process may be modified based on results of our qualitative analysis.

Investigators will conduct separate focus groups with each provider group. This will include 7 breast medical oncologists, 10 patient navigators, and 10 nurses (5 clinic nurses who work directly with the breast oncologists and 5 infusion nurses).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient Criteria (Phase I,II,III):
  • Inclusion Criteria:
  • 1. Women with age ≥ 18
  • 2. Presence of Metastatic Breast Cancer or Early Stage Breast Cancer
  • 3. Patients may be receiving any line and type of therapy including both standard of care and clinical trials.

排除标准

  • 1. Patient who are not able to read and/or speak English
  • 2. Patients with a life expectancy less than 3 months
  • 3. Patients unable to provide informed consent
  • Patient Advocates (Phase III)
  • Inclusion criteria:
  • 1. Providers who are self-identified patient advocates working with breast cancer researchers
  • Exclusion criteria:
  • Sampling: We will conduct interviews with 10-20 patient advocates for phase 3 of this project.
  • Provider (navigator, nurse, physician) (Pjhase I, III)
  • Inclusion criteria:
  • Providers who have direct contact with breast cancer patients
  • Exclusion criteria:

研究组 & 干预措施

Physician de-escalation Interview Participants

Physician Participants will be interviewed on the topic of de-escalation of cancer treatment. This will be a one time, one-on-one interview with a trained interviewer.

干预措施: Qualitative Interview or Focus group discussions (Other)

Metastatic Breast Interview Participants - Shared Decision Making

Metastatic Breast Patient Participants will be interviewed on the topic of Shared Decision Making. This will be a one time, one-on-one interview with a trained interviewer.

干预措施: Qualitative Interview or Focus group discussions (Other)

Early Stage Breast Interview Participants - Shared Decision Making

Early Stage Breast Patient Participants will be interviewed on the topic of Shared Decision Making. This will be a one time, one-on-one interview with a trained interviewer.

干预措施: Qualitative Interview or Focus group discussions (Other)

Provider Focus Group -Shared Decision Making

Clinic Provider Participants will participate in a focus group on the topic of Shared Decision Making. This will be a one time, focus group interview with a trained moderator.

干预措施: Qualitative Interview or Focus group discussions (Other)

Non-UAB Provider Shared Decision Making

Non-UAB Provider Participants will be interviewed on the topic of Shared Decision Making. This will be a one time, one-on-one interview with a trained interviewer.

干预措施: Qualitative Interview or Focus group discussions (Other)

Early Stage de-escalation Interview Participants

Early Stage Breast Patient Participants will be interviewed on the topic of de-escalation of cancer treatment. This will be a one time, one-on-one interview with a trained interviewer.

干预措施: Qualitative Interview or Focus group discussions (Other)

Patient Advocate de-escalation Interview Participants

Patient Advocate Participants will be interviewed on the topic of de-escalation of cancer treatment. This will be a one time, one-on-one interview with a trained interviewer.

干预措施: Qualitative Interview or Focus group discussions (Other)

Early Stage Feedback Interview Participants

Early Stage Breast Patient Participants will be interviewed to provide feedback on a decision making tool (video). This will be a one time, one-on-one interview with a trained interviewer.

干预措施: Qualitative Interview or Focus group discussions (Other)

结局指标

主要结局

Shared Decision Making

时间窗: 3 years

Shared decision making occurs when patients are informed of risks and benefits associated with treatment options and partner with their oncologist to incorporate their personal preferences and values into decision-making. Shared decision making in medicine can improve quality of care and reduce costs. This will be accessed using qualitative interviews and focus groups discussions. This is not a survey based study.

Concept of de-escalation

时间窗: 2 years

Patients reduce the amount of chemotherapy to avoid side effects

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gabrielle Rocque

Assistant Professor

University of Alabama at Birmingham

研究点 (1)

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