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临床试验/NCT04601272
NCT04601272已完成不适用

Evaluating the Performance of the Shared Decision Making Process Scale in Patients Making Cancer Screening Decisions

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2020年9月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
240
试验地点
1
主要终点
Shared Decision Making Process Measure

研究概览

简要总结

The purpose of this retrospective observational study is to evaluate the performance of the Shared Decision Making Process scale in a sample of patients who have received a decision aid about the decision to screen or not screen for breast cancer, colon cancer, prostate cancer, or lung cancer.

详细描述

This is a retrospective observational study that will examine the performance of the Shared Decision Making Process in a sample of patients who made a decision about cancer screening in the last 2 years. Patients from 4 hospitals who have received a patient decision aid for breast, colon, prostate, or lung cancer screening will be screened for eligibility. A random sample of eligible patients will be sent a one-time survey. The survey asks patients about their experiences talking with healthcare providers about the specific cancer screening decision. The survey includes the Shared Decision Making Process scale, knowledge, preferences, decisional conflict and decision regret. The study will obtain 400 completed surveys, or 100 for each cancer topic.

The sample consists of patients who received a decision aid for cancer screening within the last two years and meet specific qualifications.

All analyses will be conducted separately for each group, and results may be pooled. First, study staff examine the descriptives for the Shared Decision Making Process items. Study staff will also test several hypotheses to examine performance of the scores such as whether higher shared decision making process scores are associated with less decisional conflict and less regret.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
35 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Breast Cancer group
  • Female sex
  • Between ages of 35-55
  • No previous diagnosis of breast cancer
  • Colon Cancer Group
  • Between ages of 45-75
  • No previous diagnosis of colon cancer
  • Prostate Cancer Group
  • Between ages of 45-74
  • No previous diagnosis of prostate cancer
  • Lung Cancer Group
  • Between ages of 50-80
  • No previous diagnosis of lung cancer

排除标准

  • Breast Cancer group
  • Unable to confirm primary language is English
  • History of breast cancer
  • Severe cognitive impairment who cannot consent for themselves
  • Colon Cancer Group
  • Unable to confirm primary language is English
  • History of colon cancer
  • Severe cognitive impairment who cannot consent for themselves
  • Prostate Cancer Group
  • Unable to confirm primary language is English
  • History of prostate cancer
  • Severe cognitive impairment who cannot consent for themselves
  • Lung Cancer Group
  • Unable to confirm primary language is English
  • History of lung cancer
  • Severe cognitive impairment who cannot consent for themselves

结局指标

主要结局

Shared Decision Making Process Measure

时间窗: Baseline survey

The Shared Decision Making Process is a short patient-reported survey that measures the amount of shared decision making that occurs in an interaction. Scores range from 0-4 where higher values indicate a better shared decision making process outcome.

次要结局

  • Knowledge(Baseline survey)
  • Adapted Controlled Preference Scale(Baseline survey)
  • The 9-item Shared Decision Making Questionnaire(Baseline survey)
  • Treatment Choice(Baseline survey)
  • Decisional Conflict Tool (SURE)(Baseline survey)
  • Single-Item Measure of Decision Regret(Baseline survey)

研究者

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

Karen Sepucha

Director, Health Decision Sciences Center

Massachusetts General Hospital

研究点 (1)

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