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Clinical Trials/NCT04601272
NCT04601272
Completed
N/A

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

Massachusetts General Hospital1 site in 1 country240 target enrollmentSeptember 29, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Breast Cancer Screening
Sponsor
Massachusetts General Hospital
Enrollment
240
Locations
1
Primary Endpoint
Shared Decision Making Process Measure
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 29, 2020
End Date
June 24, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Karen Sepucha

Director, Health Decision Sciences Center

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Shared Decision Making Process Measure

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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