Breast Cancer Clinical Trial

Online Trial Examining Validity and Reliability of the Shared Decision Making Process Survey

Summary

The purpose of this study is to survey a sample of adults who have recently made a decision about treatment of high cholesterol or high blood pressure or a decision about screening for colorectal cancer, breast cancer, or prostate cancer. The main goal is to gather evidence of the validity and reliability of the Shared Decision Making Process scale. Secondary goal is to gather evidence on the quality of decisions for these common medical situations.

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Full Description

Study staff worked with a national sampling firm to recruit subjects for five different medical decisions. The five decisions are (1) treatment of high cholesterol, (2) treatment of high blood pressure (3) when to start breast cancer screening (4) whether or not to have prostate cancer screening and (5) which test to have for colorectal cancer screening. Respondents complete a survey about their experiences talking with health care providers about the specific clinical decision. The survey measured the amount of shared decision making, knowledge, preferences, decisional conflict and decision regret. The study will obtain 500 responses total, or 100 for each decision.

Sample is an online non-probability panel of adults living in the United States. In the survey, participants were screened to meet specific qualifications. After 1 week, a random selection of 50 respondents are invited to complete the retest instrument.

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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

High Blood Pressure Group

Between the ages of 30-75
No previous heart attack or stroke
Have been diagnosed with high blood pressure
Taking medication for high blood pressure for 2 years or less; or have discussed managing high blood pressure in the past 2 years

High Cholesterol

Between the ages of 30-75
No previous heart attack or stroke
Have been diagnosed with high cholesterol
Taking medication for high cholesterol for 2 years or less; or have discussed managing high cholesterol in the past 2 years

Colorectal Cancer Screening

Between the ages of 50-75
No previous diagnosis of colon cancer
Have been screened for colon cancer (or discussed screening for colon cancer) in the past 2 years
Had first colon cancer screening in past 2 years

Breast Cancer Screening

Female
Between the ages of 40-55
No previous diagnosis of breast cancer
Have had mammogram (or discussed having a mammogram) in the past 2 years
Had first mammogram in past 2 years

Prostate Cancer Screening

Male
Between the ages of 45-69
No previous diagnosis of prostate cancer
Have been screened for prostate cancer (or discussed screening for prostate cancer) in the past 2 years
Had first prostate cancer screening in past 2 years

Exclusion Criteria:

High Blood Pressure Group

None

High Cholesterol

None

Colorectal Cancer Screening

None

Breast Cancer Screening

None

Prostate Cancer Screening

None

Study is for people with:

Breast Cancer

Estimated Enrollment:

539

Study ID:

NCT04317690

Recruitment Status:

Completed

Sponsor:

Massachusetts General Hospital

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There is 1 Location for this study

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Massachusetts General Hospital
Boston Massachusetts, 02114, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

539

Study ID:

NCT04317690

Recruitment Status:

Completed

Sponsor:


Massachusetts General Hospital

How clear is this clinincal trial information?

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