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Evaluating the Shared Decision Making Process Scale in Cancer Screening Decisions

Mass General Brigham logo

Mass General Brigham

Status

Completed

Conditions

Prostate Cancer Screening
Breast Cancer Screening
Colon Cancer Screening

Treatments

Behavioral: Decision aid

Study type

Observational

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT04601272
2005P002282

Details and patient eligibility

About

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.

Full 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.

Enrollment

240 patients

Sex

All

Ages

35 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

  • Male sex
  • 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

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
  • 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

Trial design

240 participants in 3 patient groups

Breast Cancer Screening
Description:
Women between the ages of 35-55 when they received a decision aid for breast cancer screening with no prior diagnosis of breast cancer. These people will see items only pertaining to breast cancer screening.
Treatment:
Behavioral: Decision aid
Colon Cancer Screening
Description:
Men and women between the ages of 45-75 when they received a decision aid for colon cancer screening with no prior diagnosis of colon cancer. These people will see items only pertaining to colon cancer screening.
Treatment:
Behavioral: Decision aid
Prostate Cancer Screening
Description:
Men between the ages of 45-74 when they received a decision aid for prostate cancer screening with no prior diagnosis of prostate cancer. These people will see items only pertaining to prostate cancer screening.
Treatment:
Behavioral: Decision aid

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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