Evaluating the Shared Decision Making Process Scale in Cancer Screening Decisions

NCT04601272 | Completed Results

• 1 other identifier: 2005P002282
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Screening; Colon Cancer Screening; Prostate Cancer Screening

Keywords

decision making; decision aids; decision quality instruments; shared decision making; cancer screening

Outcome Measures

Primary Outcomes (1)

• Shared Decision Making Process Measure

  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.

  Baseline survey

Secondary Outcomes (6)

• The 9-item Shared Decision Making Questionnaire

  Baseline survey

• Decisional Conflict Tool (SURE)

  Baseline survey

• Single-Item Measure of Decision Regret

  Baseline survey

• Treatment Choice

  Baseline survey

• Adapted Controlled Preference Scale

  Baseline survey

Study Arms (3)

Breast Cancer Screening

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.

Behavioral: Decision aid

Colon Cancer Screening

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.

Behavioral: Decision aid

Prostate Cancer Screening

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.

Behavioral: Decision aid

Interventions

Decision aid BEHAVIORAL

Healthwise patient decision aids for breast, prostate, colon and lung cancer screening provide information on the pros and cons of cancer screening and guidance in process of selecting a choice.

Breast Cancer Screening; Colon Cancer Screening; Prostate Cancer Screening

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults who received a cancer screening decision aid in the last 2 years while receiving care at 4 hospitals within a major healthcare network.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

Decision Support Techniques

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Dr. Karen R. Sepucha
• Organization: Massachusetts General Hospital

KSEPUCHA@mgh.harvard.edu

617-724-3350

Study Officials

• Karen R Sepucha, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Health Decision Sciences Center

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 23, 2020
• Study Start: September 29, 2020
• Primary Completion: April 16, 2021
• Study Completion: June 24, 2021
• Last Updated: March 30, 2023
• Results First Posted: March 30, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The data will be made available to outside investigators starting 6 months after publication.
• Access Criteria: Information about the data sets will be on the Health Decision Sciences Center website and in publications of the data. Dr. Sepucha will share a de-identified data set with outside investigators at no cost, according to approved Massachusetts General Hospital (MGH)/ Partners policies for datasharing. Investigators from other sites will be able to request the data and will be required to complete a data use agreement that ensures that all local Institutional Review Board (IRB) requirements are met before using the data,that they will not attempt to identify any data in the dataset, and that they will not share the data set with anyone outside their project team.

Locations

US (1)