Evaluating the Shared Decision Making Process Scale in Cancer Screening Decisions

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Screening; Colon Cancer Screening; Prostate Cancer Screening
• Intervention / Treatment: Behavioral: Decision aid

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.

• Study Type: Observational
• Enrollment (Actual): 240

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Single-Item Measure of Decision Regret	Single item asking "If you knew then what you know now, do you think you would make the same decision about [breast cancer screening/colon cancer screening/ prostate cancer screening/lung cancer screening]?" where the last part varies by group. Response options are: Definitely yes, Probably yes, Probably No, Definitely No	Baseline survey
Treatment Choice	Single item asking patient "What did you want to do" in regard to (depending on the group) colon cancer screening/ breast cancer screening/ prostate cancer screening/ lung cancer screening.	Baseline survey
Adapted Controlled Preference Scale	Single item asking the participants who made the ultimate decision. The categorical response options are: the patient made the decision; the provider made the decision; both patient and provider made the decision together.	Baseline survey
The 9-item Shared Decision Making Questionnaire	The Shared Decision Making Questionnaire measure measures the amount of shared decision making that occurs in an interaction. Scores range from 0-100 where higher values indicate a better shared decision making process occurred.	Baseline survey
Decisional Conflict Tool (SURE)	Measures decisional conflict, consists of 4 yes/no items. Scores range 0-4 where 0 indicates extremely high decisional conflict, 4 indicates no decisional conflict. The number who get score of 4 is reported indicating no decisional conflict.	Baseline survey
Knowledge	Multiple choice knowledge items specific for each topic will be combined to a total knowledge score (0-100) with higher scores indicating higher knowledge. These items are part of the knowledge subscale in the published Decision Quality Instruments.	Baseline survey

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2020
• Primary Completion (Actual): April 16, 2021
• Study Completion (Actual): June 24, 2021

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 23, 2020

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: shared decision making; decision making; decision aids; cancer screening; decision quality instruments
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: 2005P002282

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study team will create a complete, cleaned, de-identified copy of the final data set for each cancer screening topic.
• IPD Sharing Time Frame: The data will be made available to outside investigators starting 6 months after publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No