Evaluating the Shared Decision Making Process Scale in Cancer Screening Decisions

• ClinicalTrials.gov Identifier: NCT04601272
• Recruitment Status: Enrolling by invitation
• First Posted: October 23, 2020
• Last Update Posted: October 23, 2020
• Sponsor: Massachusetts General Hospital
• Collaborator: Agency for Healthcare Research and Quality (AHRQ)
• Information provided by (Responsible Party): Karen Sepucha, Massachusetts General Hospital

Study Description

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.

Condition or disease	Intervention/treatment
Breast Cancer Screening; Colon Cancer Screening; Prostate Cancer Screening; Lung Cancer Screening	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 Design

• Study Type: Observational
• Estimated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Evaluating the Performance of the Shared Decision Making Process Scale in Patients Making Cancer Screening Decisions
• Actual Study Start Date: September 29, 2020
• Estimated Primary Completion Date: February 28, 2021
• Estimated Study Completion Date: June 30, 2021

Groups and Cohorts

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.
Lung Cancer Screening; Men and Women between the ages of 50-80 when they received a decision aid for lung cancer screening with no prior diagnosis of lung cancer. These people will see items only pertaining to lung 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.

Outcome Measures

Primary Outcome Measures :

1. 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 04 where higher values indicate a better shared decision making process outcome.

Secondary Outcome Measures :

1. The 9-item Shared Decision Making Questionnaire [ Time Frame: Baseline survey ]
   The Shared Decision Making Questionnaire measure measures the amount of shared decision making that occurs in an interaction
2. Decisional Conflict Tool (SURE) [ Time Frame: Baseline survey ]
   Measures decisional conflict, consists of 4 yes/no items. Scores range 0-4 where 0 indicates extremely high decisional conflict, 0 indicates no decisional conflict, and scores less than or equal to 3 indicate decisional conflict.
3. Single-Item Measure of Decision Regret [ Time Frame: Baseline survey ]

   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

4. Treatment Choice [ Time Frame: Baseline survey ]
   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.
5. Adapted Controlled Preference Scale [ Time Frame: Baseline survey ]

   Single item asking the participants who made the ultimate decision. The categorical response options are:

   1. the patient made the decision
   2. the provider made the decision
   3. both patient and provider made the decision together.
6. Knowledge [ Time Frame: Baseline survey ]
   Multiple choice knowledge items for each topic will be combined to a total knowledge score (0-100) with higher scores indicating higher knowledge.

Eligibility Criteria

• Ages Eligible for Study: 35 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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.

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

• 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

Contacts and Locations

Locations

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Agency for Healthcare Research and Quality (AHRQ)

Investigators

• Principal Investigator: Karen R Sepucha, PhD; Massachusetts General Hospital

More Information

• Responsible Party: Karen Sepucha, Director, Health Decision Sciences Center, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT04601272
• Other Study ID Numbers: 2005P002282
• First Posted: October 23, 2020
• Last Update Posted: October 23, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The study team will create a complete, cleaned, de-identified copy of the final data set for each cancer screening topic.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Karen Sepucha, Massachusetts General Hospital:

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

Additional relevant MeSH terms:

Colonic Neoplasms; Neoplasms by Site; Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases