Evaluating the Shared Decision Making Process Scale in Cancer Screening Decisions

Breast Cancer Screening Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04601272
• Other study ID #: 2005P002282
• Status: Completed
• Start date: September 29, 2020
• Est. completion date: June 24, 2021

Study information

• Verified date: June 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: June 24, 2021
• Est. primary completion date: April 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Screening
• Colon Cancer Screening
• Colonic Neoplasms
• Prostate Cancer Screening

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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