Evaluating the Shared Decision Making Process Scale in Cancer Screening Decisions

Completed

Conditions: Breast Cancer Screening
Colon Cancer Screening
Prostate Cancer Screening

Interventions: Behavioral: Decision aid

Registration Number: NCT04601272

Lead Sponsor: Massachusetts General Hospital

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 240

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prostate Cancer Screening	Decision aid	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.
Colon Cancer Screening	Decision aid	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.
Breast Cancer Screening	Decision aid	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.

Primary Outcome Measures

Name	Time	Method
Shared Decision Making Process Measure	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 0-4 where higher values indicate a better shared decision making process outcome.

Secondary Outcome Measures

Name	Time	Method
Knowledge	Baseline survey	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.
Adapted Controlled Preference Scale	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.
The 9-item Shared Decision Making Questionnaire	Baseline survey	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.
Treatment Choice	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.
Decisional Conflict Tool (SURE)	Baseline survey	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.
Single-Item Measure of Decision Regret	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