Evaluating the Shared Decision Making Process Scale in Cancer Screening Decisions

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer Screening, Colon Cancer Screening, Prostate Cancer Screening

Intervention / Treatment
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* Behavioral: Decision aid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast Cancer Screening<br>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<br>* 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.<br>|
| Colon Cancer Screening<br>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<br>* 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.<br>|
| Prostate Cancer Screening<br>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<br>* 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.<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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decision making, decision aids, decision quality instruments, shared decision making, cancer screening