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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision aid | Behavioral | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Breast Cancer group
Colon Cancer Group
Prostate Cancer Group
Lung Cancer Group
Exclusion Criteria:
Breast Cancer group
Colon Cancer Group
Prostate Cancer Group
Lung Cancer Group
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Adults who received a cancer screening decision aid in the last 2 years while receiving care at 4 hospitals within a major healthcare network.
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| Name | Affiliation | Role |
|---|---|---|
| Karen R Sepucha, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
The study team will create a complete, cleaned, de-identified copy of the final data set for each cancer screening topic.
The data will be made available to outside investigators starting 6 months after publication.
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.
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Eligible patients were English speaking and fell within the appropriate age range for considering cancer screening for the clinical topic. Colon cancer group were patients between 45 and 75 years old; breast cancer group were women between 35 and 55 years old; prostate cancer group were men between 45 and 74 years old.
Eligible participants were Mass General Brigham patients who were ordered a Decision Aid between July 2018 and December 2020 for one of the 3 cancer screening topics: breast, colon, or prostate.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. 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. |
| FG002 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who received a decision aid for breast/colon/prostate cancer within the last 2 years. Participants provided enough information to calculate the shared decision making process score (primary outcome of interest)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | participants who provided enough information to calculate a shared decision making process score (primary outcome of interest). 233/233 patients provided an answer to this question. | Posted | Mean | Standard Deviation | score on a scale | Baseline survey |
|
The surveys were reviewed within 2 weeks as they came in for evidence of adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen R. Sepucha | Massachusetts General Hospital | 617-724-3350 | KSEPUCHA@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 30, 2021 | Mar 1, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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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:
| 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 |
| BG001 | 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. 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. |
| BG002 | 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. 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. 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. |
| OG002 | 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. 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. |
|
|
| 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. | participants who answered at least 2 out of 9 of the 9-item shared decision making questionnaire. Only 223/233 participants provided sufficient information to calculate a SDMQ9 score. | Posted | Mean | Standard Deviation | score on a scale | 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. | participants who answered all 4 items of the decisional conflict scale. Only 217/233 provided sufficient information to calculate a SURE score. | Posted | Number | percentage of participants | 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 | Participants who answered the single-item regret question. Only 220/233 participants provided sufficient information to calculate regret. | Posted | Count of Participants | Participants | 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. | Participants who answered the question asking their treatment preference. Only 231/233 provided sufficient information for this question. | Posted | Count of Participants | Participants | Baseline survey |
|
|
|
| Secondary | Adapted Controlled Preference Scale | Single item asking the participants who made the ultimate decision. The categorical response options are:
| participants who answered the adapted controlled preference question. Only 220/233 participants provided sufficient information to calculate preference. | Posted | Count of Participants | Participants | 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. | participants who completed at least 60% of the knowledge questions for their respective cancer screening group. Only 225/233 participants provided sufficient information to calculate a knowledge score. | Posted | Mean | Standard Deviation | percentage of correct answers | Baseline survey |
|
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|
| 0 |
| 71 |
| 0 |
| 71 |
| 0 |
| 71 |
| EG001 | 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. 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. | 0 | 86 | 0 | 86 | 0 | 86 |
| EG002 | 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. 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. | 0 | 76 | 0 | 76 | 0 | 76 |
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| Probably no |
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| Definitely no |
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| Wait until 50 |
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| Have a colonoscopy |
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| Do a stool-based test |
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| No screening |
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| Have a PSA test |
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| Not have a PSA test |
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| Do something else |
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| Unsure |
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| We made the decision together |
|