An observational study in Breast Cancer Screening, Colon Cancer Screening and Prostate Cancer Screening, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 35 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-30.
Sponsored by Massachusetts General Hospital · Observational
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.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's enrollment of 240 is below the median of 280 across 349 observational studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
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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.
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
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
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
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.
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.
Time frame: Baseline survey
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Baseline survey
Adapted Controlled Preference Scale
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.
Time frame: 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.
Time frame: Baseline survey
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.
| Milestone | Breast Cancer Screening | Colon Cancer Screening | Prostate Cancer Screening |
|---|---|---|---|
| Started | 73 | 89 | 78 |
| Completed | 71 | 86 | 76 |
| Not completed | 2 | 3 | 2 |
| Withdrew: Did not have sufficient information to calculate the sdm process score (primary outcome) | 2 | 3 | 2 |
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.
| score on a scale | Breast Cancer Screening | Colon Cancer Screening | Prostate Cancer Screening |
|---|---|---|---|
| Shared Decision Making Process Measure | 1.05 ± 1.07 | 1.20 ± 1.10 | 2.10 ± 0.90 |
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.
| score on a scale | Breast Cancer Screening | Colon Cancer Screening | Prostate Cancer Screening |
|---|---|---|---|
| The 9-item Shared Decision Making Questionnaire | 50.5 ± 25.6 | 56.8 ± 27.9 | 63.8 ± 22.9 |
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.
| percentage of participants | Breast Cancer Screening | Colon Cancer Screening | Prostate Cancer Screening |
|---|---|---|---|
| Decisional Conflict Tool (SURE) | 49 | 51 | 67 |
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 | Breast Cancer Screening | Colon Cancer Screening | Prostate Cancer Screening |
|---|---|---|---|
| Definitely yes | 33 | 44 | 33 |
| Probably yes | 27 | 32 | 32 |
| Probably no | 3 | 6 | 6 |
| Definitely no | 2 | 2 | 0 |
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 | Breast Cancer Screening | Colon Cancer Screening | Prostate Cancer Screening |
|---|---|---|---|
| Start mammograms in 40s | 39 | NA | NA |
| Wait until 50 | 8 | NA | NA |
| Have a colonoscopy | NA | 45 | NA |
| Do a stool-based test | NA | 24 | NA |
| No screening | NA | 1 | NA |
| Have a PSA test | NA | NA | 42 |
| Not have a PSA test | NA | NA | 20 |
| Do something else | 10 | 8 | 1 |
| Unsure | 14 | 8 | 11 |
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.
| Participants | Breast Cancer Screening | Colon Cancer Screening | Prostate Cancer Screening |
|---|---|---|---|
| Mainly my decision | 33 | 33 | 45 |
| Mainly the healthcare providers decision | 10 | 19 | 5 |
| We made the decision together | 23 | 30 | 22 |
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.
| percentage of correct answers | Breast Cancer Screening | Colon Cancer Screening | Prostate Cancer Screening |
|---|---|---|---|
| Knowledge | 43 ± 21 | 58 ± 19 | 62 ± 24 |
Collected over The surveys were reviewed within 2 weeks as they came in for evidence of adverse events.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Breast Cancer Screening | 0/71 (0%) | 0/71 (0%) | 0/71 (0%) |
| Colon Cancer Screening | 0/86 (0%) | 0/86 (0%) | 0/86 (0%) |
| Prostate Cancer Screening | 0/76 (0%) | 0/76 (0%) | 0/76 (0%) |
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)
| Age, Continuous(years) | Breast Cancer Screening | Colon Cancer Screening | Prostate Cancer Screening | Total |
|---|---|---|---|---|
| Mean | 43 ± 4 | 60 ± 9 | 59 ± 8 | 55 ± 11 |
| Sex: Female, Male(Participants) | Breast Cancer Screening | Colon Cancer Screening | Prostate Cancer Screening | Total |
|---|---|---|---|---|
| Female | 71 | 60 | 76 | 207 |
| Male | 0 | 26 | 0 | 26 |
| Ethnicity (NIH/OMB)(Participants) | Breast Cancer Screening | Colon Cancer Screening | Prostate Cancer Screening | Total |
|---|---|---|---|---|
| Hispanic or Latino | 3 | 3 | 2 | 8 |
| Not Hispanic or Latino | 67 | 56 | 71 | 194 |
| Unknown or Not Reported | 1 | 27 | 3 | 31 |
| Race (NIH/OMB)(Participants) | Breast Cancer Screening | Colon Cancer Screening | Prostate Cancer Screening | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 13 | 5 | 4 | 22 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 5 | 1 | 2 | 8 |
| White | 48 | 73 | 66 | 187 |
| More than one race | 2 | 3 | 0 | 5 |
| Unknown or Not Reported | 3 | 4 | 4 | 11 |
| Region of Enrollment(participants) | Breast Cancer Screening | Colon Cancer Screening | Prostate Cancer Screening | Total |
|---|---|---|---|---|
| United States | 71 | 86 | 76 | 334 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The study team will create a complete, cleaned, de-identified copy of the final data set for each cancer screening topic.
Supporting information: Study protocol, Sap, Analytic code
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital