Breast Cancer Screening, Colon Cancer Screening, Prostate Cancer Screening
Conditions
Keywords
decision making, decision aids, decision quality instruments, shared decision making, cancer screening
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.
Interventions
BEHAVIORALDecision 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.
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
Massachusetts General Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 71 |
| 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. | 86 |
| 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. | 76 |
| Total | 233 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | did not have sufficient information to calculate the SDM Process score (primary outcome) | 2 | 3 | 2 |
Baseline characteristics
| Characteristic | Breast Cancer Screening | Total | Prostate Cancer Screening | Colon Cancer Screening |
|---|---|---|---|---|
| Age, Continuous | 43 years STANDARD_DEVIATION 4 | 55 years STANDARD_DEVIATION 11 | 59 years STANDARD_DEVIATION 8 | 60 years STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 8 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 67 Participants | 194 Participants | 71 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 31 Participants | 3 Participants | 27 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 22 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 8 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 5 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 11 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) White | 48 Participants | 187 Participants | 66 Participants | 73 Participants |
| Region of Enrollment United States | 71 participants | 334 participants | 76 participants | 86 participants |
| Sex: Female, Male Female | 71 Participants | 207 Participants | 76 Participants | 60 Participants |
| Sex: Female, Male Male | 0 Participants | 26 Participants | 0 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 71 | 0 / 86 | 0 / 76 |
| other Total, other adverse events | 0 / 71 | 0 / 86 | 0 / 76 |
| serious Total, serious adverse events | 0 / 71 | 0 / 86 | 0 / 76 |
Outcome results
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.
Time frame: Baseline survey
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breast Cancer Screening | Shared Decision Making Process Measure | 1.05 score on a scale | Standard Deviation 1.07 |
| Colon Cancer Screening | Shared Decision Making Process Measure | 1.20 score on a scale | Standard Deviation 1.1 |
| Prostate Cancer Screening | Shared Decision Making Process Measure | 2.10 score on a scale | Standard Deviation 0.9 |
Secondary
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
Population: participants who answered the adapted controlled preference question. Only 220/233 participants provided sufficient information to calculate preference.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Breast Cancer Screening | Adapted Controlled Preference Scale | Mainly the healthcare providers decision | 10 Participants |
| Breast Cancer Screening | Adapted Controlled Preference Scale | Mainly my decision | 33 Participants |
| Breast Cancer Screening | Adapted Controlled Preference Scale | We made the decision together | 23 Participants |
| Colon Cancer Screening | Adapted Controlled Preference Scale | Mainly the healthcare providers decision | 19 Participants |
| Colon Cancer Screening | Adapted Controlled Preference Scale | Mainly my decision | 33 Participants |
| Colon Cancer Screening | Adapted Controlled Preference Scale | We made the decision together | 30 Participants |
| Prostate Cancer Screening | Adapted Controlled Preference Scale | Mainly my decision | 45 Participants |
| Prostate Cancer Screening | Adapted Controlled Preference Scale | We made the decision together | 22 Participants |
| Prostate Cancer Screening | Adapted Controlled Preference Scale | Mainly the healthcare providers decision | 5 Participants |
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.
Time frame: Baseline survey
Population: participants who answered all 4 items of the decisional conflict scale. Only 217/233 provided sufficient information to calculate a SURE score.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Breast Cancer Screening | Decisional Conflict Tool (SURE) | 49 percentage of participants |
| Colon Cancer Screening | Decisional Conflict Tool (SURE) | 51 percentage of participants |
| Prostate Cancer Screening | Decisional Conflict Tool (SURE) | 67 percentage of participants |
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.
Time frame: Baseline survey
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breast Cancer Screening | Knowledge | 43 percentage of correct answers | Standard Deviation 21 |
| Colon Cancer Screening | Knowledge | 58 percentage of correct answers | Standard Deviation 19 |
| Prostate Cancer Screening | Knowledge | 62 percentage of correct answers | Standard Deviation 24 |
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
Time frame: Baseline survey
Population: Participants who answered the single-item regret question. Only 220/233 participants provided sufficient information to calculate regret.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Breast Cancer Screening | Single-Item Measure of Decision Regret | Definitely yes | 33 Participants |
| Breast Cancer Screening | Single-Item Measure of Decision Regret | Probably yes | 27 Participants |
| Breast Cancer Screening | Single-Item Measure of Decision Regret | Probably no | 3 Participants |
| Breast Cancer Screening | Single-Item Measure of Decision Regret | Definitely no | 2 Participants |
| Colon Cancer Screening | Single-Item Measure of Decision Regret | Definitely no | 2 Participants |
| Colon Cancer Screening | Single-Item Measure of Decision Regret | Definitely yes | 44 Participants |
| Colon Cancer Screening | Single-Item Measure of Decision Regret | Probably no | 6 Participants |
| Colon Cancer Screening | Single-Item Measure of Decision Regret | Probably yes | 32 Participants |
| Prostate Cancer Screening | Single-Item Measure of Decision Regret | Definitely no | 0 Participants |
| Prostate Cancer Screening | Single-Item Measure of Decision Regret | Probably yes | 32 Participants |
| Prostate Cancer Screening | Single-Item Measure of Decision Regret | Probably no | 6 Participants |
| Prostate Cancer Screening | Single-Item Measure of Decision Regret | Definitely yes | 33 Participants |
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.
Time frame: Baseline survey
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breast Cancer Screening | The 9-item Shared Decision Making Questionnaire | 50.5 score on a scale | Standard Deviation 25.6 |
| Colon Cancer Screening | The 9-item Shared Decision Making Questionnaire | 56.8 score on a scale | Standard Deviation 27.9 |
| Prostate Cancer Screening | The 9-item Shared Decision Making Questionnaire | 63.8 score on a scale | Standard Deviation 22.9 |
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.
Time frame: Baseline survey
Population: Participants who answered the question asking their treatment preference. Only 231/233 provided sufficient information for this question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Breast Cancer Screening | Treatment Choice | Start mammograms in 40s | 39 Participants |
| Breast Cancer Screening | Treatment Choice | Wait until 50 | 8 Participants |
| Breast Cancer Screening | Treatment Choice | Have a colonoscopy | NA Participants |
| Breast Cancer Screening | Treatment Choice | Do a stool-based test | NA Participants |
| Breast Cancer Screening | Treatment Choice | No screening | NA Participants |
| Breast Cancer Screening | Treatment Choice | Have a PSA test | NA Participants |
| Breast Cancer Screening | Treatment Choice | Not have a PSA test | NA Participants |
| Breast Cancer Screening | Treatment Choice | Do something else | 10 Participants |
| Breast Cancer Screening | Treatment Choice | Unsure | 14 Participants |
| Colon Cancer Screening | Treatment Choice | No screening | 1 Participants |
| Colon Cancer Screening | Treatment Choice | Do something else | 8 Participants |
| Colon Cancer Screening | Treatment Choice | Do a stool-based test | 24 Participants |
| Colon Cancer Screening | Treatment Choice | Wait until 50 | NA Participants |
| Colon Cancer Screening | Treatment Choice | Unsure | 8 Participants |
| Colon Cancer Screening | Treatment Choice | Not have a PSA test | NA Participants |
| Colon Cancer Screening | Treatment Choice | Have a PSA test | NA Participants |
| Colon Cancer Screening | Treatment Choice | Start mammograms in 40s | NA Participants |
| Colon Cancer Screening | Treatment Choice | Have a colonoscopy | 45 Participants |
| Prostate Cancer Screening | Treatment Choice | Have a PSA test | 42 Participants |
| Prostate Cancer Screening | Treatment Choice | Not have a PSA test | 20 Participants |
| Prostate Cancer Screening | Treatment Choice | Do a stool-based test | NA Participants |
| Prostate Cancer Screening | Treatment Choice | No screening | NA Participants |
| Prostate Cancer Screening | Treatment Choice | Do something else | 1 Participants |
| Prostate Cancer Screening | Treatment Choice | Have a colonoscopy | NA Participants |
| Prostate Cancer Screening | Treatment Choice | Unsure | 11 Participants |
| Prostate Cancer Screening | Treatment Choice | Wait until 50 | NA Participants |
| Prostate Cancer Screening | Treatment Choice | Start mammograms in 40s | NA Participants |