Trial Outcomes & Findings for Evaluating the Shared Decision Making Process Scale in Cancer Screening Decisions (NCT NCT04601272)
NCT ID: NCT04601272
Last Updated: 2023-03-30
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
240 participants
Primary outcome timeframe
Baseline survey
Results posted on
2023-03-30
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
73
|
89
|
78
|
|
Overall Study
COMPLETED
|
71
|
86
|
76
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
did not have sufficient information to calculate the SDM Process score (primary outcome)
|
2
|
3
|
2
|
Baseline Characteristics
Evaluating the Shared Decision Making Process Scale in Cancer Screening Decisions
Baseline characteristics by cohort
| Measure |
Breast Cancer Screening
n=71 Participants
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.
|
Colon Cancer Screening
n=86 Participants
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.
|
Prostate Cancer Screening
n=76 Participants
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.
|
Total
n=233 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 4 • n=93 Participants
|
60 years
STANDARD_DEVIATION 9 • n=4 Participants
|
59 years
STANDARD_DEVIATION 8 • n=27 Participants
|
55 years
STANDARD_DEVIATION 11 • n=483 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=93 Participants
|
60 Participants
n=4 Participants
|
76 Participants
n=27 Participants
|
207 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
26 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=93 Participants
|
56 Participants
n=4 Participants
|
71 Participants
n=27 Participants
|
194 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
31 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
22 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=93 Participants
|
73 Participants
n=4 Participants
|
66 Participants
n=27 Participants
|
187 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
71 participants
n=93 Participants
|
86 participants
n=4 Participants
|
76 participants
n=27 Participants
|
334 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline surveyPopulation: 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.
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.
Outcome measures
| Measure |
Breast Cancer Screening
n=71 Participants
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.
|
Colon Cancer Screening
n=86 Participants
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.
|
Prostate Cancer Screening
n=76 Participants
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.
|
|---|---|---|---|
|
Shared Decision Making Process Measure
|
1.05 score on a scale
Standard Deviation 1.07
|
1.20 score on a scale
Standard Deviation 1.10
|
2.10 score on a scale
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: Baseline surveyPopulation: 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.
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.
Outcome measures
| Measure |
Breast Cancer Screening
n=69 Participants
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.
|
Colon Cancer Screening
n=82 Participants
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.
|
Prostate Cancer Screening
n=72 Participants
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.
|
|---|---|---|---|
|
The 9-item Shared Decision Making Questionnaire
|
50.5 score on a scale
Standard Deviation 25.6
|
56.8 score on a scale
Standard Deviation 27.9
|
63.8 score on a scale
Standard Deviation 22.9
|
SECONDARY outcome
Timeframe: Baseline surveyPopulation: participants who answered all 4 items of the decisional conflict scale. Only 217/233 provided sufficient information to calculate a SURE score.
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.
Outcome measures
| Measure |
Breast Cancer Screening
n=69 Participants
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.
|
Colon Cancer Screening
n=78 Participants
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.
|
Prostate Cancer Screening
n=70 Participants
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.
|
|---|---|---|---|
|
Decisional Conflict Tool (SURE)
|
49 percentage of participants
|
51 percentage of participants
|
67 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline surveyPopulation: Participants who answered the single-item regret question. Only 220/233 participants provided sufficient information to calculate 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
Outcome measures
| Measure |
Breast Cancer Screening
n=65 Participants
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.
|
Colon Cancer Screening
n=84 Participants
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.
|
Prostate Cancer Screening
n=71 Participants
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.
|
|---|---|---|---|
|
Single-Item Measure of Decision Regret
Definitely yes
|
33 Participants
|
44 Participants
|
33 Participants
|
|
Single-Item Measure of Decision Regret
Probably yes
|
27 Participants
|
32 Participants
|
32 Participants
|
|
Single-Item Measure of Decision Regret
Probably no
|
3 Participants
|
6 Participants
|
6 Participants
|
|
Single-Item Measure of Decision Regret
Definitely no
|
2 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline surveyPopulation: Participants who answered the question asking their treatment preference. Only 231/233 provided sufficient information for this question.
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.
Outcome measures
| Measure |
Breast Cancer Screening
n=71 Participants
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.
|
Colon Cancer Screening
n=86 Participants
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.
|
Prostate Cancer Screening
n=74 Participants
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.
|
|---|---|---|---|
|
Treatment Choice
No screening
|
NA Participants
response option only administered to colon cancer screening group
|
1 Participants
|
NA Participants
response option only administered to colon cancer screening group
|
|
Treatment Choice
Start mammograms in 40s
|
39 Participants
|
NA Participants
response option only administered to breast cancer screening group
|
NA Participants
response option only administered to breast cancer screening group
|
|
Treatment Choice
Wait until 50
|
8 Participants
|
NA Participants
response option only administered to breast cancer screening group
|
NA Participants
response option only administered to breast cancer screening group
|
|
Treatment Choice
Have a colonoscopy
|
NA Participants
response option only administered to colon cancer screening group
|
45 Participants
|
NA Participants
response option only administered to colon cancer screening group
|
|
Treatment Choice
Do a stool-based test
|
NA Participants
response option only administered to colon cancer screening group
|
24 Participants
|
NA Participants
response option only administered to colon cancer screening group
|
|
Treatment Choice
Have a PSA test
|
NA Participants
response option only administered to prostate cancer screening group
|
NA Participants
response option only administered to prostate cancer screening group
|
42 Participants
|
|
Treatment Choice
Not have a PSA test
|
NA Participants
response option only administered to prostate cancer screening group
|
NA Participants
response option only administered to prostate cancer screening group
|
20 Participants
|
|
Treatment Choice
Do something else
|
10 Participants
|
8 Participants
|
1 Participants
|
|
Treatment Choice
Unsure
|
14 Participants
|
8 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Baseline surveyPopulation: participants who answered the adapted controlled preference question. Only 220/233 participants provided sufficient information to calculate preference.
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.
Outcome measures
| Measure |
Breast Cancer Screening
n=66 Participants
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.
|
Colon Cancer Screening
n=82 Participants
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.
|
Prostate Cancer Screening
n=72 Participants
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.
|
|---|---|---|---|
|
Adapted Controlled Preference Scale
Mainly my decision
|
33 Participants
|
33 Participants
|
45 Participants
|
|
Adapted Controlled Preference Scale
Mainly the healthcare providers decision
|
10 Participants
|
19 Participants
|
5 Participants
|
|
Adapted Controlled Preference Scale
We made the decision together
|
23 Participants
|
30 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Baseline surveyPopulation: 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.
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.
Outcome measures
| Measure |
Breast Cancer Screening
n=71 Participants
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.
|
Colon Cancer Screening
n=84 Participants
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.
|
Prostate Cancer Screening
n=70 Participants
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.
|
|---|---|---|---|
|
Knowledge
|
43 percentage of correct answers
Standard Deviation 21
|
58 percentage of correct answers
Standard Deviation 19
|
62 percentage of correct answers
Standard Deviation 24
|
Adverse Events
Breast Cancer Screening
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Colon Cancer Screening
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Prostate Cancer Screening
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place