Trial Outcomes & Findings for Online Trial Examining Validity and Reliability of the Shared Decision Making Process Survey (NCT NCT04317690)

NCT ID: NCT04317690

Last Updated: 2022-05-20

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 occurred.

Recruitment status

COMPLETED

Target enrollment

539 participants

Primary outcome timeframe

Baseline survey

Results posted on

2022-05-20

Participant Flow

March 2020 - July 2020 using a national, non-probability panel obtained from Marketing Systems Group (MSG). MSG recruited participants by sending out invitation emails to potential responders.

Eligible respondents were adults in the US who had talked with a healthcare provider about screening for cancer (breast, colon, or prostate) or taking medication for a common chronic condition (depression, high cholesterol, or high blood pressure) in the past two years. Respondents were re-contacted approximately one-week post survey for a re-test survey.

Participant milestones

Participant milestones
Measure
High Cholesterol
People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high cholesterol, who are either taking medication for high cholesterol for 2 years or less; or have discussed managing high cholesterol in the past 2 years. These people will see items only pertaining to high cholesterol.
High Blood Pressure
People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high blood pressure, who are either taking medication for high blood pressure for 2 years or less; or have discussed managing high blood pressure in the past 2 years. These people will see items only pertaining to high blood pressure.
Colorectal Cancer Screening
People between the ages of 50-75 with no previous diagnosis of colon cancer, who have been screened for colon cancer (or discussed screening for colon cancer) in the past 2 years, or who had first colon cancer screening in past 2 years. These people will see items only pertaining to colon cancer screening.
Breast Cancer Screening
Females between the ages of 40-50 with no previous diagnosis of breast cancer who have had mammogram (or discussed having a mammogram) in the past 2 years, or had first mammogram in past 2 years. These people will see items only pertaining to breast cancer screening.
Prostate Cancer Screening
Men between the ages of 45-69 with no previous diagnosis of prostate cancer who have been screened for prostate cancer (or discussed screening for prostate cancer) in the past 2 years or had first prostate cancer screening in the past 2 years. These people will see items only pertaining to prostate cancer screening.
Overall Study
STARTED
100
100
140
100
99
Overall Study
COMPLETED
100
96
140
98
99
Overall Study
NOT COMPLETED
0
4
0
2
0

Reasons for withdrawal

Reasons for withdrawal
Measure
High Cholesterol
People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high cholesterol, who are either taking medication for high cholesterol for 2 years or less; or have discussed managing high cholesterol in the past 2 years. These people will see items only pertaining to high cholesterol.
High Blood Pressure
People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high blood pressure, who are either taking medication for high blood pressure for 2 years or less; or have discussed managing high blood pressure in the past 2 years. These people will see items only pertaining to high blood pressure.
Colorectal Cancer Screening
People between the ages of 50-75 with no previous diagnosis of colon cancer, who have been screened for colon cancer (or discussed screening for colon cancer) in the past 2 years, or who had first colon cancer screening in past 2 years. These people will see items only pertaining to colon cancer screening.
Breast Cancer Screening
Females between the ages of 40-50 with no previous diagnosis of breast cancer who have had mammogram (or discussed having a mammogram) in the past 2 years, or had first mammogram in past 2 years. These people will see items only pertaining to breast cancer screening.
Prostate Cancer Screening
Men between the ages of 45-69 with no previous diagnosis of prostate cancer who have been screened for prostate cancer (or discussed screening for prostate cancer) in the past 2 years or had first prostate cancer screening in the past 2 years. These people will see items only pertaining to prostate cancer screening.
Overall Study
did not have complete information for primary outcome
0
4
0
2
0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
High Cholesterol
n=100 Participants
People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high cholesterol, who are either taking medication for high cholesterol for 2 years or less; or have discussed managing high cholesterol in the past 2 years. These people will see items only pertaining to high cholesterol.
High Blood Pressure
n=96 Participants
People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high blood pressure, who are either taking medication for high blood pressure for 2 years or less; or have discussed managing high blood pressure in the past 2 years. These people will see items only pertaining to high blood pressure.
Colorectal Cancer Screening
n=140 Participants
People between the ages of 50-75 with no previous diagnosis of colon cancer, who have been screened for colon cancer (or discussed screening for colon cancer) in the past 2 years, or who had first colon cancer screening in past 2 years. These people will see items only pertaining to colon cancer screening.
Breast Cancer Screening
n=98 Participants
Females between the ages of 40-50 with no previous diagnosis of breast cancer who have had mammogram (or discussed having a mammogram) in the past 2 years, or had first mammogram in past 2 years. These people will see items only pertaining to breast cancer screening.
Prostate Cancer Screening
n=99 Participants
Men between the ages of 45-69 with no previous diagnosis of prostate cancer who have been screened for prostate cancer (or discussed screening for prostate cancer) in the past 2 years or had first prostate cancer screening in the past 2 years. These people will see items only pertaining to prostate cancer screening.
Total
n=533 Participants
Total of all reporting groups
Age, Continuous
52 years
STANDARD_DEVIATION 12 • n=100 Participants
43 years
STANDARD_DEVIATION 11 • n=96 Participants
61 years
STANDARD_DEVIATION 7 • n=140 Participants
44 years
STANDARD_DEVIATION 3 • n=98 Participants
52 years
STANDARD_DEVIATION 4 • n=99 Participants
52 years
STANDARD_DEVIATION 11 • n=533 Participants
Sex: Female, Male
Female
63 Participants
n=100 Participants
41 Participants
n=96 Participants
43 Participants
n=140 Participants
98 Participants
n=98 Participants
0 Participants
n=99 Participants
245 Participants
n=533 Participants
Sex: Female, Male
Male
37 Participants
n=100 Participants
55 Participants
n=96 Participants
97 Participants
n=140 Participants
0 Participants
n=98 Participants
99 Participants
n=99 Participants
288 Participants
n=533 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
10 Participants
n=100 Participants
11 Participants
n=96 Participants
10 Participants
n=140 Participants
8 Participants
n=98 Participants
6 Participants
n=99 Participants
45 Participants
n=533 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
90 Participants
n=100 Participants
85 Participants
n=96 Participants
130 Participants
n=140 Participants
90 Participants
n=98 Participants
93 Participants
n=99 Participants
488 Participants
n=533 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=100 Participants
0 Participants
n=96 Participants
0 Participants
n=140 Participants
0 Participants
n=98 Participants
0 Participants
n=99 Participants
0 Participants
n=533 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=100 Participants
1 Participants
n=96 Participants
1 Participants
n=140 Participants
0 Participants
n=98 Participants
1 Participants
n=99 Participants
3 Participants
n=533 Participants
Race (NIH/OMB)
Asian
4 Participants
n=100 Participants
2 Participants
n=96 Participants
4 Participants
n=140 Participants
7 Participants
n=98 Participants
0 Participants
n=99 Participants
17 Participants
n=533 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=100 Participants
0 Participants
n=96 Participants
0 Participants
n=140 Participants
0 Participants
n=98 Participants
0 Participants
n=99 Participants
0 Participants
n=533 Participants
Race (NIH/OMB)
Black or African American
8 Participants
n=100 Participants
11 Participants
n=96 Participants
16 Participants
n=140 Participants
9 Participants
n=98 Participants
17 Participants
n=99 Participants
61 Participants
n=533 Participants
Race (NIH/OMB)
White
78 Participants
n=100 Participants
74 Participants
n=96 Participants
112 Participants
n=140 Participants
75 Participants
n=98 Participants
75 Participants
n=99 Participants
414 Participants
n=533 Participants
Race (NIH/OMB)
More than one race
3 Participants
n=100 Participants
4 Participants
n=96 Participants
2 Participants
n=140 Participants
2 Participants
n=98 Participants
1 Participants
n=99 Participants
12 Participants
n=533 Participants
Race (NIH/OMB)
Unknown or Not Reported
7 Participants
n=100 Participants
4 Participants
n=96 Participants
5 Participants
n=140 Participants
5 Participants
n=98 Participants
5 Participants
n=99 Participants
26 Participants
n=533 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Baseline survey

Population: participants who provided complete information to calculate a shared decision making process score (primary outcome of interest)

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 occurred.

Outcome measures

Outcome measures
Measure
Colorectal Cancer Screening
n=140 Participants
People between the ages of 50-75 with no previous diagnosis of colon cancer, who have been screened for colon cancer (or discussed screening for colon cancer) in the past 2 years, or who had first colon cancer screening in past 2 years. These people will see items only pertaining to colon cancer screening.
Breast Cancer Screening
n=98 Participants
Females between the ages of 40-50 with no previous diagnosis of breast cancer who have had mammogram (or discussed having a mammogram) in the past 2 years, or had first mammogram in past 2 years. These people will see items only pertaining to breast cancer screening.
Prostate Cancer Screening
n=99 Participants
Men between the ages of 45-69 with no previous diagnosis of prostate cancer who have been screened for prostate cancer (or discussed screening for prostate cancer) in the past 2 years or had first prostate cancer screening in the past 2 years. These people will see items only pertaining to prostate cancer screening.
High Cholesterol
n=100 Participants
People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high cholesterol, who are either taking medication for high cholesterol for 2 years or less; or have discussed managing high cholesterol in the past 2 years. These people will see items only pertaining to high cholesterol.
High Blood Pressure
n=96 Participants
People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high blood pressure, who are either taking medication for high blood pressure for 2 years or less; or have discussed managing high blood pressure in the past 2 years. These people will see items only pertaining to high blood pressure.
Shared Decision Making Process Measure
1.61 score on a scale
Standard Deviation 1.12
1.4 score on a scale
Standard Deviation 1.1
1.87 score on a scale
Standard Deviation 0.97
2.12 score on a scale
Standard Deviation 1.03
2.65 score on a scale
Standard Deviation 1.04

SECONDARY outcome

Timeframe: Baseline survey

Population: participants who completed all 4 items of the short decisional conflict scale. Only 532/533 participants provided enough information to calculate a SURE score.

Measures decisional conflict, consists of 4 yes/no items. Scores range 0-4 where 0 indicates no decisional conflict, and scores 1 to 3 indicate decisional conflict. The measure is often reported as a top-score of 0, thus the percentage of patients with a total score of 0 or no decisional conflict.

Outcome measures

Outcome measures
Measure
Colorectal Cancer Screening
n=139 Participants
People between the ages of 50-75 with no previous diagnosis of colon cancer, who have been screened for colon cancer (or discussed screening for colon cancer) in the past 2 years, or who had first colon cancer screening in past 2 years. These people will see items only pertaining to colon cancer screening.
Breast Cancer Screening
n=98 Participants
Females between the ages of 40-50 with no previous diagnosis of breast cancer who have had mammogram (or discussed having a mammogram) in the past 2 years, or had first mammogram in past 2 years. These people will see items only pertaining to breast cancer screening.
Prostate Cancer Screening
n=99 Participants
Men between the ages of 45-69 with no previous diagnosis of prostate cancer who have been screened for prostate cancer (or discussed screening for prostate cancer) in the past 2 years or had first prostate cancer screening in the past 2 years. These people will see items only pertaining to prostate cancer screening.
High Cholesterol
n=100 Participants
People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high cholesterol, who are either taking medication for high cholesterol for 2 years or less; or have discussed managing high cholesterol in the past 2 years. These people will see items only pertaining to high cholesterol.
High Blood Pressure
n=96 Participants
People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high blood pressure, who are either taking medication for high blood pressure for 2 years or less; or have discussed managing high blood pressure in the past 2 years. These people will see items only pertaining to high blood pressure.
Decisional Conflict Tool (SURE)
68 percentage of participants
78 percentage of participants
71 percentage of participants
68 percentage of participants
70 percentage of participants

SECONDARY outcome

Timeframe: Baseline survey

Population: Participants who answered all 5 decision regret questions. Only 526/533 participants provided enough information to calculate decision regret score.

5-item decision regret scale ranges from 0-100 with higher scores indicating greater decisional regret.

Outcome measures

Outcome measures
Measure
Colorectal Cancer Screening
n=139 Participants
People between the ages of 50-75 with no previous diagnosis of colon cancer, who have been screened for colon cancer (or discussed screening for colon cancer) in the past 2 years, or who had first colon cancer screening in past 2 years. These people will see items only pertaining to colon cancer screening.
Breast Cancer Screening
n=95 Participants
Females between the ages of 40-50 with no previous diagnosis of breast cancer who have had mammogram (or discussed having a mammogram) in the past 2 years, or had first mammogram in past 2 years. These people will see items only pertaining to breast cancer screening.
Prostate Cancer Screening
n=98 Participants
Men between the ages of 45-69 with no previous diagnosis of prostate cancer who have been screened for prostate cancer (or discussed screening for prostate cancer) in the past 2 years or had first prostate cancer screening in the past 2 years. These people will see items only pertaining to prostate cancer screening.
High Cholesterol
n=100 Participants
People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high cholesterol, who are either taking medication for high cholesterol for 2 years or less; or have discussed managing high cholesterol in the past 2 years. These people will see items only pertaining to high cholesterol.
High Blood Pressure
n=94 Participants
People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high blood pressure, who are either taking medication for high blood pressure for 2 years or less; or have discussed managing high blood pressure in the past 2 years. These people will see items only pertaining to high blood pressure.
Decision Regret Scale
17 score on a scale
Standard Deviation 18
16 score on a scale
Standard Deviation 16
25 score on a scale
Standard Deviation 22
22 score on a scale
Standard Deviation 18
27 score on a scale
Standard Deviation 18

SECONDARY outcome

Timeframe: Baseline survey

Population: participants who answered the single-item regret question.

Single item asking "If you knew then what you know now, do you think you would make the same decision about \[how to manage your high cholesterol/ how to manage your high blood pressure/breast cancer screening/colon cancer screening/ prostate cancer screening\]?" where the last part varies by group. Response options are: Definitely yes, Probably yes, Probably no, Definitely no

Outcome measures

Outcome measures
Measure
Colorectal Cancer Screening
n=140 Participants
People between the ages of 50-75 with no previous diagnosis of colon cancer, who have been screened for colon cancer (or discussed screening for colon cancer) in the past 2 years, or who had first colon cancer screening in past 2 years. These people will see items only pertaining to colon cancer screening.
Breast Cancer Screening
n=98 Participants
Females between the ages of 40-50 with no previous diagnosis of breast cancer who have had mammogram (or discussed having a mammogram) in the past 2 years, or had first mammogram in past 2 years. These people will see items only pertaining to breast cancer screening.
Prostate Cancer Screening
n=99 Participants
Men between the ages of 45-69 with no previous diagnosis of prostate cancer who have been screened for prostate cancer (or discussed screening for prostate cancer) in the past 2 years or had first prostate cancer screening in the past 2 years. These people will see items only pertaining to prostate cancer screening.
High Cholesterol
n=100 Participants
People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high cholesterol, who are either taking medication for high cholesterol for 2 years or less; or have discussed managing high cholesterol in the past 2 years. These people will see items only pertaining to high cholesterol.
High Blood Pressure
n=96 Participants
People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high blood pressure, who are either taking medication for high blood pressure for 2 years or less; or have discussed managing high blood pressure in the past 2 years. These people will see items only pertaining to high blood pressure.
Single-Item Measure of Decision Regret
Definitely yes
77 Participants
61 Participants
50 Participants
49 Participants
52 Participants
Single-Item Measure of Decision Regret
Probably yes
54 Participants
32 Participants
39 Participants
44 Participants
37 Participants
Single-Item Measure of Decision Regret
Probably no
8 Participants
4 Participants
7 Participants
5 Participants
7 Participants
Single-Item Measure of Decision Regret
Definitely no
1 Participants
1 Participants
3 Participants
2 Participants
0 Participants

SECONDARY outcome

Timeframe: Baseline survey

Population: participants who answered the treatment preference question.

Single item asking patient "What did you want to do" in regard to (depending on the group) high cholesterol/high blood pressure/colon cancer screening/breast cancer screening/prostate cancer screening

Outcome measures

Outcome measures
Measure
Colorectal Cancer Screening
n=140 Participants
People between the ages of 50-75 with no previous diagnosis of colon cancer, who have been screened for colon cancer (or discussed screening for colon cancer) in the past 2 years, or who had first colon cancer screening in past 2 years. These people will see items only pertaining to colon cancer screening.
Breast Cancer Screening
n=97 Participants
Females between the ages of 40-50 with no previous diagnosis of breast cancer who have had mammogram (or discussed having a mammogram) in the past 2 years, or had first mammogram in past 2 years. These people will see items only pertaining to breast cancer screening.
Prostate Cancer Screening
n=99 Participants
Men between the ages of 45-69 with no previous diagnosis of prostate cancer who have been screened for prostate cancer (or discussed screening for prostate cancer) in the past 2 years or had first prostate cancer screening in the past 2 years. These people will see items only pertaining to prostate cancer screening.
High Cholesterol
n=100 Participants
People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high cholesterol, who are either taking medication for high cholesterol for 2 years or less; or have discussed managing high cholesterol in the past 2 years. These people will see items only pertaining to high cholesterol.
High Blood Pressure
n=96 Participants
People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high blood pressure, who are either taking medication for high blood pressure for 2 years or less; or have discussed managing high blood pressure in the past 2 years. These people will see items only pertaining to high blood pressure.
Treatment Choice
take medicine/(start) screen for cancer
123 Participants
72 Participants
71 Participants
37 Participants
64 Participants
Treatment Choice
not take medicine/(wait) not screen for cancer
16 Participants
19 Participants
25 Participants
61 Participants
32 Participants
Treatment Choice
other
1 Participants
6 Participants
3 Participants
2 Participants
0 Participants

SECONDARY outcome

Timeframe: Baseline survey

Population: participants who answered the controlled preference scale question.

Single item asking the participant who made the ultimate decision. The categorical response options are 1) the patient made the decision, 2)the provider made the decision, or 3) both patient and provider made the decision together.

Outcome measures

Outcome measures
Measure
Colorectal Cancer Screening
n=140 Participants
People between the ages of 50-75 with no previous diagnosis of colon cancer, who have been screened for colon cancer (or discussed screening for colon cancer) in the past 2 years, or who had first colon cancer screening in past 2 years. These people will see items only pertaining to colon cancer screening.
Breast Cancer Screening
n=98 Participants
Females between the ages of 40-50 with no previous diagnosis of breast cancer who have had mammogram (or discussed having a mammogram) in the past 2 years, or had first mammogram in past 2 years. These people will see items only pertaining to breast cancer screening.
Prostate Cancer Screening
n=99 Participants
Men between the ages of 45-69 with no previous diagnosis of prostate cancer who have been screened for prostate cancer (or discussed screening for prostate cancer) in the past 2 years or had first prostate cancer screening in the past 2 years. These people will see items only pertaining to prostate cancer screening.
High Cholesterol
n=100 Participants
People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high cholesterol, who are either taking medication for high cholesterol for 2 years or less; or have discussed managing high cholesterol in the past 2 years. These people will see items only pertaining to high cholesterol.
High Blood Pressure
n=96 Participants
People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high blood pressure, who are either taking medication for high blood pressure for 2 years or less; or have discussed managing high blood pressure in the past 2 years. These people will see items only pertaining to high blood pressure.
Adapted Controlled Preference Scale
Mainly my decision
59 Participants
49 Participants
68 Participants
43 Participants
46 Participants
Adapted Controlled Preference Scale
Mainly the healthcare provider's decision
25 Participants
13 Participants
10 Participants
18 Participants
24 Participants
Adapted Controlled Preference Scale
We made the decision together
56 Participants
36 Participants
21 Participants
39 Participants
26 Participants

SECONDARY outcome

Timeframe: 1 week after baseline survey

Population: Participants who completed the baseline survey were re-contacted approximately 1 week post-survey for a retest. Participants who completed the retest survey and provided enough information to calculate the shared decision making process score were part of this analysis.

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 occurred.

Outcome measures

Outcome measures
Measure
Colorectal Cancer Screening
n=65 Participants
People between the ages of 50-75 with no previous diagnosis of colon cancer, who have been screened for colon cancer (or discussed screening for colon cancer) in the past 2 years, or who had first colon cancer screening in past 2 years. These people will see items only pertaining to colon cancer screening.
Breast Cancer Screening
n=42 Participants
Females between the ages of 40-50 with no previous diagnosis of breast cancer who have had mammogram (or discussed having a mammogram) in the past 2 years, or had first mammogram in past 2 years. These people will see items only pertaining to breast cancer screening.
Prostate Cancer Screening
n=38 Participants
Men between the ages of 45-69 with no previous diagnosis of prostate cancer who have been screened for prostate cancer (or discussed screening for prostate cancer) in the past 2 years or had first prostate cancer screening in the past 2 years. These people will see items only pertaining to prostate cancer screening.
High Cholesterol
n=45 Participants
People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high cholesterol, who are either taking medication for high cholesterol for 2 years or less; or have discussed managing high cholesterol in the past 2 years. These people will see items only pertaining to high cholesterol.
High Blood Pressure
n=40 Participants
People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high blood pressure, who are either taking medication for high blood pressure for 2 years or less; or have discussed managing high blood pressure in the past 2 years. These people will see items only pertaining to high blood pressure.
Shared Decision Making Process Measure Retest
1.68 score on a scale
Standard Deviation 1.13
1.57 score on a scale
Standard Deviation 1.18
1.67 score on a scale
Standard Deviation 1.02
2.27 score on a scale
Standard Deviation 1.02
2.32 score on a scale
Standard Deviation 1.42

SECONDARY outcome

Timeframe: Baseline survey

Population: participants who answered at least 50% of the knowledge items in their respective clinical groups. Participants in the high cholesterol group were not given a knowledge score. Only 131/234 provided enough information to calculate a shared decision making process score (primary outcome of interest)

Multiple choice knowledge items for each topic will be combined to a total knowledge score (0-100) with higher scores indicating higher knowledge

Outcome measures

Outcome measures
Measure
Colorectal Cancer Screening
n=137 Participants
People between the ages of 50-75 with no previous diagnosis of colon cancer, who have been screened for colon cancer (or discussed screening for colon cancer) in the past 2 years, or who had first colon cancer screening in past 2 years. These people will see items only pertaining to colon cancer screening.
Breast Cancer Screening
n=98 Participants
Females between the ages of 40-50 with no previous diagnosis of breast cancer who have had mammogram (or discussed having a mammogram) in the past 2 years, or had first mammogram in past 2 years. These people will see items only pertaining to breast cancer screening.
Prostate Cancer Screening
n=99 Participants
Men between the ages of 45-69 with no previous diagnosis of prostate cancer who have been screened for prostate cancer (or discussed screening for prostate cancer) in the past 2 years or had first prostate cancer screening in the past 2 years. These people will see items only pertaining to prostate cancer screening.
High Cholesterol
People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high cholesterol, who are either taking medication for high cholesterol for 2 years or less; or have discussed managing high cholesterol in the past 2 years. These people will see items only pertaining to high cholesterol.
High Blood Pressure
n=96 Participants
People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high blood pressure, who are either taking medication for high blood pressure for 2 years or less; or have discussed managing high blood pressure in the past 2 years. These people will see items only pertaining to high blood pressure.
Knowledge
56 score on a scale
Standard Deviation 22
40 score on a scale
Standard Deviation 18
43 score on a scale
Standard Deviation 26
61 score on a scale
Standard Deviation 29

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline survey

Population: participants in the high cholesterol and high blood pressure groups who answered all 3 medication adherence questions. participants in the three cancer screening groups were not assigned medication adherence questions and thus were not part of this analysis. Only 56/100 (high cholesterol) and 68/96 (high blood pressure) participants provided enough information to calculate adherence score.

3 item measure of adherence to medication asked for the high cholesterol and high blood pressure sample participants who indicate that they are taking medicine. (patients in the cancer screening arm did not get this question). composite score ranged from 0-100, with higher scores indicating greater adherence to medication within the last 30 days.

Outcome measures

Outcome measures
Measure
Colorectal Cancer Screening
People between the ages of 50-75 with no previous diagnosis of colon cancer, who have been screened for colon cancer (or discussed screening for colon cancer) in the past 2 years, or who had first colon cancer screening in past 2 years. These people will see items only pertaining to colon cancer screening.
Breast Cancer Screening
Females between the ages of 40-50 with no previous diagnosis of breast cancer who have had mammogram (or discussed having a mammogram) in the past 2 years, or had first mammogram in past 2 years. These people will see items only pertaining to breast cancer screening.
Prostate Cancer Screening
Men between the ages of 45-69 with no previous diagnosis of prostate cancer who have been screened for prostate cancer (or discussed screening for prostate cancer) in the past 2 years or had first prostate cancer screening in the past 2 years. These people will see items only pertaining to prostate cancer screening.
High Cholesterol
n=56 Participants
People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high cholesterol, who are either taking medication for high cholesterol for 2 years or less; or have discussed managing high cholesterol in the past 2 years. These people will see items only pertaining to high cholesterol.
High Blood Pressure
n=68 Participants
People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high blood pressure, who are either taking medication for high blood pressure for 2 years or less; or have discussed managing high blood pressure in the past 2 years. These people will see items only pertaining to high blood pressure.
Adherence
85 score on a scale
Standard Deviation 19
87 score on a scale
Standard Deviation 14

Adverse Events

High Cholesterol

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

High Blood Pressure

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Colorectal Cancer Screening

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Breast 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

Dr. Karen R. Sepucha

Massachusetts General Hospital

Phone: 617-724-3350

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place