Trial Outcomes & Findings for Mychoice: Testing an Interactive mHealth Tool (NCT NCT03427177)
NCT ID: NCT03427177
Last Updated: 2021-01-27
Results Overview
10-item scale measuring patient confidence in communicating with their physician. Participants respond to each question on a scale of 1 to 5, with 5 representing "very confident,'' and 1 representing "not at all confident." The range of possible scores for the full PEPPI scale is 10 to 50 (50 representing highest patient-perceived self-efficacy).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
257 participants
Primary outcome timeframe
Baseline and post-test (both occur on same day, day 1), one month follow-up
Results posted on
2021-01-27
Participant Flow
Participant milestones
| Measure |
Treatment
Participants randomized to the treatment arm of the study will be given the mychoice tool.
mychoice: The mychoice communication tool begins to prepare patients to participate in a personal and tailored discussion with their provider about clinical trials as a potential treatment option. It is also customized to address the concerns of those least likely to participate, instead of providing a more general look at clinical trials- a common trait of other available tools.
|
Control
Participants randomized to the control arm of the study will be given existing literature from the NCI that describes clinical trials (standard information for newly diagnosed cancer patients).
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
132
|
|
Overall Study
COMPLETED
|
92
|
105
|
|
Overall Study
NOT COMPLETED
|
33
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mychoice: Testing an Interactive mHealth Tool
Baseline characteristics by cohort
| Measure |
Treatment
n=122 Participants
Participants randomized to the treatment arm of the study will be given the mychoice tool.
mychoice: The mychoice communication tool begins to prepare patients to participate in a personal and tailored discussion with their provider about clinical trials as a potential treatment option. It is also customized to address the concerns of those least likely to participate, instead of providing a more general look at clinical trials- a common trait of other available tools.
|
Control
n=128 Participants
Participants randomized to the control arm of the study will be given existing literature from the NCI that describes clinical trials (standard information for newly diagnosed cancer patients).
|
Total
n=250 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
68 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
54 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
101 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
203 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
45 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
68 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
122 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
250 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and post-test (both occur on same day, day 1), one month follow-upPopulation: There was participant drop off between baseline, post-test, and follow-up.
10-item scale measuring patient confidence in communicating with their physician. Participants respond to each question on a scale of 1 to 5, with 5 representing "very confident,'' and 1 representing "not at all confident." The range of possible scores for the full PEPPI scale is 10 to 50 (50 representing highest patient-perceived self-efficacy).
Outcome measures
| Measure |
Treatment
n=121 Participants
Participants randomized to the treatment arm of the study will be given the mychoice tool.
mychoice: The mychoice communication tool begins to prepare patients to participate in a personal and tailored discussion with their provider about clinical trials as a potential treatment option. It is also customized to address the concerns of those least likely to participate, instead of providing a more general look at clinical trials- a common trait of other available tools.
|
Control
n=126 Participants
Participants randomized to the control arm of the study will be given existing literature from the NCI that describes clinical trials (standard information for newly diagnosed cancer patients).
|
|---|---|---|
|
Perceived Efficacy in Patient-Physician Interactions (PEPPI) Self-Efficacy Scale- Outcome Measure at Baseline, Post-test and One Month Follow-up
Baseline
|
44.6 score on a scale
Standard Deviation 5.8
|
44.0 score on a scale
Standard Deviation 8.3
|
|
Perceived Efficacy in Patient-Physician Interactions (PEPPI) Self-Efficacy Scale- Outcome Measure at Baseline, Post-test and One Month Follow-up
Post-test
|
44.3 score on a scale
Standard Deviation 6.5
|
44.4 score on a scale
Standard Deviation 7.1
|
|
Perceived Efficacy in Patient-Physician Interactions (PEPPI) Self-Efficacy Scale- Outcome Measure at Baseline, Post-test and One Month Follow-up
Follow-up
|
44.8 score on a scale
Standard Deviation 6.0
|
44.2 score on a scale
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: 1 month follow-upPopulation: Participants were only asked these questions if their doctor talked to them about participating in a clinical trial prior to completing follow-up.
Measure of patient perceptions of physician effort to discuss concerns, 3 items. There is a possible range of 0-9 for each item. Higher scores represent more shared decision making.
Outcome measures
| Measure |
Treatment
n=33 Participants
Participants randomized to the treatment arm of the study will be given the mychoice tool.
mychoice: The mychoice communication tool begins to prepare patients to participate in a personal and tailored discussion with their provider about clinical trials as a potential treatment option. It is also customized to address the concerns of those least likely to participate, instead of providing a more general look at clinical trials- a common trait of other available tools.
|
Control
n=35 Participants
Participants randomized to the control arm of the study will be given existing literature from the NCI that describes clinical trials (standard information for newly diagnosed cancer patients).
|
|---|---|---|
|
CollaboRATE Perceived Shared Decision Making Scale
How much effort was made to help you understand clinical trials?
|
3.82 score on a scale
Standard Deviation 1.185
|
3.74 score on a scale
Standard Deviation 1.039
|
|
CollaboRATE Perceived Shared Decision Making Scale
How much effort was made to listen to the things that matter most to you about clinical trials?
|
3.76 score on a scale
Standard Deviation 1.300
|
3.71 score on a scale
Standard Deviation 1.017
|
|
CollaboRATE Perceived Shared Decision Making Scale
How much effort was made to include what matters most to you in choosing what to do next?
|
3.97 score on a scale
Standard Deviation 1.185
|
3.69 score on a scale
Standard Deviation 1.022
|
SECONDARY outcome
Timeframe: 1 month follow-upPopulation: Only participants who were offered a clinical trial were asked these questions.
Measure of patient perception of shared decision making with provider (12 items). The instrument's statements are rated on a six-point scale from ''completely disagree'' (0) to ''completely agree'' (5). Higher means indicate higher levels of perceived shared decision making.
Outcome measures
| Measure |
Treatment
n=32 Participants
Participants randomized to the treatment arm of the study will be given the mychoice tool.
mychoice: The mychoice communication tool begins to prepare patients to participate in a personal and tailored discussion with their provider about clinical trials as a potential treatment option. It is also customized to address the concerns of those least likely to participate, instead of providing a more general look at clinical trials- a common trait of other available tools.
|
Control
n=36 Participants
Participants randomized to the control arm of the study will be given existing literature from the NCI that describes clinical trials (standard information for newly diagnosed cancer patients).
|
|---|---|---|
|
Shared Decision Making (SDM Q-9) Scale
My doctor made it clear that a decision needs to be made.
|
4.19 score on a scale
Standard Deviation 1.642
|
4.09 score on a scale
Standard Deviation 1.652
|
|
Shared Decision Making (SDM Q-9) Scale
My doctor wanted to know exactly how I want to be involved in making a decision.
|
4.29 score on a scale
Standard Deviation 1.657
|
4.23 score on a scale
Standard Deviation 1.592
|
|
Shared Decision Making (SDM Q-9) Scale
My doctor toldme that there are different options for treating my medical condition.
|
4.78 score on a scale
Standard Deviation 1.237
|
4.67 score on a scale
Standard Deviation 1.414
|
|
Shared Decision Making (SDM Q-9) Scale
My doctor precisely explained the advantages and disadvantages of clinical trials.
|
4.13 score on a scale
Standard Deviation 1.755
|
4.20 score on a scale
Standard Deviation 1.623
|
|
Shared Decision Making (SDM Q-9) Scale
My doctor helped me understand all the information for clinical trials.
|
3.90 score on a scale
Standard Deviation 1.578
|
4.29 score on a scale
Standard Deviation 1.526
|
|
Shared Decision Making (SDM Q-9) Scale
My doctor asked me which treatment option I prefer.
|
4.16 score on a scale
Standard Deviation 1.798
|
4.49 score on a scale
Standard Deviation 1.541
|
|
Shared Decision Making (SDM Q-9) Scale
My doctor and I thoroughly weighed the different treatment options.
|
4.19 score on a scale
Standard Deviation 1.857
|
4.69 score on a scale
Standard Deviation 1.367
|
|
Shared Decision Making (SDM Q-9) Scale
My doctor and I selected a treatment option together.
|
4.66 score on a scale
Standard Deviation 1.619
|
4.54 score on a scale
Standard Deviation 1.540
|
|
Shared Decision Making (SDM Q-9) Scale
My doctor and I reached an agreement on how to proceed.
|
4.81 score on a scale
Standard Deviation 1.52
|
4.60 score on a scale
Standard Deviation .479
|
SECONDARY outcome
Timeframe: Baseline and post-test (both occur on same day, day 1), one month follow-up13 item measure to determine patient clarity on the risks and benefits of clinical trials, support from friends and family, and patient decision regarding cancer treatment. Items are given a score value of: 0= 'strongly agree'; 2= 'neither agree nor disagree'; 3= 'disagree'; 4= 'strongly disagree' TOTAL SCORE 16 items \[items 1-16 are inclusive\] are: a) summed; b) divided by 16; and c) multiplied by 25. Scores range from 0 \[no decisional conflict\] to 100 \[extremely high decisional conflict\]
Outcome measures
| Measure |
Treatment
n=122 Participants
Participants randomized to the treatment arm of the study will be given the mychoice tool.
mychoice: The mychoice communication tool begins to prepare patients to participate in a personal and tailored discussion with their provider about clinical trials as a potential treatment option. It is also customized to address the concerns of those least likely to participate, instead of providing a more general look at clinical trials- a common trait of other available tools.
|
Control
n=128 Participants
Participants randomized to the control arm of the study will be given existing literature from the NCI that describes clinical trials (standard information for newly diagnosed cancer patients).
|
|---|---|---|
|
Ottawa Decisional Conflict
Baseline
|
32.0 score on a scale
Standard Deviation 19.8
|
31.6 score on a scale
Standard Deviation 20.5
|
|
Ottawa Decisional Conflict
Post-test
|
24.5 score on a scale
Standard Deviation 147
|
26.2 score on a scale
Standard Deviation 18.8
|
|
Ottawa Decisional Conflict
Follow-up
|
27.1 score on a scale
Standard Deviation 18.3
|
28.7 score on a scale
Standard Deviation 17.5
|
SECONDARY outcome
Timeframe: Post test (day 1)Measures preparedness of patient to make a decision (10 items) on a 1 "not at all" to 5 "a great deal" scale. Higher means indicated higher perceived level of preparation for decision making.
Outcome measures
| Measure |
Treatment
n=104 Participants
Participants randomized to the treatment arm of the study will be given the mychoice tool.
mychoice: The mychoice communication tool begins to prepare patients to participate in a personal and tailored discussion with their provider about clinical trials as a potential treatment option. It is also customized to address the concerns of those least likely to participate, instead of providing a more general look at clinical trials- a common trait of other available tools.
|
Control
n=120 Participants
Participants randomized to the control arm of the study will be given existing literature from the NCI that describes clinical trials (standard information for newly diagnosed cancer patients).
|
|---|---|---|
|
Preparation for Decision Making (PrepDM) Scale
How much did the edu... Help you recognize that a decision needs to be made about clinical trials?
|
3.7 score on a scale
Standard Deviation 1.1
|
3.7 score on a scale
Standard Deviation 1.2
|
|
Preparation for Decision Making (PrepDM) Scale
Prepare you to make a better decision about clinical trials?
|
3.9 score on a scale
Standard Deviation .9
|
3.9 score on a scale
Standard Deviation 1.1
|
|
Preparation for Decision Making (PrepDM) Scale
Help you think about the pros and cons of treatment options?
|
3.9 score on a scale
Standard Deviation 1.0
|
3.9 score on a scale
Standard Deviation 1.1
|
|
Preparation for Decision Making (PrepDM) Scale
Help you think about which pros and cons are most important?
|
3.9 score on a scale
Standard Deviation 1.0
|
3.8 score on a scale
Standard Deviation 1.2
|
|
Preparation for Decision Making (PrepDM) Scale
Help you know that the decision depends on what matters most to you?
|
4.1 score on a scale
Standard Deviation .9
|
4.0 score on a scale
Standard Deviation 1.0
|
|
Preparation for Decision Making (PrepDM) Scale
Help you organize your own thoughts about the decision?
|
4.0 score on a scale
Standard Deviation 1.0
|
3.9 score on a scale
Standard Deviation 1.0
|
|
Preparation for Decision Making (PrepDM) Scale
Help you think about how involved you want to be in this decision?
|
4.1 score on a scale
Standard Deviation 1.0
|
4.1 score on a scale
Standard Deviation 1.0
|
|
Preparation for Decision Making (PrepDM) Scale
Help you identify questions you want to ask your doctor?
|
4.1 score on a scale
Standard Deviation .9
|
4.1 score on a scale
Standard Deviation 1.0
|
|
Preparation for Decision Making (PrepDM) Scale
Prepare you to talk to your doctor about what matters most to you?
|
4.1 score on a scale
Standard Deviation .9
|
4.1 score on a scale
Standard Deviation 1.0
|
|
Preparation for Decision Making (PrepDM) Scale
Prepare you for a follow-up visit with your doctor?
|
3.8 score on a scale
Standard Deviation 1.0
|
3.9 score on a scale
Standard Deviation 1.2
|
Adverse Events
Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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