Trial Outcomes & Findings for Health Literacy Intervention for Informed Consent of Cancer Patients Considering Clinical Trial Participation (NCT NCT01964222)
NCT ID: NCT01964222
Last Updated: 2015-12-07
Results Overview
A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include eleven knowledge items such as "Only very sick patients are asked to take part in a cancer research study" and "Cancer research studies almost never involve the use of a placebo or sugar pill alone". Participants will indicate each item as "True", "False", or "I don't know". An overall knowledge composite score will be created with the average percentage of items participants in each condition correctly answer. Participation in study concludes upon completion of questionnaire.
COMPLETED
NA
201 participants
1 day (Immediately following either showing the participant the experimental or control information (same day)
2015-12-07
Participant Flow
Participant milestones
| Measure |
Decision Aid (DA)
The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.
Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care.
|
Control
Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
100
|
|
Overall Study
COMPLETED
|
86
|
89
|
|
Overall Study
NOT COMPLETED
|
15
|
11
|
Reasons for withdrawal
| Measure |
Decision Aid (DA)
The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.
Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care.
|
Control
Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
5
|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
|
Overall Study
Screening Failure
|
2
|
0
|
Baseline Characteristics
Health Literacy Intervention for Informed Consent of Cancer Patients Considering Clinical Trial Participation
Baseline characteristics by cohort
| Measure |
Decision Aid (DA)
n=86 Participants
The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.
Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care.
|
Control
n=89 Participants
Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
|
Total
n=175 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.81 years
STANDARD_DEVIATION 12.26 • n=5 Participants
|
53.88 years
STANDARD_DEVIATION 12.05 • n=7 Participants
|
54.83 years
STANDARD_DEVIATION 12.16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
85 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 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
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Rapid Estimate of Adult Literacy in Medicine-SF (REALM-SF)
Inadequate
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Rapid Estimate of Adult Literacy in Medicine-SF (REALM-SF)
Marginal
|
20 participants
n=5 Participants
|
13 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Rapid Estimate of Adult Literacy in Medicine-SF (REALM-SF)
Adequate
|
61 participants
n=5 Participants
|
66 participants
n=7 Participants
|
127 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 day (Immediately following either showing the participant the experimental or control information (same day)Population: Analysis is represented as mean (standard deviation) of percentage of knowledge questions answered correctly.
A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include eleven knowledge items such as "Only very sick patients are asked to take part in a cancer research study" and "Cancer research studies almost never involve the use of a placebo or sugar pill alone". Participants will indicate each item as "True", "False", or "I don't know". An overall knowledge composite score will be created with the average percentage of items participants in each condition correctly answer. Participation in study concludes upon completion of questionnaire.
Outcome measures
| Measure |
Decision Aid (DA)
n=86 Participants
The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.
Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care.
|
Control
n=89 Participants
Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
|
|---|---|---|
|
Knowledge About Cancer Clinical Trials
|
73.4 percentage questions answered correctly
Standard Deviation 21.6
|
61.6 percentage questions answered correctly
Standard Deviation 18.8
|
PRIMARY outcome
Timeframe: 1 day (Immediately following either showing the participant the experimental or control information (same day)Population: Analysis is represented as mean (standard deviation) of calculated values clarity.
A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include the Values Clarity Subscale to evaluate decisional conflict. The subscale includes two items from the ten-item Low Literacy Decisional Conflict Scale, each with three response categories. The combined score on the two items will be divided by 2 and multiplied by 25 to produce an overall "values clarity" score from 0 to 100. Higher values represent less clarity. Participation in study concludes upon completion of questionnaire.
Outcome measures
| Measure |
Decision Aid (DA)
n=86 Participants
The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.
Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care.
|
Control
n=89 Participants
Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
|
|---|---|---|
|
Clarity of Values
|
16.6 units on a scale of 0 to 100
Standard Deviation 27
|
33 units on a scale of 0 to 100
Standard Deviation 36.5
|
PRIMARY outcome
Timeframe: 1 day Immediately following either showing the participant the experimental or control information (same day)Population: Analysis is represented as mean (standard deviation) of calculated uncertainty.
A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include the Uncertainty Subscale to evaluate decisional conflict. The subscale includes two items from the ten-item Low Literacy Decisional Conflict Scale, each with three response categories. The combined score on the two items will be divided by 2 and multiplied by 25 to produce an overall "uncertainty" score from 0 to 100. Higher values represent more uncertainty. Participation in study concludes upon completion of questionnaire.
Outcome measures
| Measure |
Decision Aid (DA)
n=86 Participants
The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.
Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care.
|
Control
n=89 Participants
Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
|
|---|---|---|
|
Uncertainty in Choice
|
23 units on a scale of 0 to 100
Standard Deviation 30.3
|
33.2 units on a scale of 0 to 100
Standard Deviation 33.2
|
SECONDARY outcome
Timeframe: 1 day (Immediately following either showing the participant the experimental or control information (same day)Population: Analysis is represented as mean (standard deviation) of participant-reported self-efficacy for finding information about cancer clinical trials.
A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include an item in which participants rank their self-efficacy for finding information about cancer clinical trials on a 5-point scale with higher numbers indicating greater self-efficacy. Participation in study concludes upon completion of questionnaire.
Outcome measures
| Measure |
Decision Aid (DA)
n=86 Participants
The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.
Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care.
|
Control
n=89 Participants
Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
|
|---|---|---|
|
Self-efficacy for Communicating About Cancer Clinical Trials
|
4.1 units on a scale of 1 to 5
Standard Deviation 1.0
|
3.5 units on a scale of 1 to 5
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 1 day (Immediately following either showing the participant the experimental or control information (same day)Population: Analysis is represented as mean (standard deviation) of participant-reported intent.
A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include two items in which participants rank their intent to participate in a cancer clinical trial and their intent to encourage others to participate in a cancer clinical trial on a 5-point scale with higher numbers indicating greater intent. Participation in study concludes upon completion of questionnaire.
Outcome measures
| Measure |
Decision Aid (DA)
n=86 Participants
The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.
Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care.
|
Control
n=89 Participants
Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
|
|---|---|---|
|
Attitudes About Cancer Clinical Trials
Intent to Participate
|
3.8 units on a scale of 1 to 5
Standard Deviation 1.1
|
3.8 units on a scale of 1 to 5
Standard Deviation 1.1
|
|
Attitudes About Cancer Clinical Trials
Intent to Encourage Others to Particpate
|
3.7 units on a scale of 1 to 5
Standard Deviation 1.1
|
3.7 units on a scale of 1 to 5
Standard Deviation 1.0
|
Adverse Events
Decision Aid (DA)
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mary C. Politi, PhD
Washington University's School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place