Trial Outcomes & Findings for Easy-to-Read Informed Consent (ETRIC) for Hematopoietic Cell Transplantation Clinical Trials (BMT CTN 1205) (NCT NCT02081248)
NCT ID: NCT02081248
Last Updated: 2022-12-08
Results Overview
The primary objective of the trial is to compare objective comprehension scores on the Quality of Informed Consent (part A) instrument between subjects randomized to the ETRIC versus the standard consent arms. The QuIC-A is scored on a normalized scale from 0 to 100, with a higher score indicating a greater level of comprehension.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
198 participants
Primary outcome timeframe
Within 7 days of consent discussion
Results posted on
2022-12-08
Participant Flow
Participant milestones
| Measure |
Standard Consent
This arm will receive the Consent Form Specific Format 1 'standard consent'. The standard consents are already approved and used for the BMT CTN 0901, 1101, 1203, and 1301 trials.
Consent Form Specific Format 1: The Consent Form Specific Format 1 is the 'Standard Consent'. The standard consent does not have the format of two-columns with changes in layout readability, organization of content, typography and use of plain language. Standard consents are already used by sites for the BMT CTN 0901, 1101, 1203, and 1301 clinical trials.
|
Easy-to-Read Informed Consent
This arm will receive the Consent Form Specific Format 2 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent (ETRIC) is the newly approved consent.
Consent Form Specific Format 2: The Consent Form Specific Format 2 is the 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent is two-columns with changes in layout readability, organization of content, typography and use of plain language.
|
|---|---|---|
|
Overall Study
STARTED
|
98
|
100
|
|
Overall Study
COMPLETED
|
76
|
87
|
|
Overall Study
NOT COMPLETED
|
22
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Easy-to-Read Informed Consent (ETRIC) for Hematopoietic Cell Transplantation Clinical Trials (BMT CTN 1205)
Baseline characteristics by cohort
| Measure |
Standard Consent
n=98 Participants
This arm will receive the Consent Form Specific Format 1 'standard consent'. The standard consents are already approved and used for the BMT CTN 0901, 1101, 1203, and 1301 trials.
Consent Form Specific Format 1: The Consent Form Specific Format 1 is the 'Standard Consent'. The standard consent does not have the format of two-columns with changes in layout readability, organization of content, typography and use of plain language. Standard consents are already used by sites for the BMT CTN 0901, 1101, 1203, and 1301 clinical trials.
|
Easy-to-Read Informed Consent
n=100 Participants
This arm will receive the Consent Form Specific Format 2 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent (ETRIC) is the newly approved consent.
Consent Form Specific Format 2: The Consent Form Specific Format 2 is the 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent is two-columns with changes in layout readability, organization of content, typography and use of plain language.
|
Total
n=198 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
61 years
n=7 Participants
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
87 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
85 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Annual Household Income
Less than $40,000
|
11 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Annual Household Income
$40,000-79,999
|
25 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Annual Household Income
$80,000 or More
|
22 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Annual Household Income
Unknown or Not Reported
|
40 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Education Level
High School or Less
|
20 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Education Level
Post-high School, but Less than Graduate Degree
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Education Level
Graduate Degree or More
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Education Level
Other
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Education Level
Unknown or Not Reported
|
29 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Parent Clinical Trial
BMT CTN 0901
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Parent Clinical Trial
BMT CTN 1101
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Parent Clinical Trial
BMT CTN 1203
|
50 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Parent Clinical Trial
BMT CTN 1301
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 7 days of consent discussionPopulation: Participants completing the QuIC-A assessment
The primary objective of the trial is to compare objective comprehension scores on the Quality of Informed Consent (part A) instrument between subjects randomized to the ETRIC versus the standard consent arms. The QuIC-A is scored on a normalized scale from 0 to 100, with a higher score indicating a greater level of comprehension.
Outcome measures
| Measure |
Standard Consent
n=71 Participants
This arm will receive the Consent Form Specific Format 1 'standard consent'. The standard consents are already approved and used for the BMT CTN 0901, 1101, 1203, and 1301 trials.
Consent Form Specific Format 1: The Consent Form Specific Format 1 is the 'Standard Consent'. The standard consent does not have the format of two-columns with changes in layout readability, organization of content, typography and use of plain language. Standard consents are already used by sites for the BMT CTN 0901, 1101, 1203, and 1301 clinical trials.
|
Easy-to-Read Informed Consent
n=81 Participants
This arm will receive the Consent Form Specific Format 2 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent (ETRIC) is the newly approved consent.
Consent Form Specific Format 2: The Consent Form Specific Format 2 is the 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent is two-columns with changes in layout readability, organization of content, typography and use of plain language.
|
|---|---|---|
|
Quality of Informed Consent Part A (QuIC-A) Score
|
81.8 units on a scale
Standard Deviation 9.5
|
80.5 units on a scale
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: Within 7 days of consent discussionPopulation: Participants completing the QuIC-B assessment
The Quality of Informed Consent Part B measures participants' perception of their understanding of cancer clinical trials to address 13 independent domains of informed consent. The QuIC-B is scored on a normalized scale from 0 to 100, with a higher score indicating a greater level of perceived understanding.
Outcome measures
| Measure |
Standard Consent
n=71 Participants
This arm will receive the Consent Form Specific Format 1 'standard consent'. The standard consents are already approved and used for the BMT CTN 0901, 1101, 1203, and 1301 trials.
Consent Form Specific Format 1: The Consent Form Specific Format 1 is the 'Standard Consent'. The standard consent does not have the format of two-columns with changes in layout readability, organization of content, typography and use of plain language. Standard consents are already used by sites for the BMT CTN 0901, 1101, 1203, and 1301 clinical trials.
|
Easy-to-Read Informed Consent
n=81 Participants
This arm will receive the Consent Form Specific Format 2 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent (ETRIC) is the newly approved consent.
Consent Form Specific Format 2: The Consent Form Specific Format 2 is the 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent is two-columns with changes in layout readability, organization of content, typography and use of plain language.
|
|---|---|---|
|
Quality of Informed Consent Part B (QuIC-B) Score
|
98.2 units on a scale
Interval 91.9 to 100.0
|
96.4 units on a scale
Interval 89.3 to 100.0
|
SECONDARY outcome
Timeframe: WIthin 7 days of consent discussionPopulation: Participants completing the modified DICCT assessment
The Modified Deaconess Informed Consent Comprehension Test (DICCT) uses semi-structured interviews to assess subject's understanding of the study for which they participated in an informed consent discussion. This modification of the DICCT has 11 items, each scored from 0 to 2 (0 = incorrect, 1 = partially correct, 2 = correct). The item scores are summed to produce a total score ranging from 0 to 22. A higher score indicates a higher level of comprehension.
Outcome measures
| Measure |
Standard Consent
n=73 Participants
This arm will receive the Consent Form Specific Format 1 'standard consent'. The standard consents are already approved and used for the BMT CTN 0901, 1101, 1203, and 1301 trials.
Consent Form Specific Format 1: The Consent Form Specific Format 1 is the 'Standard Consent'. The standard consent does not have the format of two-columns with changes in layout readability, organization of content, typography and use of plain language. Standard consents are already used by sites for the BMT CTN 0901, 1101, 1203, and 1301 clinical trials.
|
Easy-to-Read Informed Consent
n=84 Participants
This arm will receive the Consent Form Specific Format 2 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent (ETRIC) is the newly approved consent.
Consent Form Specific Format 2: The Consent Form Specific Format 2 is the 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent is two-columns with changes in layout readability, organization of content, typography and use of plain language.
|
|---|---|---|
|
Modified Deaconess Informed Consent Comprehension Test (DICCT)
|
15 units on a scale
Interval 13.0 to 17.0
|
15 units on a scale
Interval 14.0 to 17.0
|
SECONDARY outcome
Timeframe: Within 7 days of consent discussionThe Rapid Estimate of Adult Literacy in Medicine-Revised (REALM-R) is an 8-item word recognition test to provide clinicians with a valid quick assessment of patient health literacy. The score is computed as the number of words out of 8 that the patient pronounces correctly.
Outcome measures
| Measure |
Standard Consent
n=98 Participants
This arm will receive the Consent Form Specific Format 1 'standard consent'. The standard consents are already approved and used for the BMT CTN 0901, 1101, 1203, and 1301 trials.
Consent Form Specific Format 1: The Consent Form Specific Format 1 is the 'Standard Consent'. The standard consent does not have the format of two-columns with changes in layout readability, organization of content, typography and use of plain language. Standard consents are already used by sites for the BMT CTN 0901, 1101, 1203, and 1301 clinical trials.
|
Easy-to-Read Informed Consent
n=100 Participants
This arm will receive the Consent Form Specific Format 2 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent (ETRIC) is the newly approved consent.
Consent Form Specific Format 2: The Consent Form Specific Format 2 is the 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent is two-columns with changes in layout readability, organization of content, typography and use of plain language.
|
|---|---|---|
|
REALM-R Score
8
|
62 Participants
|
69 Participants
|
|
REALM-R Score
Less Than 8
|
15 Participants
|
17 Participants
|
|
REALM-R Score
Not Completed
|
21 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Within 7 days of consent discussionThe Newest Vital Sign is a screening tool that identifies patients at risk for low health literacy. It consists of a nutritional label accompanied by five questions about information on the label. The score is equal to the number of questions answered correctly.
Outcome measures
| Measure |
Standard Consent
n=98 Participants
This arm will receive the Consent Form Specific Format 1 'standard consent'. The standard consents are already approved and used for the BMT CTN 0901, 1101, 1203, and 1301 trials.
Consent Form Specific Format 1: The Consent Form Specific Format 1 is the 'Standard Consent'. The standard consent does not have the format of two-columns with changes in layout readability, organization of content, typography and use of plain language. Standard consents are already used by sites for the BMT CTN 0901, 1101, 1203, and 1301 clinical trials.
|
Easy-to-Read Informed Consent
n=100 Participants
This arm will receive the Consent Form Specific Format 2 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent (ETRIC) is the newly approved consent.
Consent Form Specific Format 2: The Consent Form Specific Format 2 is the 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent is two-columns with changes in layout readability, organization of content, typography and use of plain language.
|
|---|---|---|
|
Newest Vital Sign (NVS) Score
Less Than 4
|
11 Participants
|
16 Participants
|
|
Newest Vital Sign (NVS) Score
4
|
53 Participants
|
52 Participants
|
|
Newest Vital Sign (NVS) Score
5
|
13 Participants
|
18 Participants
|
|
Newest Vital Sign (NVS) Score
Not Completed
|
21 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Within 7 days of consent discussionPopulation: Participants completing the STAI assessment
The State Trait Anxiety Inventory (STAI) measures anxiety and distinguishes it from depressive syndromes. It has two subscales: the State Anxiety Scale evaluates the current state of anxiety, asking how respondents feel "right now," and Trait Anxiety Scale evaluating relatively stable aspects of "anxiety proneness". The STAI has 40 items, 20 items allocated to each subscale, with each item scored on a 4 point Likert scale. The subscale scores shown are averages of the items in the subscale ranging from 1.0 to 4.0, with a higher score indicating a greater level of anxiety.
Outcome measures
| Measure |
Standard Consent
n=72 Participants
This arm will receive the Consent Form Specific Format 1 'standard consent'. The standard consents are already approved and used for the BMT CTN 0901, 1101, 1203, and 1301 trials.
Consent Form Specific Format 1: The Consent Form Specific Format 1 is the 'Standard Consent'. The standard consent does not have the format of two-columns with changes in layout readability, organization of content, typography and use of plain language. Standard consents are already used by sites for the BMT CTN 0901, 1101, 1203, and 1301 clinical trials.
|
Easy-to-Read Informed Consent
n=80 Participants
This arm will receive the Consent Form Specific Format 2 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent (ETRIC) is the newly approved consent.
Consent Form Specific Format 2: The Consent Form Specific Format 2 is the 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent is two-columns with changes in layout readability, organization of content, typography and use of plain language.
|
|---|---|---|
|
State Trait Anxiety Inventory (STAI) Score
State Anxiety Scale
|
2.5 units on a scale
Interval 2.3 to 2.6
|
2.5 units on a scale
Interval 2.3 to 2.6
|
|
State Trait Anxiety Inventory (STAI) Score
Trait Anxiety Scale
|
2.4 units on a scale
Interval 2.2 to 2.5
|
2.3 units on a scale
Interval 2.1 to 2.5
|
SECONDARY outcome
Timeframe: Within 7 days of consent discussionPopulation: Participants completing the satisfaction questionnaire
A short study specific questionnaire and selected questions from the Quality of Informed Consent (QuIC) supplement questionnaire will query participants about their overall satisfaction with the consent process, helpfulness of information provided, and comprehension of key study-specific elements of treatment. Seven questions are included, each scored on a five point Likert scale. The overall score is the average of the item scores, ranging from 1.0 to 5.0, with a higher score indicating a higher level of satisfaction.
Outcome measures
| Measure |
Standard Consent
n=72 Participants
This arm will receive the Consent Form Specific Format 1 'standard consent'. The standard consents are already approved and used for the BMT CTN 0901, 1101, 1203, and 1301 trials.
Consent Form Specific Format 1: The Consent Form Specific Format 1 is the 'Standard Consent'. The standard consent does not have the format of two-columns with changes in layout readability, organization of content, typography and use of plain language. Standard consents are already used by sites for the BMT CTN 0901, 1101, 1203, and 1301 clinical trials.
|
Easy-to-Read Informed Consent
n=82 Participants
This arm will receive the Consent Form Specific Format 2 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent (ETRIC) is the newly approved consent.
Consent Form Specific Format 2: The Consent Form Specific Format 2 is the 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent is two-columns with changes in layout readability, organization of content, typography and use of plain language.
|
|---|---|---|
|
Participant Satisfaction With Consent Process
|
4.2 units on a scale
Interval 3.7 to 4.9
|
4.1 units on a scale
Interval 3.9 to 4.7
|
SECONDARY outcome
Timeframe: Within 7 days of consent discussionPopulation: Participants completing the information location assessment
Participants are asked to identify select items within the consent document and the time taken to locate items is measured. Patients who were not able to identify a given section were assigned the maximum time allotted to find each section (180 seconds).
Outcome measures
| Measure |
Standard Consent
n=76 Participants
This arm will receive the Consent Form Specific Format 1 'standard consent'. The standard consents are already approved and used for the BMT CTN 0901, 1101, 1203, and 1301 trials.
Consent Form Specific Format 1: The Consent Form Specific Format 1 is the 'Standard Consent'. The standard consent does not have the format of two-columns with changes in layout readability, organization of content, typography and use of plain language. Standard consents are already used by sites for the BMT CTN 0901, 1101, 1203, and 1301 clinical trials.
|
Easy-to-Read Informed Consent
n=85 Participants
This arm will receive the Consent Form Specific Format 2 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent (ETRIC) is the newly approved consent.
Consent Form Specific Format 2: The Consent Form Specific Format 2 is the 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent is two-columns with changes in layout readability, organization of content, typography and use of plain language.
|
|---|---|---|
|
Participant Information Location Time
Finding Main Goal for Study
|
22 seconds
Interval 11.0 to 60.0
|
30 seconds
Interval 11.0 to 63.0
|
|
Participant Information Location Time
Finding Who to Contact for Questions
|
15 seconds
Interval 7.0 to 34.0
|
20 seconds
Interval 10.0 to 45.0
|
|
Participant Information Location Time
Finding Risks and Benefits Section
|
20 seconds
Interval 14.0 to 30.0
|
20 seconds
Interval 10.0 to 40.0
|
|
Participant Information Location Time
Finding How to Leave the Study
|
24 seconds
Interval 15.0 to 60.0
|
30 seconds
Interval 11.0 to 60.0
|
|
Participant Information Location Time
Finding Study Procedures
|
43 seconds
Interval 21.0 to 83.0
|
36 seconds
Interval 18.0 to 96.0
|
SECONDARY outcome
Timeframe: Within 7 days of consent discussionPopulation: Consent rates are computed specific to each trial
The consent rate is the rate at which participants provided consent to participate in the parent trial.
Outcome measures
| Measure |
Standard Consent
n=98 Participants
This arm will receive the Consent Form Specific Format 1 'standard consent'. The standard consents are already approved and used for the BMT CTN 0901, 1101, 1203, and 1301 trials.
Consent Form Specific Format 1: The Consent Form Specific Format 1 is the 'Standard Consent'. The standard consent does not have the format of two-columns with changes in layout readability, organization of content, typography and use of plain language. Standard consents are already used by sites for the BMT CTN 0901, 1101, 1203, and 1301 clinical trials.
|
Easy-to-Read Informed Consent
n=100 Participants
This arm will receive the Consent Form Specific Format 2 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent (ETRIC) is the newly approved consent.
Consent Form Specific Format 2: The Consent Form Specific Format 2 is the 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent is two-columns with changes in layout readability, organization of content, typography and use of plain language.
|
|---|---|---|
|
Consent Rate on Parent Trial
BMT CTN 0901
|
2 Participants
|
3 Participants
|
|
Consent Rate on Parent Trial
BMT CTN 1101
|
13 Participants
|
10 Participants
|
|
Consent Rate on Parent Trial
BMT CTN 1203
|
22 Participants
|
25 Participants
|
|
Consent Rate on Parent Trial
BMT CTN 1501
|
9 Participants
|
7 Participants
|
Adverse Events
Standard Consent
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Easy-to-Read Informed Consent
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