ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    BMT CTN 0901

Easy-to-Read Informed Consent (ETRIC) for Hematopoietic Cell Transplantation Clinical Trials (BMT CTN 1205)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02081248
Recruitment Status : Completed
First Posted : March 7, 2014
Results First Posted : June 1, 2018
Last Update Posted : June 1, 2018
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Cancer Institute (NCI)
Blood and Marrow Transplant Clinical Trials Network
National Marrow Donor Program
Information provided by (Responsible Party):
Medical College of Wisconsin

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition Improve the Informed Consent Process
Interventions Other: Consent Form Specific Format 1
Other: Consent Form Specific Format 2
Enrollment 198
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Consent Easy-to-Read Informed Consent
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 98 100
Completed 76 87
Not Completed 22 13
Arm/Group Title Standard Consent Easy-to-Read Informed Consent Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 98 100 198
Hide Baseline Analysis Population Description
Enrolled participants
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 98 participants 100 participants 198 participants
61
(27 to 73)
61
(21 to 76)
61
(21 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 100 participants 198 participants
Female
45
  45.9%
43
  43.0%
88
  44.4%
Male
53
  54.1%
57
  57.0%
110
  55.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 100 participants 198 participants
Hispanic or Latino
5
   5.1%
2
   2.0%
7
   3.5%
Not Hispanic or Latino
87
  88.8%
94
  94.0%
181
  91.4%
Unknown or Not Reported
6
   6.1%
4
   4.0%
10
   5.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 100 participants 198 participants
White
85
  86.7%
88
  88.0%
173
  87.4%
Black
7
   7.1%
8
   8.0%
15
   7.6%
Other
2
   2.0%
2
   2.0%
4
   2.0%
Unknown or Not Reported
4
   4.1%
2
   2.0%
6
   3.0%
Annual Household Income  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 100 participants 198 participants
Less than $40,000
11
  11.2%
19
  19.0%
30
  15.2%
$40,000-79,999
25
  25.5%
20
  20.0%
45
  22.7%
$80,000 or More
22
  22.4%
26
  26.0%
48
  24.2%
Unknown or Not Reported
40
  40.8%
35
  35.0%
75
  37.9%
Education Level  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 100 participants 198 participants
High School or Less
20
  20.4%
35
  35.0%
55
  27.8%
Post-high School, but Less than Graduate Degree
29
  29.6%
27
  27.0%
56
  28.3%
Graduate Degree or More
15
  15.3%
11
  11.0%
26
  13.1%
Other
5
   5.1%
6
   6.0%
11
   5.6%
Unknown or Not Reported
29
  29.6%
21
  21.0%
50
  25.3%
Parent Clinical Trial   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 100 participants 198 participants
BMT CTN 0901
10
  10.2%
11
  11.0%
21
  10.6%
BMT CTN 1101
25
  25.5%
22
  22.0%
47
  23.7%
BMT CTN 1203
50
  51.0%
51
  51.0%
101
  51.0%
BMT CTN 1301
13
  13.3%
16
  16.0%
29
  14.6%
[1]
Measure Description: Participants for the ETRIC (BMT CTN 1205) study were recruited from those that were potentially eligible for BMT CTN 0901, 1101, 1203, or 1301 (NCT01339910, NCT01597778, NCT02208037, and NCT02345850, respectively). The parent clinical trial is the BMT CTN trial for which the participant was potentially eligible.
1.Primary Outcome
Title Quality of Informed Consent Part A (QuIC-A) Score
Hide Description 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.
Time Frame Within 7 days of consent discussion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants completing the QuIC-A assessment
Arm/Group Title Standard Consent Easy-to-Read Informed Consent
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 71 81
Mean (Standard Deviation)
Unit of Measure: units on a scale
81.8  (9.5) 80.5  (8.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Consent, Easy-to-Read Informed Consent
Comments The null hypothesis is that there is no difference in comprehension of the parent clinical trial, as measured by the QuIC-A, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Mean QuIC-A scores were compared between arms, which should be approximately equal under the null hypothesis.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments Testing was performed at a significance level of 0.05
Method t-test, 2 sided
Comments Two-sample t-test comparing mean QuIC-A scores performed using 150 degrees of freedom
2.Secondary Outcome
Title Quality of Informed Consent Part B (QuIC-B) Score
Hide Description 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.
Time Frame Within 7 days of consent discussion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants completing the QuIC-B assessment
Arm/Group Title Standard Consent Easy-to-Read Informed Consent
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 71 81
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
98.2
(91.9 to 100.0)
96.4
(89.3 to 100.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Consent, Easy-to-Read Informed Consent
Comments The null hypothesis is that there is no difference in participants' perception of their comprehension of the parent clinical trial, as measured by the QuIC-B, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median QuIC-B scores were compared between arms, which should be approximately equal under the null hypothesis.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments Testing performed at a significance level of 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Modified Deaconess Informed Consent Comprehension Test (DICCT)
Hide Description 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.
Time Frame WIthin 7 days of consent discussion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants completing the modified DICCT assessment
Arm/Group Title Standard Consent Easy-to-Read Informed Consent
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 73 84
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
15
(13 to 17)
15
(14 to 17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Consent, Easy-to-Read Informed Consent
Comments The null hypothesis is that there is no difference in participants' comprehension of the parent clinical trial, as measured by the DICCT, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median DICCT scores were compared between arms, which should be approximately equal under the null hypothesis.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments Testing was performed at a significance level of 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title REALM-R Score
Hide Description The 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.
Time Frame Within 7 days of consent discussion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Consent Easy-to-Read Informed Consent
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 98 100
Measure Type: Count of Participants
Unit of Measure: Participants
Less Than 8
15
  15.3%
17
  17.0%
8
62
  63.3%
69
  69.0%
Not Completed
21
  21.4%
14
  14.0%
5.Secondary Outcome
Title Newest Vital Sign (NVS) Score
Hide Description The 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.
Time Frame Within 7 days of consent discussion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Consent Easy-to-Read Informed Consent
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 98 100
Measure Type: Count of Participants
Unit of Measure: Participants
Less Than 4
11
  11.2%
16
  16.0%
4
53
  54.1%
52
  52.0%
5
13
  13.3%
18
  18.0%
Not Completed
21
  21.4%
14
  14.0%
6.Secondary Outcome
Title State Trait Anxiety Inventory (STAI) Score
Hide Description 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.
Time Frame Within 7 days of consent discussion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants completing the STAI assessment
Arm/Group Title Standard Consent Easy-to-Read Informed Consent
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 72 80
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
State Anxiety Scale
2.5
(2.3 to 2.6)
2.5
(2.3 to 2.6)
Trait Anxiety Scale
2.4
(2.2 to 2.5)
2.3
(2.1 to 2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Consent, Easy-to-Read Informed Consent
Comments The null hypothesis is that there is no difference in participants' state anxiety, as measured by the STAI, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median state anxiety subscores of the STAI were compared between arms, which should be equal under the null hypothesis.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments Testing was performed at a significance level of 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard Consent, Easy-to-Read Informed Consent
Comments The null hypothesis is that there is no difference in participants' trait anxiety, as measured by the STAI, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median trait anxiety subscores of the STAI were compared between arms, which should be equal under the null hypothesis.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments Testing was performed at a significance level of 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Secondary Outcome
Title Participant Satisfaction With Consent Process
Hide Description 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.
Time Frame Within 7 days of consent discussion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants completing the satisfaction questionnaire
Arm/Group Title Standard Consent Easy-to-Read Informed Consent
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 72 82
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
4.2
(3.7 to 4.9)
4.1
(3.9 to 4.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Consent, Easy-to-Read Informed Consent
Comments The null hypothesis is that there is no difference in satisfaction with the consent process, as measured by a study-specific questionnaire, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median participant satisfaction scores were compared between arms, which should be equal under the null hypothesis.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments Testing was performed at a significance level of 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
8.Secondary Outcome
Title Participant Information Location Time
Hide Description 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).
Time Frame Within 7 days of consent discussion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants completing the information location assessment
Arm/Group Title Standard Consent Easy-to-Read Informed Consent
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 76 85
Median (Inter-Quartile Range)
Unit of Measure: seconds
Finding Main Goal for Study
22
(11 to 60)
30
(11 to 63)
Finding Who to Contact for Questions
15
(7 to 34)
20
(10 to 45)
Finding Risks and Benefits Section
20
(14 to 30)
20
(10 to 40)
Finding How to Leave the Study
24
(15 to 60)
30
(11 to 60)
Finding Study Procedures
43
(21 to 83)
36
(18 to 96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Consent, Easy-to-Read Informed Consent
Comments The null hypothesis is that there is no difference in the time required to find the main goal of the study between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find the main goal of the study was compared between arms, which should be equal under the null hypothesis.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments Testing was performed at a significance level of 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard Consent, Easy-to-Read Informed Consent
Comments The null hypothesis is that there is no difference in the time required to find who to contact for questions between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find who to contact for questions was compared between arms, which should be equal under the null hypothesis.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments Testing was performed at a significance level of 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Standard Consent, Easy-to-Read Informed Consent
Comments The null hypothesis is that there is no difference in the time required to find the risks and benefits section between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find the risks and benefits section was compared between arms, which should be equal under the null hypothesis.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments Testing was performed at a significance level of 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Standard Consent, Easy-to-Read Informed Consent
Comments The null hypothesis is that there is no difference in the time required to find how to leave the study between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find how to leave the study was compared between arms, which should be equal under the null hypothesis.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments Testing was performed at a significance level of 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Standard Consent, Easy-to-Read Informed Consent
Comments The null hypothesis is that there is no difference in the time required to find study procedures between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find study procedures was compared between arms, which should be equal under the null hypothesis.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments Testing was performed at a significance level of 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Consent Rate on Parent Trial
Hide Description The consent rate is the rate at which participants provided consent to participate in the parent trial.
Time Frame Within 7 days of consent discussion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Consent rates are computed specific to each trial
Arm/Group Title Standard Consent Easy-to-Read Informed Consent
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 98 100
Measure Type: Count of Participants
Unit of Measure: Participants
BMT CTN 0901 Number Analyzed 10 participants 11 participants
2
  20.0%
3
  27.3%
BMT CTN 1101 Number Analyzed 25 participants 22 participants
13
  52.0%
10
  45.5%
BMT CTN 1203 Number Analyzed 50 participants 51 participants
22
  44.0%
25
  49.0%
BMT CTN 1501 Number Analyzed 13 participants 16 participants
9
  69.2%
7
  43.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Consent, Easy-to-Read Informed Consent
Comments The null hypothesis is that there is no difference in the consent rates to BMT CTN 0901 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 0901 were compared between arms in participants considering enrollment, which should be equal under the null hypothesis.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments Testing was performed at a significance level of 0.05
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard Consent, Easy-to-Read Informed Consent
Comments The null hypothesis is that there is no difference in the consent rates to BMT CTN 1101 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 1101 were compared between arms in participants considering enrollment, which should be approximately equal under the null hypothesis.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.77
Comments Testing was performed at a significance level of 0.05
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Standard Consent, Easy-to-Read Informed Consent
Comments The null hypothesis is that there is no difference in the consent rates to BMT CTN 1203 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 1203 were compared between arms in participants considering enrollment, which should be approximately equal under the null hypothesis.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments Testing was performed at a significance level of 0.05
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Standard Consent, Easy-to-Read Informed Consent
Comments The null hypothesis is that there is no difference in the consent rates to BMT CTN 1301 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 1501 were compared between arms in participants considering enrollment, which should be approximately equal under the null hypothesis.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments Testing was performed at a significance level of 0.05
Method Fisher Exact
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Serious and Other (Not Including Serious) Adverse Events were not monitored.
 
Arm/Group Title Standard Consent Easy-to-Read Informed Consent
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Standard Consent Easy-to-Read Informed Consent
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standard Consent Easy-to-Read Informed Consent
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Consent Easy-to-Read Informed Consent
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Adam Mendizabal, PhD
Organization: The Emmes Corporation
Phone: 301-251-1161
Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02081248     History of Changes
Other Study ID Numbers: BMTCTN1205
2U10HL069294-11 ( U.S. NIH Grant/Contract )
5U24CA076518 ( U.S. NIH Grant/Contract )
First Submitted: October 30, 2013
First Posted: March 7, 2014
Results First Submitted: March 28, 2018
Results First Posted: June 1, 2018
Last Update Posted: June 1, 2018