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

• Sponsor: Medical College of Wisconsin (Other)
• Overall Status: Completed
• CT.gov ID: NCT02081248
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH), National Cancer Institute (NCI) (NIH), Blood and Marrow Transplant Clinical Trials Network (Other), National Marrow Donor Program (Other)
• Enrollment: 198
• Locations: 23
• Arms: 2
• Actual Duration (Months): 32.1
• Patients Per Site: 8.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The study has two parts: (1) Randomized Study to evaluate the effectiveness of ETRIC, and (2) Evaluation Study to understand barriers to implementation of ETRIC.

Condition or Disease	Intervention/Treatment	Phase
Improve the Informed Consent Process	Other: Consent Form Specific Format 1; Other: Consent Form Specific Format 2	N/A

Detailed Description

A two-arm, randomized study will be conducted in patients about to undergo consent discussion for participation in two large, multicenter BMT CTN clinical trials. Once they agree to participate in this Easy-to-Read Informed Consent (ETRIC) study, they will go through the consent process for the parent trial using either a standard or the ETRIC consent form. The content of both forms will be similar but the ETRIC form will incorporate a two-column format with specific attention towards enhanced readability and processability. Following the consent discussion for the BMT CTN parent trial, patients will complete assessments of health literacy, comprehension of the parent trial and satisfaction and anxiety related to the consent process. These assessments will be completed within 7 business days of the consent discussion of the parent trial.

Notes: Enrollment on the BMT CTN 0901 trial (NCT01339910) was closed to further accrual on April 18, 2014. Enrollment on the BMT CTN 1203 trial (NCT02208037) completed accrual on May 13, 2016.

Study Design

• Study Type: Interventional
• Actual Enrollment: 198 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Easy-to-Read Informed Consent (ETRIC) for Hematopoietic Cell Transplantation Clinical Trials (BMT CTN #1205)
• Actual Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Aug 3, 2016
• Actual Study Completion Date: Aug 3, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Other: 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.
Experimental: 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.	Other: 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.

Outcome Measures

Primary Outcome Measures

1. Quality of Informed Consent Part A (QuIC-A) Score [Within 7 days of consent discussion]

   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.

Secondary Outcome Measures

1. Quality of Informed Consent Part B (QuIC-B) Score [Within 7 days of consent discussion]

   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.

2. Modified Deaconess Informed Consent Comprehension Test (DICCT) [WIthin 7 days of consent discussion]

   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.

3. REALM-R Score [Within 7 days of consent discussion]

   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.

4. Newest Vital Sign (NVS) Score [Within 7 days of consent discussion]

   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.

5. State Trait Anxiety Inventory (STAI) Score [Within 7 days of consent discussion]

   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.

6. Participant Satisfaction With Consent Process [Within 7 days of consent discussion]

   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.

7. Participant Information Location Time [Within 7 days of consent discussion]

   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).

8. Consent Rate on Parent Trial [Within 7 days of consent discussion]

   The consent rate is the rate at which participants provided consent to participate in the parent trial.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion and exclusion criteria for the ETRIC randomized study will be the same as the eligibility criteria for the BMT CTN parent studies. Please refer to BMTCTN0901 (NCT01339910) Reduced Intensity Regimen vs Myeloablative Regimen for Myeloid Leukemia or Myelodysplastic Syndrome, BMTCTN1101 (NCT01597778) Double Cord Versus Haploidentical, BMTCTN1203 (NCT02208037) Novel Approaches for Graft-versus-Host Disease Prevention Compared to Contemporary Controls, and BMTCTN1301 (NCT02345850) Calcineurin Inhibitor-Free Interventions for Prevention of Graft-versus-Host Disease for detailed eligibility criteria.

Notes: Enrollment on the BMT CTN 0901 trial (NCT01339910) was closed to further accrual on April 18, 2014. Enrollment on the BMT CTN 1203 trial (NCT02208037) completed accrual on May 13, 2016.

Additional inclusion criteria specific for the ETRIC study will include:

1. Adult patients (≥ 18 years)

2. Speaking and reading proficiency in English (as most of this study's instruments have not been translated and validated in languages other than English)

3. Willing and able to provide informed consent

4. Stated willingness to comply with study procedures and reporting requirements

Exclusion Criteria: N/A

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope National Medical Center	Duarte	California	United States	91010
2	University of Florida College of Medicine (Shands)	Gainesville	Florida	United States	32610-0277
3	Florida Hospital Cancer Institute	Orlando	Florida	United States	32804
4	H. Lee Moffitt Cancer Center	Tampa	Florida	United States	33624
5	Emory University	Atlanta	Georgia	United States	30322
6	BMT Program at Northside Hospital	Atlanta	Georgia	United States	30342
7	Loyola University Medical Center	Maywood	Illinois	United States	60153
8	University of Kansas	Lawrence	Kansas	United States	66045
9	Johns Hopkins University	Baltimore	Maryland	United States	21231
10	Karmanos Cancer Institute	Detroit	Michigan	United States	48201
11	University of Minnesota	Minneapolis	Minnesota	United States	55455
12	Mayo Clinic - Rochester	Rochester	Minnesota	United States	55905
13	Washington University/Barnes Jewish Hospital	Saint Louis	Missouri	United States	63110
14	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198
15	University of North Carolina Hospital at Chapel Hill	Chapel Hill	North Carolina	United States	27599
16	Duke University Medical Center	Durham	North Carolina	United States	27705
17	The Jewish Hospital BMT Program	Cincinnati	Ohio	United States	45236
18	University Hospitals of Cleveland/Case Western	Cleveland	Ohio	United States	44106
19	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
20	Ohio State/Arthur G. James Cancer Hospital	Columbus	Ohio	United States	43210
21	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania	United States	19104-3309
22	West Virginia University Hospital	Morgantown	West Virginia	United States	26506-9162
23	The Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

• Medical College of Wisconsin
• National Heart, Lung, and Blood Institute (NHLBI)
• National Cancer Institute (NCI)
• Blood and Marrow Transplant Clinical Trials Network
• National Marrow Donor Program

Investigators

• Study Director: Mary Horowitz, MD, Center for International Blood and Marrow Transplant Research

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Blood and Marrow Transplant Clinical Trials Network
• National Marrow Donor Program

Publications

None provided.

• Responsible Party: Medical College of Wisconsin
• ClinicalTrials.gov Identifier: NCT02081248
• Other Study ID Numbers: BMTCTN1205; 2U10HL069294-11; 5U24CA076518
• First Posted: Mar 7, 2014
• Last Update Posted: Jul 10, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes

Study Results

Participant Flow

Arm/Group Title	Standard Consent	Easy-to-Read Informed Consent
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

Baseline Characteristics

Arm/Group Title	Standard Consent	Easy-to-Read Informed Consent	Total
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 Participants	98	100	198
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	61	61	61
Sex: Female, Male (Count of Participants)
Female	45 45.9%	43 43%	88 44.4%
Male	53 54.1%	57 57%	110 55.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 5.1%	2 2%	7 3.5%
Not Hispanic or Latino	87 88.8%	94 94%	181 91.4%
Unknown or Not Reported	6 6.1%	4 4%	10 5.1%
Race/Ethnicity, Customized (Count of Participants)
White	85 86.7%	88 88%	173 87.4%
Black	7 7.1%	8 8%	15 7.6%
Other	2 2%	2 2%	4 2%
Unknown or Not Reported	4 4.1%	2 2%	6 3%
Annual Household Income (Count of Participants)
Less than $40,000	11 11.2%	19 19%	30 15.2%
$40,000-79,999	25 25.5%	20 20%	45 22.7%
$80,000 or More	22 22.4%	26 26%	48 24.2%
Unknown or Not Reported	40 40.8%	35 35%	75 37.9%
Education Level (Count of Participants)
High School or Less	20 20.4%	35 35%	55 27.8%
Post-high School, but Less than Graduate Degree	29 29.6%	27 27%	56 28.3%
Graduate Degree or More	15 15.3%	11 11%	26 13.1%
Other	5 5.1%	6 6%	11 5.6%
Unknown or Not Reported	29 29.6%	21 21%	50 25.3%
Parent Clinical Trial (Count of Participants)
BMT CTN 0901	10 10.2%	11 11%	21 10.6%
BMT CTN 1101	25 25.5%	22 22%	47 23.7%
BMT CTN 1203	50 51%	51 51%	101 51%
BMT CTN 1301	13 13.3%	16 16%	29 14.6%

Outcome Measures

1. Primary Outcome

Title	Quality of Informed Consent Part A (QuIC-A) Score
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

Outcome Measure Data

Analysis Population Description

Participants completing the QuIC-A assessment

Arm/Group Title	Standard Consent	Easy-to-Read Informed Consent
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.
Measure Participants	71	81
Mean (Standard Deviation) [units on a scale]	81.8 (9.5)	80.5 (8.7)

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
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
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

Outcome Measure Data

Analysis Population Description

Participants completing the QuIC-B assessment

Arm/Group Title	Standard Consent	Easy-to-Read Informed Consent
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.
Measure Participants	71	81
Median (Inter-Quartile Range) [units on a scale]	98.2	96.4

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
Statistical Test of Hypothesis	p-Value	0.39
	Comments	Testing performed at a significance level of 0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Secondary Outcome

Title	Modified Deaconess Informed Consent Comprehension Test (DICCT)
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

Outcome Measure Data

Analysis Population Description

Participants completing the modified DICCT assessment

Arm/Group Title	Standard Consent	Easy-to-Read Informed Consent
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.
Measure Participants	73	84
Median (Inter-Quartile Range) [units on a scale]	15	15

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
Statistical Test of Hypothesis	p-Value	0.17
	Comments	Testing was performed at a significance level of 0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Secondary Outcome

Title	REALM-R Score
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Consent	Easy-to-Read Informed Consent
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.
Measure Participants	98	100
Less Than 8	15 15.3%	17 17%
8	62 63.3%	69 69%
Not Completed	21 21.4%	14 14%

5. Secondary Outcome

Title	Newest Vital Sign (NVS) Score
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Consent	Easy-to-Read Informed Consent
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.
Measure Participants	98	100
Less Than 4	11 11.2%	16 16%
4	53 54.1%	52 52%
5	13 13.3%	18 18%
Not Completed	21 21.4%	14 14%

6. Secondary Outcome

Title	State Trait Anxiety Inventory (STAI) Score
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

Outcome Measure Data

Analysis Population Description

Participants completing the STAI assessment

Arm/Group Title	Standard Consent	Easy-to-Read Informed Consent
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.
Measure Participants	72	80
State Anxiety Scale	2.5	2.5
Trait Anxiety Scale	2.4	2.3

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
Statistical Test of Hypothesis	p-Value	0.21
	Comments	Testing was performed at a significance level of 0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

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
Statistical Test of Hypothesis	p-Value	0.25
	Comments	Testing was performed at a significance level of 0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

7. Secondary Outcome

Title	Participant Satisfaction With Consent Process
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

Outcome Measure Data

Analysis Population Description

Participants completing the satisfaction questionnaire

Arm/Group Title	Standard Consent	Easy-to-Read Informed Consent
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.
Measure Participants	72	82
Median (Inter-Quartile Range) [units on a scale]	4.2	4.1

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
Statistical Test of Hypothesis	p-Value	0.80
	Comments	Testing was performed at a significance level of 0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

8. Secondary Outcome

Title	Participant Information Location Time
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

Outcome Measure Data

Analysis Population Description

Participants completing the information location assessment

Arm/Group Title	Standard Consent	Easy-to-Read Informed Consent
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.
Measure Participants	76	85
Finding Main Goal for Study	22	30
Finding Who to Contact for Questions	15	20
Finding Risks and Benefits Section	20	20
Finding How to Leave the Study	24	30
Finding Study Procedures	43	36

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
Statistical Test of Hypothesis	p-Value	0.73
	Comments	Testing was performed at a significance level of 0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

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
Statistical Test of Hypothesis	p-Value	0.26
	Comments	Testing was performed at a significance level of 0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

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
Statistical Test of Hypothesis	p-Value	0.74
	Comments	Testing was performed at a significance level of 0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

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
Statistical Test of Hypothesis	p-Value	0.56
	Comments	Testing was performed at a significance level of 0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

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
Statistical Test of Hypothesis	p-Value	0.79
	Comments	Testing was performed at a significance level of 0.05
	Method	Wilcoxon (Mann-Whitney)
	Comments

9. Secondary Outcome

Title	Consent Rate on Parent Trial
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

Outcome Measure Data

Analysis Population Description

Consent rates are computed specific to each trial

Arm/Group Title	Standard Consent	Easy-to-Read Informed Consent
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.
Measure Participants	98	100
BMT CTN 0901	2 2%	3 3%
BMT CTN 1101	13 13.3%	10 10%
BMT CTN 1203	22 22.4%	25 25%
BMT CTN 1501	9 9.2%	7 7%

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
Statistical Test of Hypothesis	p-Value	1.00
	Comments	Testing was performed at a significance level of 0.05
	Method	Fisher Exact
	Comments

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
Statistical Test of Hypothesis	p-Value	0.77
	Comments	Testing was performed at a significance level of 0.05
	Method	Fisher Exact
	Comments

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
Statistical Test of Hypothesis	p-Value	0.69
	Comments	Testing was performed at a significance level of 0.05
	Method	Fisher Exact
	Comments

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
Statistical Test of Hypothesis	p-Value	0.26
	Comments	Testing was performed at a significance level of 0.05
	Method	Fisher Exact
	Comments

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard Consent		Easy-to-Read Informed Consent
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Standard Consent		Easy-to-Read Informed Consent
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

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.