Trial Outcomes & Findings for To Enhance Breast Cancer Survivorship of Asian Americans (NCT NCT02803593)

NCT ID: NCT02803593

Last Updated: 2022-06-29

Results Overview

The SCNS uses 57 items to measure how much help the respondent needs. Responses are given on a scale from 1 to 5 where 1 = no help is needed and 5 = high need for help. Total scores range from 57 to 285 and higher scores indicate greater need for help.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

199 participants

Primary outcome timeframe

Baseline, Month 1, Month 3

Results posted on

2022-06-29

Participant Flow

Participants were recruited from Duke University in Durham, North Carolina, USA, and Emory University in Atlanta, Georgia, USA. Participant enrollment began in June 2016 and all follow up was complete by June 9, 2021.

Participant milestones

Participant milestones
Measure
Control
Asian American breast cancer survivors randomized to use the information on breast cancer by the American Cancer Society (ACS). Participants were asked to use the online ACS resources for 3 months.
TICAA
Asian American breast cancer survivors randomized to use the TICAA intervention and the information by the ACS. The intervention is a technology-based information and coaching/support program to enhance survivorship experience of Asian American breast cancer survivors. Participants were asked to use the TICAA program for 3 months.
Overall Study
STARTED
95
104
Overall Study
Completed Month 1 Assessment
83
76
Overall Study
COMPLETED
78
69
Overall Study
NOT COMPLETED
17
35

Reasons for withdrawal

Reasons for withdrawal
Measure
Control
Asian American breast cancer survivors randomized to use the information on breast cancer by the American Cancer Society (ACS). Participants were asked to use the online ACS resources for 3 months.
TICAA
Asian American breast cancer survivors randomized to use the TICAA intervention and the information by the ACS. The intervention is a technology-based information and coaching/support program to enhance survivorship experience of Asian American breast cancer survivors. Participants were asked to use the TICAA program for 3 months.
Overall Study
Lost to Follow-up
17
35

Baseline Characteristics

Some participants did not provide their age.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control
n=95 Participants
Asian American breast cancer survivors randomized to use the information on breast cancer by the American Cancer Society (ACS). Participants were asked to use the online ACS resources for 3 months.
TICAA
n=104 Participants
Asian American breast cancer survivors randomized to use the TICAA intervention and the information by the ACS. The intervention is a technology-based information and coaching/support program to enhance survivorship experience of Asian American breast cancer survivors. Participants were asked to use the TICAA program for 3 months.
Total
n=199 Participants
Total of all reporting groups
Age, Continuous
53.14 years
STANDARD_DEVIATION 13.62 • n=93 Participants • Some participants did not provide their age.
51.60 years
STANDARD_DEVIATION 11.38 • n=98 Participants • Some participants did not provide their age.
52.35 years
STANDARD_DEVIATION 12.51 • n=191 Participants • Some participants did not provide their age.
Sex: Female, Male
Female
95 Participants
n=95 Participants
104 Participants
n=104 Participants
199 Participants
n=199 Participants
Sex: Female, Male
Male
0 Participants
n=95 Participants
0 Participants
n=104 Participants
0 Participants
n=199 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=95 Participants
0 Participants
n=104 Participants
0 Participants
n=199 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
95 Participants
n=95 Participants
104 Participants
n=104 Participants
199 Participants
n=199 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=95 Participants
0 Participants
n=104 Participants
0 Participants
n=199 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=95 Participants
0 Participants
n=104 Participants
0 Participants
n=199 Participants
Race (NIH/OMB)
Asian
95 Participants
n=95 Participants
104 Participants
n=104 Participants
199 Participants
n=199 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=95 Participants
0 Participants
n=104 Participants
0 Participants
n=199 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=95 Participants
0 Participants
n=104 Participants
0 Participants
n=199 Participants
Race (NIH/OMB)
White
0 Participants
n=95 Participants
0 Participants
n=104 Participants
0 Participants
n=199 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=95 Participants
0 Participants
n=104 Participants
0 Participants
n=199 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=95 Participants
0 Participants
n=104 Participants
0 Participants
n=199 Participants
Race/Ethnicity, Customized
Self-identified ethnicity · Chinese
52 Participants
n=95 Participants
36 Participants
n=104 Participants
88 Participants
n=199 Participants
Race/Ethnicity, Customized
Self-identified ethnicity · Korean
12 Participants
n=95 Participants
26 Participants
n=104 Participants
38 Participants
n=199 Participants
Race/Ethnicity, Customized
Self-identified ethnicity · Japanese
29 Participants
n=95 Participants
40 Participants
n=104 Participants
69 Participants
n=199 Participants
Race/Ethnicity, Customized
Self-identified ethnicity · Not reported
2 Participants
n=95 Participants
2 Participants
n=104 Participants
4 Participants
n=199 Participants
Region of Enrollment
United States
95 Participants
n=95 Participants
104 Participants
n=104 Participants
199 Participants
n=199 Participants
Education
High school graduation or less
33 Participants
n=95 Participants
21 Participants
n=104 Participants
54 Participants
n=199 Participants
Education
Completed undergraduate degree
47 Participants
n=95 Participants
62 Participants
n=104 Participants
109 Participants
n=199 Participants
Education
Completed graduate degree
15 Participants
n=95 Participants
21 Participants
n=104 Participants
36 Participants
n=199 Participants
Religion
No religion
42 Participants
n=95 Participants
47 Participants
n=104 Participants
89 Participants
n=199 Participants
Religion
Christian
36 Participants
n=95 Participants
44 Participants
n=104 Participants
80 Participants
n=199 Participants
Religion
Other
16 Participants
n=95 Participants
13 Participants
n=104 Participants
29 Participants
n=199 Participants
Religion
Not reported
1 Participants
n=95 Participants
0 Participants
n=104 Participants
1 Participants
n=199 Participants
Marital status
Married, partnered, or in a permanent relationship
70 Participants
n=95 Participants
73 Participants
n=104 Participants
143 Participants
n=199 Participants
Marital status
Single, divorced, or widowed
25 Participants
n=95 Participants
30 Participants
n=104 Participants
55 Participants
n=199 Participants
Marital status
Not reported
0 Participants
n=95 Participants
1 Participants
n=104 Participants
1 Participants
n=199 Participants
Employment status
Not employed
52 Participants
n=95 Participants
55 Participants
n=104 Participants
107 Participants
n=199 Participants
Employment status
Employed
34 Participants
n=95 Participants
38 Participants
n=104 Participants
72 Participants
n=199 Participants
Employment status
Not reported
9 Participants
n=95 Participants
11 Participants
n=104 Participants
20 Participants
n=199 Participants
Birthplace
United States
14 Participants
n=95 Participants
10 Participants
n=104 Participants
24 Participants
n=199 Participants
Birthplace
Other than United States
79 Participants
n=95 Participants
94 Participants
n=104 Participants
173 Participants
n=199 Participants
Birthplace
Not reported
2 Participants
n=95 Participants
0 Participants
n=104 Participants
2 Participants
n=199 Participants
Mean years living in United States
18.73 years
STANDARD_DEVIATION 12.61 • n=79 Participants • Years living in the United States was determined for participants who were born outside of the United States.
19.01 years
STANDARD_DEVIATION 11.42 • n=94 Participants • Years living in the United States was determined for participants who were born outside of the United States.
18.88 years
STANDARD_DEVIATION 11.95 • n=173 Participants • Years living in the United States was determined for participants who were born outside of the United States.
Age at immigration
36.92 years
STANDARD_DEVIATION 12.32 • n=79 Participants • Age at immigration was determined for participants who were born outside of the United States.
32.33 years
STANDARD_DEVIATION 12.53 • n=94 Participants • Age at immigration was determined for participants who were born outside of the United States.
34.46 years
STANDARD_DEVIATION 12.60 • n=173 Participants • Age at immigration was determined for participants who were born outside of the United States.
Acculturation score
3.55 score on a scale
STANDARD_DEVIATION 0.87 • n=79 Participants • This assessment was administered to participants who were born outside of the United States.
3.50 score on a scale
STANDARD_DEVIATION 0.74 • n=94 Participants • This assessment was administered to participants who were born outside of the United States.
3.52 score on a scale
STANDARD_DEVIATION 0.80 • n=173 Participants • This assessment was administered to participants who were born outside of the United States.
Years since diagnosis
3.73 years
STANDARD_DEVIATION 4.05 • n=95 Participants
3.58 years
STANDARD_DEVIATION 3.74 • n=104 Participants
3.65 years
STANDARD_DEVIATION 3.88 • n=199 Participants
Breast cancer type
Invasive
56 Participants
n=95 Participants
71 Participants
n=104 Participants
127 Participants
n=199 Participants
Breast cancer type
Non-invasive
28 Participants
n=95 Participants
27 Participants
n=104 Participants
55 Participants
n=199 Participants
Breast cancer type
Not reported
11 Participants
n=95 Participants
6 Participants
n=104 Participants
17 Participants
n=199 Participants
Breast cancer stage
Stage I
41 Participants
n=95 Participants
42 Participants
n=104 Participants
83 Participants
n=199 Participants
Breast cancer stage
Stage II/III
40 Participants
n=95 Participants
51 Participants
n=104 Participants
91 Participants
n=199 Participants
Breast cancer stage
Stage IV
4 Participants
n=95 Participants
4 Participants
n=104 Participants
8 Participants
n=199 Participants
Breast cancer stage
Unknown
6 Participants
n=95 Participants
5 Participants
n=104 Participants
11 Participants
n=199 Participants
Breast cancer stage
Not reported
4 Participants
n=95 Participants
2 Participants
n=104 Participants
6 Participants
n=199 Participants
Medical treatments
Radiation
44 Participants
n=95 Participants
47 Participants
n=104 Participants
91 Participants
n=199 Participants
Medical treatments
Chemotherapy
35 Participants
n=95 Participants
54 Participants
n=104 Participants
89 Participants
n=199 Participants
Medical treatments
Surgery
66 Participants
n=95 Participants
79 Participants
n=104 Participants
145 Participants
n=199 Participants
Medical treatments
Hormone
46 Participants
n=95 Participants
50 Participants
n=104 Participants
96 Participants
n=199 Participants
Medical treatments
Other
4 Participants
n=95 Participants
8 Participants
n=104 Participants
12 Participants
n=199 Participants

PRIMARY outcome

Timeframe: Baseline, Month 1, Month 3

Population: This analysis includes participants who completed the assessment at the indicated time points.

The SCNS uses 57 items to measure how much help the respondent needs. Responses are given on a scale from 1 to 5 where 1 = no help is needed and 5 = high need for help. Total scores range from 57 to 285 and higher scores indicate greater need for help.

Outcome measures

Outcome measures
Measure
Control
n=95 Participants
Asian American breast cancer survivors randomized to use the information on breast cancer by the American Cancer Society (ACS). Participants were asked to use the online ACS resources for 3 months.
TICAA
n=104 Participants
Asian American breast cancer survivors randomized to use the TICAA intervention and the information by the ACS. The intervention is a technology-based information and coaching/support program to enhance survivorship experience of Asian American breast cancer survivors. Participants were asked to use the TICAA program for 3 months.
Support Care Needs Survey (SCNS) Score
Baseline
84.15 score on a scale
Standard Deviation 28.77
85.01 score on a scale
Standard Deviation 29.44
Support Care Needs Survey (SCNS) Score
Month 1
79.27 score on a scale
Standard Deviation 27.21
78.20 score on a scale
Standard Deviation 23.94
Support Care Needs Survey (SCNS) Score
Month 3
77.20 score on a scale
Standard Deviation 25.95
78.33 score on a scale
Standard Deviation 22.71

PRIMARY outcome

Timeframe: Baseline, Month 1, Month 3

Population: This analysis includes participants who completed the assessment at the indicated time points.

Physical and psychological symptoms are assessed using the Memorial Symptom Assessment Scale-Short Form (MSAS-SF). The MSAS-SF asks if the respondent has experienced any of 32 specific symptoms during the past week, with the opportunity for the participant to enter additional symptoms. The degree of distress experienced by 28 of the symptoms is measured on a scale from 0 (not at all) to 4 (very much). The total score is the average of the responses to the distress scale items and and ranges from 0 to 4 with higher values indicating greater distress experienced from symptoms.

Outcome measures

Outcome measures
Measure
Control
n=95 Participants
Asian American breast cancer survivors randomized to use the information on breast cancer by the American Cancer Society (ACS). Participants were asked to use the online ACS resources for 3 months.
TICAA
n=104 Participants
Asian American breast cancer survivors randomized to use the TICAA intervention and the information by the ACS. The intervention is a technology-based information and coaching/support program to enhance survivorship experience of Asian American breast cancer survivors. Participants were asked to use the TICAA program for 3 months.
Memorial Symptom Assessment Scale-Short Form (MSAS-SF) Score
Baseline
1.68 score on a scale
Standard Deviation 0.46
1.84 score on a scale
Standard Deviation 0.55
Memorial Symptom Assessment Scale-Short Form (MSAS-SF) Score
Month 1
1.71 score on a scale
Standard Deviation 0.55
1.74 score on a scale
Standard Deviation 0.41
Memorial Symptom Assessment Scale-Short Form (MSAS-SF) Score
Month 3
1.69 score on a scale
Standard Deviation 0.47
1.66 score on a scale
Standard Deviation 0.39

PRIMARY outcome

Timeframe: Baseline, Month 1, Month 3

Population: This analysis includes participants who completed the assessment at the indicated time points.

Quality of life is assessed using the FACT-B. The FACT-B includes 41 items which are responded to on a scale from 0 to 4, where 0 = not at all and 4 = very much. The total score ranges from 0 to 164 and higher scores indicate better quality of life.

Outcome measures

Outcome measures
Measure
Control
n=95 Participants
Asian American breast cancer survivors randomized to use the information on breast cancer by the American Cancer Society (ACS). Participants were asked to use the online ACS resources for 3 months.
TICAA
n=104 Participants
Asian American breast cancer survivors randomized to use the TICAA intervention and the information by the ACS. The intervention is a technology-based information and coaching/support program to enhance survivorship experience of Asian American breast cancer survivors. Participants were asked to use the TICAA program for 3 months.
Functional Assessment of Cancer Therapy Scale-Breast Cancer (FACT-B) Score
Baseline
102.97 score on a scale
Standard Deviation 21.43
98.72 score on a scale
Standard Deviation 23.13
Functional Assessment of Cancer Therapy Scale-Breast Cancer (FACT-B) Score
Month 1
102.92 score on a scale
Standard Deviation 22.14
103.05 score on a scale
Standard Deviation 26.37
Functional Assessment of Cancer Therapy Scale-Breast Cancer (FACT-B) Score
Month 3
100.86 score on a scale
Standard Deviation 22.29
102.03 score on a scale
Standard Deviation 22.30

SECONDARY outcome

Timeframe: Baseline, Month 1, Month 3

Population: This analysis includes participants who completed the assessment at the indicated time points.

Attitudes related to breast cancer survivorship are measured using the Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS). The Attitudes section of this questionnaire includes 6 items scaled from -3 to 3, where -3 is the most negative score and 3 is the most positive score. There are also 7 qualitative questions. The total score for the scaled items ranges from -18 to 18 and higher scores indicate a better attitude towards breast cancer survivorship.

Outcome measures

Outcome measures
Measure
Control
n=95 Participants
Asian American breast cancer survivors randomized to use the information on breast cancer by the American Cancer Society (ACS). Participants were asked to use the online ACS resources for 3 months.
TICAA
n=104 Participants
Asian American breast cancer survivors randomized to use the TICAA intervention and the information by the ACS. The intervention is a technology-based information and coaching/support program to enhance survivorship experience of Asian American breast cancer survivors. Participants were asked to use the TICAA program for 3 months.
Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) Score for Attitudes
Baseline
-3.44 score on a scale
Standard Deviation 10.82
-0.57 score on a scale
Standard Deviation 10.21
Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) Score for Attitudes
Month 1
-3.15 score on a scale
Standard Deviation 9.66
-1.60 score on a scale
Standard Deviation 9.53
Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) Score for Attitudes
Month 3
-3.85 score on a scale
Standard Deviation 9.43
-1.76 score on a scale
Standard Deviation 8.84

SECONDARY outcome

Timeframe: Baseline, Month 1, Month 3

Population: This analysis includes participants who completed the assessment at the indicated time points.

Perceived barriers related to breast cancer survivorship are measured using the Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS). The Perceived Barriers section of this questionnaire includes 16 items where responses are given on a 4-point scale where 1 = never and 4 = always. Total scores range from 16 to 64 and higher scores indicate greater perceived barriers related to breast cancer survivorship.

Outcome measures

Outcome measures
Measure
Control
n=95 Participants
Asian American breast cancer survivors randomized to use the information on breast cancer by the American Cancer Society (ACS). Participants were asked to use the online ACS resources for 3 months.
TICAA
n=104 Participants
Asian American breast cancer survivors randomized to use the TICAA intervention and the information by the ACS. The intervention is a technology-based information and coaching/support program to enhance survivorship experience of Asian American breast cancer survivors. Participants were asked to use the TICAA program for 3 months.
Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) Score for Perceived Barriers
Month 1
28.00 score on a scale
Standard Deviation 8.12
29.48 score on a scale
Standard Deviation 8.54
Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) Score for Perceived Barriers
Month 3
29.05 score on a scale
Standard Deviation 7.97
28.65 score on a scale
Standard Deviation 8.12
Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) Score for Perceived Barriers
Baseline
27.49 score on a scale
Standard Deviation 8.45
30.50 score on a scale
Standard Deviation 9.57

SECONDARY outcome

Timeframe: Baseline, Month 1, Month 3

Population: This analysis includes participants who completed the assessment at the indicated time points.

Social influences related to breast cancer survivorship are measured using the Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS). The Social Influences section of this questionnaire includes 3 items where responses are given on a 7-point scale where 1 = disapproval from social support and 7 = approval from social support. Total scores range from 3 to 21 and higher scores indicate greater positive support from social influences.

Outcome measures

Outcome measures
Measure
Control
n=95 Participants
Asian American breast cancer survivors randomized to use the information on breast cancer by the American Cancer Society (ACS). Participants were asked to use the online ACS resources for 3 months.
TICAA
n=104 Participants
Asian American breast cancer survivors randomized to use the TICAA intervention and the information by the ACS. The intervention is a technology-based information and coaching/support program to enhance survivorship experience of Asian American breast cancer survivors. Participants were asked to use the TICAA program for 3 months.
Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) Score for Social Influences
Baseline
17.12 score on a scale
Standard Deviation 4.28
16.18 score on a scale
Standard Deviation 4.18
Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) Score for Social Influences
Month 1
17.19 score on a scale
Standard Deviation 3.82
16.39 score on a scale
Standard Deviation 4.14
Questions on Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS) Score for Social Influences
Month 3
16.32 score on a scale
Standard Deviation 4.23
16.82 score on a scale
Standard Deviation 3.71

SECONDARY outcome

Timeframe: Baseline, Month 1, Month 3

Population: This analysis includes participants who completed the assessment at the indicated time points.

Self-efficacy related to breast cancer survivorship is measured using the Cancer Behavior Inventory-Brief Version (CBI-B). The CBI-B has 12 items assessing the degree of confidence respondents have with certain coping behaviors on a scale from 1 (not at all confident) to 9 (totally confident). Total scores range from 12 to 108 where higher scores indicate greater self-efficacy concerning cancer behaviors.

Outcome measures

Outcome measures
Measure
Control
n=95 Participants
Asian American breast cancer survivors randomized to use the information on breast cancer by the American Cancer Society (ACS). Participants were asked to use the online ACS resources for 3 months.
TICAA
n=104 Participants
Asian American breast cancer survivors randomized to use the TICAA intervention and the information by the ACS. The intervention is a technology-based information and coaching/support program to enhance survivorship experience of Asian American breast cancer survivors. Participants were asked to use the TICAA program for 3 months.
Cancer Behavior Inventory-Brief Version (CBI-B) Score
Month 1
89.53 score on a scale
Standard Deviation 19.91
86.23 score on a scale
Standard Deviation 18.01
Cancer Behavior Inventory-Brief Version (CBI-B) Score
Baseline
86.04 score on a scale
Standard Deviation 21.14
84.53 score on a scale
Standard Deviation 22.00
Cancer Behavior Inventory-Brief Version (CBI-B) Score
Month 3
87.22 score on a scale
Standard Deviation 17.71
88.49 score on a scale
Standard Deviation 16.52

SECONDARY outcome

Timeframe: Baseline, Month 1, Month 3

Population: This analysis includes participants who completed the assessment at the indicated time points.

The Personal Resource Questionnaire (PRQ-2000) is a 15-item survey asking how much participants agree or disagree with statements related to social resources on a scale from 1 (strongly disagree) to 7 (strongly agree). Total scores range from 15 to 105 and higher scores indicate greater social resources.

Outcome measures

Outcome measures
Measure
Control
n=95 Participants
Asian American breast cancer survivors randomized to use the information on breast cancer by the American Cancer Society (ACS). Participants were asked to use the online ACS resources for 3 months.
TICAA
n=104 Participants
Asian American breast cancer survivors randomized to use the TICAA intervention and the information by the ACS. The intervention is a technology-based information and coaching/support program to enhance survivorship experience of Asian American breast cancer survivors. Participants were asked to use the TICAA program for 3 months.
Personal Resource Questionnaire (PRQ-2000) Score
Baseline
84.67 score on a scale
Standard Deviation 13.46
80.01 score on a scale
Standard Deviation 16.45
Personal Resource Questionnaire (PRQ-2000) Score
Month 1
84.14 score on a scale
Standard Deviation 12.99
80.47 score on a scale
Standard Deviation 14.23
Personal Resource Questionnaire (PRQ-2000) Score
Month 3
84.15 score on a scale
Standard Deviation 11.00
82.17 score on a scale
Standard Deviation 13.24

SECONDARY outcome

Timeframe: Baseline, Month 1, Month 3

Population: This analysis includes participants who completed the assessment at the indicated time points.

The Perceived Isolation Scale (PIS) includes 9 items asking questions about how social connectedness. Responses are rated on a 3-point scale where 1 = hardly ever, 2 = some of the time, and 3 = often. The total score is the average of the responses to the PIS items and ranges from 1 to 3 with lower scores indicating greater social connectedness.

Outcome measures

Outcome measures
Measure
Control
n=95 Participants
Asian American breast cancer survivors randomized to use the information on breast cancer by the American Cancer Society (ACS). Participants were asked to use the online ACS resources for 3 months.
TICAA
n=104 Participants
Asian American breast cancer survivors randomized to use the TICAA intervention and the information by the ACS. The intervention is a technology-based information and coaching/support program to enhance survivorship experience of Asian American breast cancer survivors. Participants were asked to use the TICAA program for 3 months.
Perceived Isolation Scale (PIS) Score
Baseline
1.61 score on a scale
Standard Deviation 0.34
1.73 score on a scale
Standard Deviation 0.47
Perceived Isolation Scale (PIS) Score
Month 1
1.62 score on a scale
Standard Deviation 0.38
1.70 score on a scale
Standard Deviation 0.38
Perceived Isolation Scale (PIS) Score
Month 3
1.62 score on a scale
Standard Deviation 0.39
1.68 score on a scale
Standard Deviation 0.40

Adverse Events

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

TICAA

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

Dr. Eun Ok Im

Emory University

Phone: 404-712-9805

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place