Trial Outcomes & Findings for Engaging and Activating Cancer Survivors in Genetic Services Study (NCT NCT04455698)
NCT ID: NCT04455698
Last Updated: 2026-08-12
Results Overview
Primary composite outcome collected via remote services records-Yes/No
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
511 participants
Primary outcome timeframe
Assessed at 6 Months for ARMS A/B/C
Results posted on
2026-08-12
Participant Flow
Participants were recruited by the Childhood Cancer Survivorship Study (CCSS) Coordinating Center at St. Jude between August 2021 and July 2023. Recruitment methods included emails, texts, phone calls, and mailings.
511 participants were consented and enrolled.
Participant milestones
| Measure |
Remote Telehealth Service: Video (ARM A)
Participants were offered standard of care pre-test and disclosure with a genetic counselor using videoconference in the home.
|
Remote Telehealth Service: Phone (ARM B)
Participants were offered standard of care pre-test and disclosure with a genetic counselor by telephone in the home.
|
Usual Care (ARM C) Only
Participants in the usual care arm received counseling and testing through usual care options in their region. After a 6-month status survey, if they had not had genetic services through usual care, they were offered services.
|
Usual Care (Arm C) Then Video (Arm A)
Participants in the usual care arm received counseling and testing through usual care options in their region. After a 6-month status survey, if they had not had genetic services through usual care, they were offered services and re-randomized to Arm A.
|
Usual Care (Arm C) Then Phone (Arm B)
Participants in the usual care arm received counseling and testing through usual care options in their region. After a 6-month status survey, if they had not had genetic services through usual care, they were offered services and re-randomized to Arm B.
|
|---|---|---|---|---|---|
|
Completed Baseline (T0) and Randomized
STARTED
|
189
|
189
|
99
|
17
|
17
|
|
Completed Baseline (T0) and Randomized
COMPLETED
|
171
|
181
|
95
|
17
|
17
|
|
Completed Baseline (T0) and Randomized
NOT COMPLETED
|
18
|
8
|
4
|
0
|
0
|
|
T1 Survey Following Pre-test Counseling
STARTED
|
188
|
198
|
0
|
0
|
0
|
|
T1 Survey Following Pre-test Counseling
COMPLETED
|
83
|
94
|
0
|
0
|
0
|
|
T1 Survey Following Pre-test Counseling
NOT COMPLETED
|
105
|
104
|
0
|
0
|
0
|
|
T2 Survey Post Genetic Testing
STARTED
|
83
|
94
|
0
|
0
|
0
|
|
T2 Survey Post Genetic Testing
COMPLETED
|
39
|
39
|
0
|
0
|
0
|
|
T2 Survey Post Genetic Testing
NOT COMPLETED
|
44
|
55
|
0
|
0
|
0
|
|
T3 Survey 6 Months Post Genetic Testing
STARTED
|
39
|
39
|
0
|
0
|
0
|
|
T3 Survey 6 Months Post Genetic Testing
COMPLETED
|
35
|
25
|
0
|
0
|
0
|
|
T3 Survey 6 Months Post Genetic Testing
NOT COMPLETED
|
4
|
14
|
0
|
0
|
0
|
|
T4 Survey 12 Months Post Genetic Testing
STARTED
|
35
|
25
|
0
|
0
|
0
|
|
T4 Survey 12 Months Post Genetic Testing
COMPLETED
|
32
|
20
|
0
|
0
|
0
|
|
T4 Survey 12 Months Post Genetic Testing
NOT COMPLETED
|
3
|
5
|
0
|
0
|
0
|
|
6 Month Assessment
STARTED
|
98
|
104
|
129
|
0
|
0
|
|
6 Month Assessment
COMPLETED
|
57
|
60
|
107
|
0
|
0
|
|
6 Month Assessment
NOT COMPLETED
|
41
|
44
|
22
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The number of participants analyzed for this characteristic are different than the number of baseline participants due to missing data.
Baseline characteristics by cohort
| Measure |
Remote Telehealth Service: Video (ARM A)
n=171 Participants
Participants were offered standard of care pre-test and disclosure with a genetic counselor using videoconference in the home.
|
Remote Telehealth Service: Phone (ARM B)
n=181 Participants
Participants were offered standard of care pre-test and disclosure with a genetic counselor by telephone in the home.
|
Usual Care (ARM C) Only
n=95 Participants
Participants in the usual care arm received counseling and testing through usual care options in their region. After a 6-month status survey, if they had not had genetic services through usual care, they were offered services.
|
Usual Care (ARM C) Then Video (Arm A)
n=17 Participants
Participants in the usual care arm received counseling and testing through usual care options in their region. After a 6-month status survey, if they had not had genetic services through usual care, they were offered services and re-randomized to Arm A.
|
Usual Care (ARM C) Then Phone (Arm B)
n=17 Participants
Participants in the usual care arm received counseling and testing through usual care options in their region. After a 6-month status survey, if they had not had genetic services through usual care, they were offered services and re-randomized to Arm B.
|
Total
n=481 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 9.8 • n=153 Participants • The number of participants analyzed for this characteristic are different than the number of baseline participants due to missing data.
|
43.8 years
STANDARD_DEVIATION 9.9 • n=160 Participants • The number of participants analyzed for this characteristic are different than the number of baseline participants due to missing data.
|
43.6 years
STANDARD_DEVIATION 9.6 • n=94 Participants • The number of participants analyzed for this characteristic are different than the number of baseline participants due to missing data.
|
44.5 years
STANDARD_DEVIATION 10.9 • n=17 Participants • The number of participants analyzed for this characteristic are different than the number of baseline participants due to missing data.
|
44.9 years
STANDARD_DEVIATION 9.1 • n=17 Participants • The number of participants analyzed for this characteristic are different than the number of baseline participants due to missing data.
|
44.2 years
STANDARD_DEVIATION 9.8 • n=441 Participants • The number of participants analyzed for this characteristic are different than the number of baseline participants due to missing data.
|
|
Sex: Female, Male
Female
|
96 Participants
n=171 Participants
|
98 Participants
n=181 Participants
|
51 Participants
n=95 Participants
|
10 Participants
n=17 Participants
|
7 Participants
n=17 Participants
|
262 Participants
n=481 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=171 Participants
|
83 Participants
n=181 Participants
|
44 Participants
n=95 Participants
|
7 Participants
n=17 Participants
|
10 Participants
n=17 Participants
|
219 Participants
n=481 Participants
|
|
Race/Ethnicity, Customized
White
|
128 Participants
n=171 Participants
|
132 Participants
n=181 Participants
|
78 Participants
n=95 Participants
|
12 Participants
n=17 Participants
|
14 Participants
n=17 Participants
|
364 Participants
n=481 Participants
|
|
Race/Ethnicity, Customized
Black
|
12 Participants
n=171 Participants
|
15 Participants
n=181 Participants
|
6 Participants
n=95 Participants
|
5 Participants
n=17 Participants
|
3 Participants
n=17 Participants
|
41 Participants
n=481 Participants
|
|
Race/Ethnicity, Customized
Other/Missing
|
31 Participants
n=171 Participants
|
34 Participants
n=181 Participants
|
11 Participants
n=95 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
76 Participants
n=481 Participants
|
|
First-degree/second-degree relative with cancer
|
1.9 Relatives with cancer
STANDARD_DEVIATION 1.6 • n=171 Participants
|
1.9 Relatives with cancer
STANDARD_DEVIATION 1.6 • n=181 Participants
|
1.5 Relatives with cancer
STANDARD_DEVIATION 1.1 • n=95 Participants
|
1.9 Relatives with cancer
STANDARD_DEVIATION 1.9 • n=17 Participants
|
1.9 Relatives with cancer
STANDARD_DEVIATION 1.8 • n=17 Participants
|
1.8 Relatives with cancer
STANDARD_DEVIATION 1.5 • n=481 Participants
|
PRIMARY outcome
Timeframe: Assessed at 6 Months for ARMS A/B/CPopulation: The number of participants who received genetic services
Primary composite outcome collected via remote services records-Yes/No
Outcome measures
| Measure |
Usual Care (ARM C)
n=129 Participants
Participants in the usual care arm received counseling and testing through usual care options in their region. After a 6-month status survey, if they had not had genetic services through usual care, they were offered services and re-randomized to Arm A or Arm B.
|
Remote Telehealth Service: Phone (ARM B)
n=198 Participants
Participants were offered standard of care pre-test and disclosure with a genetic counselor by telephone in the home.
|
Remote Telehealth Service: Video (ARM A)
n=188 Participants
Participants were offered standard of care pre-test and disclosure with a genetic counselor using videoconference in the home.
|
|---|---|---|---|
|
Number of Participants Who Received Genetic Services
|
19 Participants
|
94 Participants
|
83 Participants
|
PRIMARY outcome
Timeframe: Average time from baseline to disclosure was 152.3 days (standard deviation=150.0). (ARMS A/B only)Population: Survey not administered to participants in Arm C
Change in knowledge. Score range=0-16, and increased change score indicates increase in knowledge (better).
Outcome measures
| Measure |
Usual Care (ARM C)
Participants in the usual care arm received counseling and testing through usual care options in their region. After a 6-month status survey, if they had not had genetic services through usual care, they were offered services and re-randomized to Arm A or Arm B.
|
Remote Telehealth Service: Phone (ARM B)
n=30 Participants
Participants were offered standard of care pre-test and disclosure with a genetic counselor by telephone in the home.
|
Remote Telehealth Service: Video (ARM A)
n=35 Participants
Participants were offered standard of care pre-test and disclosure with a genetic counselor using videoconference in the home.
|
|---|---|---|---|
|
Genetic Knowledge Scale
|
—
|
1.80 score on a scale
Standard Deviation 2.72
|
1.82 score on a scale
Standard Deviation 3.06
|
PRIMARY outcome
Timeframe: Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days.(ARMS A/B only)Population: Survey not administered to participants in Arm C
Change in Cancer Specific Distress. Raw Score Range = 0-40. Decreased score change indicates a decrease in distress (better).
Outcome measures
| Measure |
Usual Care (ARM C)
Participants in the usual care arm received counseling and testing through usual care options in their region. After a 6-month status survey, if they had not had genetic services through usual care, they were offered services and re-randomized to Arm A or Arm B.
|
Remote Telehealth Service: Phone (ARM B)
n=30 Participants
Participants were offered standard of care pre-test and disclosure with a genetic counselor by telephone in the home.
|
Remote Telehealth Service: Video (ARM A)
n=35 Participants
Participants were offered standard of care pre-test and disclosure with a genetic counselor using videoconference in the home.
|
|---|---|---|---|
|
Impact of Events Scale (IES)
|
—
|
-0.29 score on a scale
Standard Deviation 7.70
|
-1.20 score on a scale
Standard Deviation 8.15
|
PRIMARY outcome
Timeframe: Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days.(ARMS A/B only)Population: Survey not administered to participants in Arm C
Change in Depression. Score Range = 4-20. Decreased score change indicates a decrease in depression (better).
Outcome measures
| Measure |
Usual Care (ARM C)
Participants in the usual care arm received counseling and testing through usual care options in their region. After a 6-month status survey, if they had not had genetic services through usual care, they were offered services and re-randomized to Arm A or Arm B.
|
Remote Telehealth Service: Phone (ARM B)
n=30 Participants
Participants were offered standard of care pre-test and disclosure with a genetic counselor by telephone in the home.
|
Remote Telehealth Service: Video (ARM A)
n=35 Participants
Participants were offered standard of care pre-test and disclosure with a genetic counselor using videoconference in the home.
|
|---|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)
|
—
|
-1.47 Score on a scale
Standard Deviation 2.34
|
-1.23 Score on a scale
Standard Deviation 2.20
|
SECONDARY outcome
Timeframe: 6 month status survey (ARMS A/B/C)The uptake of genetic services was obtained through available GC records for the telehealth genetic services arms. The 6-month post-enrollment survey was used for the usual care arm and for the telehealth genetic services arms when GC records did not indicate completion.
Outcome measures
| Measure |
Usual Care (ARM C)
n=129 Participants
Participants in the usual care arm received counseling and testing through usual care options in their region. After a 6-month status survey, if they had not had genetic services through usual care, they were offered services and re-randomized to Arm A or Arm B.
|
Remote Telehealth Service: Phone (ARM B)
n=198 Participants
Participants were offered standard of care pre-test and disclosure with a genetic counselor by telephone in the home.
|
Remote Telehealth Service: Video (ARM A)
n=188 Participants
Participants were offered standard of care pre-test and disclosure with a genetic counselor using videoconference in the home.
|
|---|---|---|---|
|
Uptake of Genetic Counseling and Testing
Uptake of genetic counseling
|
19 Participants
|
94 Participants
|
83 Participants
|
|
Uptake of Genetic Counseling and Testing
Uptake of genetic testing
|
12 Participants
|
39 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days (ARMS A/B only)Population: Survey not administered to participants in Arm C.
Change in Anxiety. Score Range = 4-20. Decreased score change indicates a decrease in anxiety (better).
Outcome measures
| Measure |
Usual Care (ARM C)
Participants in the usual care arm received counseling and testing through usual care options in their region. After a 6-month status survey, if they had not had genetic services through usual care, they were offered services and re-randomized to Arm A or Arm B.
|
Remote Telehealth Service: Phone (ARM B)
n=30 Participants
Participants were offered standard of care pre-test and disclosure with a genetic counselor by telephone in the home.
|
Remote Telehealth Service: Video (ARM A)
n=35 Participants
Participants were offered standard of care pre-test and disclosure with a genetic counselor using videoconference in the home.
|
|---|---|---|---|
|
Patient Reported Outcomes Measurement Information Systems (PROMIS) Anxiety
|
—
|
-1.77 score on a scale
Standard Deviation 2.31
|
-2.00 score on a scale
Standard Deviation 2.85
|
SECONDARY outcome
Timeframe: Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days (ARMS A/B only)Population: Survey not administered to participants in Arm C.
Change in Uncertainty. Score Range = 0-85. Decreased score change indicates a decrease in uncertainty (better).
Outcome measures
| Measure |
Usual Care (ARM C)
Participants in the usual care arm received counseling and testing through usual care options in their region. After a 6-month status survey, if they had not had genetic services through usual care, they were offered services and re-randomized to Arm A or Arm B.
|
Remote Telehealth Service: Phone (ARM B)
n=30 Participants
Participants were offered standard of care pre-test and disclosure with a genetic counselor by telephone in the home.
|
Remote Telehealth Service: Video (ARM A)
n=35 Participants
Participants were offered standard of care pre-test and disclosure with a genetic counselor using videoconference in the home.
|
|---|---|---|---|
|
Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA) Uncertainty
|
—
|
4.97 score on a scale
Standard Deviation 5.58
|
2.06 score on a scale
Standard Deviation 3.67
|
SECONDARY outcome
Timeframe: Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days (ARMS A/B only)Population: Survey not administered to participants in Arm C.
Change in performance of risk reductive and screening behaviors and communication of results from (Behavioral Risk Factor Surveillance System Questionnaire and Health/Diet Dietary Guidelines) - Yes/No responses.
Outcome measures
| Measure |
Usual Care (ARM C)
Participants in the usual care arm received counseling and testing through usual care options in their region. After a 6-month status survey, if they had not had genetic services through usual care, they were offered services and re-randomized to Arm A or Arm B.
|
Remote Telehealth Service: Phone (ARM B)
n=24 Participants
Participants were offered standard of care pre-test and disclosure with a genetic counselor by telephone in the home.
|
Remote Telehealth Service: Video (ARM A)
n=35 Participants
Participants were offered standard of care pre-test and disclosure with a genetic counselor using videoconference in the home.
|
|---|---|---|---|
|
Change in Health Behaviors: Change in Number of Wine/Beer/Mixed Drinks Per Day Among Those With Genetic Testing
|
—
|
-0.04 Number of drinks per day
Standard Deviation 1.20
|
0.00 Number of drinks per day
Standard Deviation 1.26
|
SECONDARY outcome
Timeframe: Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days (ARMS A/B only)Population: Survey not administered to participants in Arm C.
Change in performance of risk reductive and screening behaviors and communication of results from (Behavioral Risk Factor Surveillance System Questionnaire and Health/Diet Dietary Guidelines) - Yes/No responses.
Outcome measures
| Measure |
Usual Care (ARM C)
Participants in the usual care arm received counseling and testing through usual care options in their region. After a 6-month status survey, if they had not had genetic services through usual care, they were offered services and re-randomized to Arm A or Arm B.
|
Remote Telehealth Service: Phone (ARM B)
n=14 Participants
Participants were offered standard of care pre-test and disclosure with a genetic counselor by telephone in the home.
|
Remote Telehealth Service: Video (ARM A)
n=30 Participants
Participants were offered standard of care pre-test and disclosure with a genetic counselor using videoconference in the home.
|
|---|---|---|---|
|
Change in Health Behaviors: Change in Minutes of Vigorous Exercise Per Week Among Those With Genetic Testing
|
—
|
-70.50 Minutes per week
Standard Deviation 206.74
|
5.47 Minutes per week
Standard Deviation 53.39
|
SECONDARY outcome
Timeframe: Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days (ARMS A/B only)Population: Survey not administered to participants in Arm C.
Change in performance of ris k reductive and screening behaviors and communication of results from (Behavioral Risk Factor Surveillance System Questionnaire and Health/Diet Dietary Guidelines) - Yes/No responses.
Outcome measures
| Measure |
Usual Care (ARM C)
Participants in the usual care arm received counseling and testing through usual care options in their region. After a 6-month status survey, if they had not had genetic services through usual care, they were offered services and re-randomized to Arm A or Arm B.
|
Remote Telehealth Service: Phone (ARM B)
n=21 Participants
Participants were offered standard of care pre-test and disclosure with a genetic counselor by telephone in the home.
|
Remote Telehealth Service: Video (ARM A)
n=32 Participants
Participants were offered standard of care pre-test and disclosure with a genetic counselor using videoconference in the home.
|
|---|---|---|---|
|
Change in Health Behaviors: Change in Minutes of Moderate Exercise Per Week Among Those With Genetic Testing
|
—
|
-128.33 Minutes per week
Standard Deviation 465.28
|
-42.59 Minutes per week
Standard Deviation 294.58
|
SECONDARY outcome
Timeframe: Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days (ARMS A/B only)Population: Survey not administered to participants in Arm C.
Change in performance of risk reductive and screening behaviors and communication of results from (Behavioral Risk Factor Surveillance System Questionnaire and Health/Diet Dietary Guidelines) - Yes/No responses.
Outcome measures
| Measure |
Usual Care (ARM C)
Participants in the usual care arm received counseling and testing through usual care options in their region. After a 6-month status survey, if they had not had genetic services through usual care, they were offered services and re-randomized to Arm A or Arm B.
|
Remote Telehealth Service: Phone (ARM B)
n=35 Participants
Participants were offered standard of care pre-test and disclosure with a genetic counselor by telephone in the home.
|
Remote Telehealth Service: Video (ARM A)
n=32 Participants
Participants were offered standard of care pre-test and disclosure with a genetic counselor using videoconference in the home.
|
|---|---|---|---|
|
Change in Health Behaviors: New Sigmoidoscopy or Colonoscopy Among Those Who Did Not Have One Within a Year of the Baseline Visit
Not within 1 year at 6 months
|
—
|
34 Participants
|
30 Participants
|
|
Change in Health Behaviors: New Sigmoidoscopy or Colonoscopy Among Those Who Did Not Have One Within a Year of the Baseline Visit
Within 1 year at 6 months
|
—
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Average time from baseline to disclosure is 152.3 days, standard deviation = 150.0 days (ARMS A/B only)Population: Survey not administered to participants in Arm C.
Change in performance of risk reductive and screening behaviors and communication of results from (Behavioral Risk Factor Surveillance System Questionnaire and Health/Diet Dietary Guidelines) - Yes/No responses.
Outcome measures
| Measure |
Usual Care (ARM C)
Participants in the usual care arm received counseling and testing through usual care options in their region. After a 6-month status survey, if they had not had genetic services through usual care, they were offered services and re-randomized to Arm A or Arm B.
|
Remote Telehealth Service: Phone (ARM B)
n=35 Participants
Participants were offered standard of care pre-test and disclosure with a genetic counselor by telephone in the home.
|
Remote Telehealth Service: Video (ARM A)
n=32 Participants
Participants were offered standard of care pre-test and disclosure with a genetic counselor using videoconference in the home.
|
|---|---|---|---|
|
Change in Health Behaviors: New Mammogram Within One Year at 6 Months Among Those Who Did Not Have One Within a Year at Baseline
Not within 1 year at 6 months
|
—
|
32 Participants
|
30 Participants
|
|
Change in Health Behaviors: New Mammogram Within One Year at 6 Months Among Those Who Did Not Have One Within a Year at Baseline
Within 1 year at 6 months
|
—
|
3 Participants
|
2 Participants
|
Adverse Events
Remote Telehealth Service: Video (ARM A)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Remote Telehealth Service: Phone (ARM B)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care (ARM C)
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. Tara Henderson
Ann & Robert H. Lurie Children's Hospital of Chicago
Phone: (312) 227-4000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place