Trial Outcomes & Findings for Testing Diet Intervention Versus Non-Diet Intervention for Management of Bowel Symptoms in Rectal Cancer Survivors (NCT NCT04205955)
NCT ID: NCT04205955
Last Updated: 2024-05-01
Results Overview
Will be measured by the Memorial Sloan-Kettering Cancer Center Bowel Function Instrument (BFI) total score. Score range 18-90. Higher scores indicate better bowel function. Will be conducted according to a modified intention-to-treat principle. Study arm differences in BFI at 18 weeks will be assessed by a linear regression model as a function of randomization assignment, BFI baseline value, and stratification factors.
COMPLETED
PHASE2
95 participants
At 18 weeks after randomization
2024-05-01
Participant Flow
95 participants were randomly assigned; 48 on the attention control arm and 47 on the intervention arm. Reasons for ineligibility include not completing run-in, withdraw of consent, and disease progression.
Participant milestones
| Measure |
Arm I (Diet Modification Coaching, Motivational Messages)
Patients receive diet modification coaching via telephone for 10 sessions over 30-60 minutes over 17 weeks. Patients also receive 3 motivational messages per week via email and/or text message beginning after session 6.
Dietary Intervention: Receive diet modification coaching via phone call
Message: Receive motivational messages via email and/or text message
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm II (Standard of Care, Motivational Messages)
Patients receive general healthy living education via telephone for 10 sessions over 30-60 minutes over 17 weeks. Patients also receive 3 motivational messages per week via email and/or text message beginning after session 6.
Best Practice: Receive healthy living education via phone call
Message: Receive motivational messages via email and/or text message
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
48
|
|
Overall Study
COMPLETED
|
47
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Testing Diet Intervention Versus Non-Diet Intervention for Management of Bowel Symptoms in Rectal Cancer Survivors
Baseline characteristics by cohort
| Measure |
Arm I (Diet Modification Coaching, Motivational Messages)
n=47 Participants
Patients receive diet modification coaching via telephone for 10 sessions over 30-60 minutes over 17 weeks. Patients also receive 3 motivational messages per week via email and/or text message beginning after session 6.
Dietary Intervention: Receive diet modification coaching via phone call
Message: Receive motivational messages via email and/or text message
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm II (Standard of Care, Motivational Messages)
n=46 Participants
Patients receive general healthy living education via telephone for 10 sessions over 30-60 minutes over 17 weeks. Patients also receive 3 motivational messages per week via email and/or text message beginning after session 6.
Best Practice: Receive healthy living education via phone call
Message: Receive motivational messages via email and/or text message
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.6 years
n=5 Participants
|
56.9 years
n=7 Participants
|
55.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
38 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Ethnicity
Hispanic
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity
Non-Hispanic
|
42 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Ethnicity
Unknown
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Highest Level of Education
Did not complete high school
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Highest Level of Education
Completed high school/GED/vocational/secretarial/business
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Highest Level of Education
Any college
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Highest Level of Education
Any graduate school
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
27.3 kg/m^2
n=5 Participants
|
27.6 kg/m^2
n=7 Participants
|
27.3 kg/m^2
n=5 Participants
|
|
Body Mass Index (BMI)
<18.5 kg/m^2 (Underweight)
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
18.5-<25 kg/m^2 (Normal weight)
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
25-<30 kg/m^2 (Overweight)
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
>=30 kg/m^2 (Obese)
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Smoking Status
Current
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Smoking Status
Former
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Smoking Status
Never
|
35 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Smoking Status
Unknown
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Current Marital Status
Divorced
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Current Marital Status
Married or partnered
|
34 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Current Marital Status
Single
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Current Marital Status
Widowed
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Any Change in Marital Status Since Diagnosis
Yes
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Any Change in Marital Status Since Diagnosis
No
|
46 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Adjusted Diet because of Surgery/ostomy
Yes
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Adjusted Diet because of Surgery/ostomy
No
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Time to Comfort with Diet after your Surgery/ostomy
Less than 1 month
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Time to Comfort with Diet after your Surgery/ostomy
1 to 12 months
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Time to Comfort with Diet after your Surgery/ostomy
More than 12 months
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Time to Comfort with Diet after your Surgery/ostomy
I am still not comfortable
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Time to Comfort with Diet after your Surgery/ostomy
Not Answered
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Time Since Diagnosis
|
23.6 months
n=5 Participants
|
22.3 months
n=7 Participants
|
23.3 months
n=5 Participants
|
|
Type of Cancer
Rectal
|
39 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Type of Cancer
Rectosigmoid colon
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Type of Cancer
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Prior Treatment: Chemotherapy
Yes
|
41 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Prior Treatment: Chemotherapy
No
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Prior Treatment: Radiation Therapy
Yes
|
33 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Prior Treatment: Radiation Therapy
No
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Prior Surgery: Anastomosis
Yes
|
24 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Prior Surgery: Anastomosis
No
|
23 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Prior Surgery: Ostomy
Yes
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Prior Surgery: Ostomy
No
|
41 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Prior Surgery: Temporary Ostomy and Re-anastomosis
Yes
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Prior Surgery: Temporary Ostomy and Re-anastomosis
No
|
30 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Time Since Surgery
|
15.9 months
n=5 Participants
|
13.6 months
n=7 Participants
|
14.0 months
n=5 Participants
|
|
Type of Low Anterior Resection Surgery
Abdominoperineal resection
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Type of Low Anterior Resection Surgery
Low anterior resection
|
42 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Type of Low Anterior Resection Surgery
Sigmoid colectomy
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
LAR Syndrome (LARS) Burden
Minor LARS
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
LAR Syndrome (LARS) Burden
Major LARS
|
35 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
LAR Syndrome (LARS) Burden
Not applicable, ostomy
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Zubrod Performance Status
0
|
37 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Zubrod Performance Status
1
|
8 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Zubrod Performance Status
2
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Zubrod Performance Status
Missing
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Current Medication: Antibiotics
Yes
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Current Medication: Antibiotics
No
|
47 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Current Medication: Antidiarrheal Medications
Yes
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Current Medication: Antidiarrheal Medications
No
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Current Medication: Medication for Constipation
Yes
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Current Medication: Medication for Constipation
No
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Current Medication: Probiotics
Yes
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Current Medication: Probiotics
No
|
36 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Used Alternative Therapies for Bowel Issues in Past 5 Months
Yes
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Used Alternative Therapies for Bowel Issues in Past 5 Months
No
|
42 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
AJCC clinical stage at diagnosis: T Stage
T1
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
AJCC clinical stage at diagnosis: T Stage
T2
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
AJCC clinical stage at diagnosis: T Stage
T3
|
33 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
AJCC clinical stage at diagnosis: T Stage
T4
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
AJCC clinical stage at diagnosis: T Stage
TX
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
AJCC Clinical Stage at Diagnosis: N Stage
N0
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
AJCC Clinical Stage at Diagnosis: N Stage
N1
|
14 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
AJCC Clinical Stage at Diagnosis: N Stage
N2
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
AJCC Clinical Stage at Diagnosis: N Stage
NX
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
AJCC Clinical Stage at Diagnosis: M Stage
M0
|
41 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
AJCC Clinical Stage at Diagnosis: M Stage
M1
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
AJCC Clinical Stage at Diagnosis: M Stage
MX
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
AJCC Clinical Stage at Diagnosis: M Stage
Missing
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 18 weeks after randomizationPopulation: 95 total participants were randomly assigned; 47 on the intervention arm and 46 on the attention control arm. 3 patients were deemed ineligible for missing assessments and for other ineligibility criteria. This leaves 46 participants on the intervention arm and 44 on the attention control arm.
Will be measured by the Memorial Sloan-Kettering Cancer Center Bowel Function Instrument (BFI) total score. Score range 18-90. Higher scores indicate better bowel function. Will be conducted according to a modified intention-to-treat principle. Study arm differences in BFI at 18 weeks will be assessed by a linear regression model as a function of randomization assignment, BFI baseline value, and stratification factors.
Outcome measures
| Measure |
Arm I (Diet Modification Coaching, Motivational Messages)
n=46 Participants
Patients receive diet modification coaching via telephone for 10 sessions over 30-60 minutes over 17 weeks. Patients also receive 3 motivational messages per week via email and/or text message beginning after session 6.
Dietary Intervention: Receive diet modification coaching via phone call
Message: Receive motivational messages via email and/or text message
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm II (Standard of Care, Motivational Messages)
n=44 Participants
Patients receive general healthy living education via telephone for 10 sessions over 30-60 minutes over 17 weeks. Patients also receive 3 motivational messages per week via email and/or text message beginning after session 6.
Best Practice: Receive healthy living education via phone call
Message: Receive motivational messages via email and/or text message
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Bowel Function
|
30.8 MSK-BFI score on a scale (range 18-90)
Interval 29.2 to 32.4
|
29.5 MSK-BFI score on a scale (range 18-90)
Interval 27.3 to 31.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to week 26Will describe using dietary, urgency, and frequency scales. Will be assessed by a repeated measures linear regression model as a function of randomization assignment, baseline value of the outcome, stratification factors, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to week 26LARS will be measured using the LARS Score. Will be assessed by a repeated measures linear regression model as a function of randomization assignment, baseline value of the outcome, stratification factors, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to week 26Will be measured by the City of Hope-Quality of Life-Colorectal Cancer. Will be assessed by a repeated measures linear regression model as a function of randomization assignment, baseline value of the outcome, stratification factors, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to week 26Will be based on the Healthy Eating Index 2015. Will be assessed by a repeated measures linear regression model as a function of randomization assignment, baseline value of the outcome, stratification factors, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to week 26Will be measured using a 10-item scale assessing motivation to change dietary behaviors in rectal cancer survivors. Will be assessed by a repeated measures linear regression model as a function of randomization assignment, baseline value of the outcome, stratification factors, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to week 26Will be measured using the Patient-Reported Outcomes Measurement Information System Self-Efficacy for Managing Symptoms - Short Form 4a. Will be assessed by a repeated measures linear regression model as a function of randomization assignment, baseline value of the outcome, stratification factors, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to week 26Will be measured using the International Positive and Negative Affect Schedule Short Form. Will be assessed by a repeated measures linear regression model as a function of randomization assignment, baseline value of the outcome, stratification factors, and visit. Robust standard errors will be estimated via generalized estimating equations to adjust for correlation between repeated outcome measures. The dependent variables will be transformed to approximate normality as appropriate.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to week 26Will be measured by the percentage of patients who successfully complete ("pass") the run-in period, and randomized. Accrual rates and feasibility will be summarized.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to week 18Will measure successful completion of intervention or attention control coaching calls. Adherence is defined as completing all five of sessions 1-5 and at least three of sessions 6-10 within 18 weeks after randomization. Study arm differences in adherence will be assessed by chi square tests.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to week 26Will be defined by completion of follow-up assessments in step 2, including those administered at follow-up site visits and the dietary recalls. Study arm differences in retention will be assessed by chi square tests.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to week 26Will be measured using the Acceptability of Intervention measure. Study program acceptability will be compared across arms via t-test.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Diet Modification Coaching, Motivational Messages)
Arm II (Standard of Care, Motivational Messages)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Palliative and End of Life Care Committee Statistician
SWOG Statistics and Data Management Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60