Trial Outcomes & Findings for Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) Project (NCT NCT03326713)
NCT ID: NCT03326713
Last Updated: 2025-05-28
Results Overview
Participants reported whether they had sought cancer CGRA (i.e. genetic counseling and/or testing) in surveys at the 6-month follow-up. Participants who reported receiving a CGRA were asked to provide written consent allowing research staff to obtain document of receipt of the genetic services.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
668 participants
Primary outcome timeframe
6 months following the interventions for TP and TCN, and 6 months following the baseline survey for the UC arm.
Results posted on
2025-05-28
Participant Flow
Participants were recruited from 3 statewide cancer registries in New Jersey, Colorado, and New Mexico between November 2017 and July 2020.
668 met inclusion criteria, were enrolled and randomized, and 658 received their assigned intervention.
Participant milestones
| Measure |
Usual Care (UC)
Included to assess CGRA uptake without intervention and to provide context for the primary outcome analysis.
|
Tailored Print (TP)
Mailed Targeted Print:
Participants received an educational brochure within two weeks of completing the baseline survey. This brochure addressed key evidence-based targets: CGRA guidelines, threat appraisal, response efficacy, self-efficacy messages, and actionable steps (e.g., making an appointment). The materials were developed through community-engaged research methods.
|
Tailored Counseling & Navigation (TCN)
Telephone Counseling:
A health coach conducted a 30-45 minute telephone counseling session with participants. Before the call, they received the same brochure as the TP arm. After the session, participants received a personalized follow-up letter featuring images tailored to their age, self-identified ethnicity, and family composition.
|
|---|---|---|---|
|
Overall Study
STARTED
|
223
|
225
|
220
|
|
Overall Study
Received Intervention
|
223
|
224
|
211
|
|
Overall Study
COMPLETED
|
189
|
190
|
168
|
|
Overall Study
NOT COMPLETED
|
34
|
35
|
52
|
Reasons for withdrawal
| Measure |
Usual Care (UC)
Included to assess CGRA uptake without intervention and to provide context for the primary outcome analysis.
|
Tailored Print (TP)
Mailed Targeted Print:
Participants received an educational brochure within two weeks of completing the baseline survey. This brochure addressed key evidence-based targets: CGRA guidelines, threat appraisal, response efficacy, self-efficacy messages, and actionable steps (e.g., making an appointment). The materials were developed through community-engaged research methods.
|
Tailored Counseling & Navigation (TCN)
Telephone Counseling:
A health coach conducted a 30-45 minute telephone counseling session with participants. Before the call, they received the same brochure as the TP arm. After the session, participants received a personalized follow-up letter featuring images tailored to their age, self-identified ethnicity, and family composition.
|
|---|---|---|---|
|
Overall Study
Death
|
2
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
20
|
21
|
33
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
11
|
|
Overall Study
Found Ineligible
|
11
|
11
|
8
|
Baseline Characteristics
Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) Project
Baseline characteristics by cohort
| Measure |
Usual Care (UC)
n=212 Participants
Included to assess CGRA uptake without intervention and to provide context for the primary outcome analysis.
|
Mailed Targeted Print (TP)
n=214 Participants
Mailed Targeted Print:
Participants receive an educational brochure within two weeks of completing the baseline survey. This brochure addresses key evidence-based targets: CGRA guidelines, threat appraisal, response efficacy, self-efficacy messages, and actionable steps (e.g., making an appointment). The materials were developed through community-engaged research methods.
|
Tailored Counseling & Navigation (TCN)
n=212 Participants
Telephone Counseling:
A health coach will conduct a 30-45 minute telephone counseling session with participants. Before the call, they will receive the same brochure as the TP arm. After the session, participants will receive a personalized follow-up letter featuring images tailored to their age, self-identified ethnicity, and family composition.
|
Total
n=638 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.1 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
61.0 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
61.2 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
61.1 years
STANDARD_DEVIATION 10.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
212 Participants
n=5 Participants
|
214 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
638 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
55 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
159 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
152 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
467 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
160 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
461 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
29 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Region of Enrollment
United States · Mid-Atlantic, United States
|
62 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
184 Participants
n=4 Participants
|
|
Region of Enrollment
United States · West, United States
|
41 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
134 Participants
n=4 Participants
|
|
Region of Enrollment
United States · Southwest, United States
|
109 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
320 Participants
n=4 Participants
|
|
Years Since Diagnosis
|
11.3 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
10.9 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
11.3 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
11.2 years
STANDARD_DEVIATION 7.7 • n=4 Participants
|
|
Annual Household Income
<$30,000
|
51 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
140 Participants
n=4 Participants
|
|
Annual Household Income
$30,000-$49,999
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
|
Annual Household Income
$50,000-$69,999
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Annual Household Income
$70,000 or more
|
73 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
240 Participants
n=4 Participants
|
|
Annual Household Income
Missing
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Education Level
Less than high school/High school grad/GED
|
43 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
|
Education Level
Some college, associate degree, or vocational school
|
80 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
227 Participants
n=4 Participants
|
|
Education Level
Bachelor's degree or higher
|
88 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
290 Participants
n=4 Participants
|
|
Education Level
Missing
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Health Insurance
Does not have health insurance
|
15 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Health Insurance
Has health insurance
|
197 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
602 Participants
n=4 Participants
|
|
Health Insurance
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Cancer Site
Ovarian
|
36 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Cancer Site
Breast
|
176 Participants
n=5 Participants
|
182 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
544 Participants
n=4 Participants
|
|
Language Preference
English
|
196 Participants
n=5 Participants
|
211 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
611 Participants
n=4 Participants
|
|
Language Preference
Spanish
|
16 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Health Literacy Level
Adequate (<9)
|
208 Participants
n=5 Participants
|
208 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
624 Participants
n=4 Participants
|
|
Health Literacy Level
Marginal/Inadequate (greater than or equal to 9)
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Health Literacy Level
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Family History of Cancer
0 FDR and 0 SDR
|
131 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
406 Participants
n=4 Participants
|
|
Family History of Cancer
1 FDR or 1 SDR
|
49 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
131 Participants
n=4 Participants
|
|
Family History of Cancer
2 or more FDR/SDR
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
|
Marital Satus
Single/Divorced/Separated/Widowed
|
76 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
249 Participants
n=4 Participants
|
|
Marital Satus
Married/Domestic partnership
|
136 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
388 Participants
n=4 Participants
|
|
Marital Satus
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Has a Personal Healthcare Provider
No does not have a personal healthcare provider
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Has a Personal Healthcare Provider
Yes has a personal healthcare provider
|
203 Participants
n=5 Participants
|
206 Participants
n=7 Participants
|
203 Participants
n=5 Participants
|
612 Participants
n=4 Participants
|
|
Informed of Increased HBOC Risk by Healthcare Provider
No
|
133 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
385 Participants
n=4 Participants
|
|
Informed of Increased HBOC Risk by Healthcare Provider
Yes
|
79 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
252 Participants
n=4 Participants
|
|
Informed of Increased HBOC Risk by Healthcare Provider
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 months following the interventions for TP and TCN, and 6 months following the baseline survey for the UC arm.Population: Eligible participants analyzed at 6 months.
Participants reported whether they had sought cancer CGRA (i.e. genetic counseling and/or testing) in surveys at the 6-month follow-up. Participants who reported receiving a CGRA were asked to provide written consent allowing research staff to obtain document of receipt of the genetic services.
Outcome measures
| Measure |
Usual Care (UC)
n=213 Participants
Included to assess CGRA uptake without intervention and to provide context for the primary outcome analysis.
|
Tailored Print (TP)
n=216 Participants
Mailed Targeted Print:
Participants received an educational brochure within two weeks of completing the baseline survey. This brochure addressed key evidence-based targets: CGRA guidelines, threat appraisal, response efficacy, self-efficacy messages, and actionable steps (e.g., making an appointment). The materials were developed through community-engaged research methods.
|
Tailored Counseling and Navigation (TCN)
n=212 Participants
Telephone Counseling:
A health coach conducted a 30-45 minute telephone counseling session with participants. Before the call, they received the same brochure as the TP arm. After the session, participants received a personalized follow-up letter featuring images tailored to their age, self-identified ethnicity, and family composition.
|
|---|---|---|---|
|
Medically Verified Cancer Genetic Risk Assessment Uptake at 6 Months
|
5 Participants
|
6 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 12 months following the interventions for TP and TCN, and 12 months following the baseline survey for the UC arm.Population: Eligible participants analyzed at 12-months.
Participants reported whether they had sought cancer CGRA (i.e. genetic counseling and/or testing) in surveys at the 12-month follow-up. Participants who reported receiving a CGRA were asked to provide written consent, allowing research staff to obtain documents of receipt of the genetic services.
Outcome measures
| Measure |
Usual Care (UC)
n=212 Participants
Included to assess CGRA uptake without intervention and to provide context for the primary outcome analysis.
|
Tailored Print (TP)
n=214 Participants
Mailed Targeted Print:
Participants received an educational brochure within two weeks of completing the baseline survey. This brochure addressed key evidence-based targets: CGRA guidelines, threat appraisal, response efficacy, self-efficacy messages, and actionable steps (e.g., making an appointment). The materials were developed through community-engaged research methods.
|
Tailored Counseling and Navigation (TCN)
n=212 Participants
Telephone Counseling:
A health coach conducted a 30-45 minute telephone counseling session with participants. Before the call, they received the same brochure as the TP arm. After the session, participants received a personalized follow-up letter featuring images tailored to their age, self-identified ethnicity, and family composition.
|
|---|---|---|---|
|
Medically Verified Cancer Genetic Risk Assessment Uptake at 12 Months
|
23 Participants
|
21 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: 1 month following the interventions for TP and TCN, and 1 months following the baseline survey for the UC arm.Population: Eligible participants analyzed at 1 month.
Questionnaire: Decisional conflict associated with the CGRA decision will be measured separately with 4 items using the SURE Scale (Sure of myself; Understand information; Risk-benefit ratio; Encouragement). Range from 0-4, with 0 indicating high decisional conflict.
Outcome measures
| Measure |
Usual Care (UC)
n=213 Participants
Included to assess CGRA uptake without intervention and to provide context for the primary outcome analysis.
|
Tailored Print (TP)
n=216 Participants
Mailed Targeted Print:
Participants received an educational brochure within two weeks of completing the baseline survey. This brochure addressed key evidence-based targets: CGRA guidelines, threat appraisal, response efficacy, self-efficacy messages, and actionable steps (e.g., making an appointment). The materials were developed through community-engaged research methods.
|
Tailored Counseling and Navigation (TCN)
n=212 Participants
Telephone Counseling:
A health coach conducted a 30-45 minute telephone counseling session with participants. Before the call, they received the same brochure as the TP arm. After the session, participants received a personalized follow-up letter featuring images tailored to their age, self-identified ethnicity, and family composition.
|
|---|---|---|---|
|
Decisional Conflict for CGRA: SURE Scale
|
2.44 score on a scale
Standard Deviation 2.11
|
2.55 score on a scale
Standard Deviation 1.79
|
3.33 score on a scale
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: 1 month following the interventions for TP and TCN, and 1 months following the baseline survey for the UC arm.Population: Eligible participants analyzed at 1 month.
Questionnaire: One item will measure future intention to get a cancer genetic risk assessment within the next 6 weeks. Responses for this item ranged from 1 (not at all) to 5 (extremely likely).
Outcome measures
| Measure |
Usual Care (UC)
n=213 Participants
Included to assess CGRA uptake without intervention and to provide context for the primary outcome analysis.
|
Tailored Print (TP)
n=216 Participants
Mailed Targeted Print:
Participants received an educational brochure within two weeks of completing the baseline survey. This brochure addressed key evidence-based targets: CGRA guidelines, threat appraisal, response efficacy, self-efficacy messages, and actionable steps (e.g., making an appointment). The materials were developed through community-engaged research methods.
|
Tailored Counseling and Navigation (TCN)
n=212 Participants
Telephone Counseling:
A health coach conducted a 30-45 minute telephone counseling session with participants. Before the call, they received the same brochure as the TP arm. After the session, participants received a personalized follow-up letter featuring images tailored to their age, self-identified ethnicity, and family composition.
|
|---|---|---|---|
|
Cancer Genetic Risk Assessment Intention
|
2.69 units on a scale
Standard Deviation 1.27
|
2.78 units on a scale
Standard Deviation 1.29
|
3.44 units on a scale
Standard Deviation 1.46
|
Adverse Events
Usual Care (UC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Tailored Print (TP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Tailored Counseling & Navigation (TCN)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place