Breast Cancer, Ovarian Cancer
Conditions
Keywords
Genetic Testing, Prevention
Brief summary
GRACE is a randomized 3-arm trial to determine the comparative effectiveness of two remote cancer communication interventions: 1) a targeted generic print (TP) or 2) a tailored telephone-based counseling and navigation intervention (TCN). Post-award, the target sample size was revised to (n=642) with NIH permission.
Detailed description
There is increasing evidence that activated and engaged patients who are equipped with necessary skills and information are more likely to follow through with recommended care and have better health outcomes at reduced costs. Identification of individuals at increased risk of hereditary breast and ovarian cancer (HBOC) is crucial for cancer survivors and their families to benefit from biomedical advances in cancer prevention, early detection, treatment and survivorship. The primary purpose of this study is to assess the feasibility and acceptability of two remote interventions aimed at promoting cancer genetic risk assessment (CGRA) for HBOC. The randomized controlled trial will have 3 arms: usual care (UC) vs. targeted generic print (TP) vs. tailored telephone counseling and navigation intervention (TCN).
Interventions
BEHAVIORALTelephone Counseling & Navigation (TCN)
A health coach will conduct a 30-45 minute telephone counseling session with participants. Prior to the telephone session, participants will receive the same brochure that the TP arm receives. After the phone call, participants will receive a tailored follow-up letter which will include images tailored to the individual's age, self-identified ethnicity, and family composition.
BEHAVIORALMailed Targeted Print (TP)
Participants will be mailed an educational brochure within two weeks of completing the baseline survey that addresses important evidence-based theoretical targets: CGRA guideline (knowledge), threat appraisal (to validate or raise risk perceptions, HBOC seriousness), response efficacy (benefits and expectations about CGRA), self-efficacy messages (CGRA resources, insurance reimbursement, and assistance for those with financial challenges) and possible actions to take (make an appointment and discuss with provider). Both the targeted print and tailored intervention materials were developed using formative community engaged research methods.
OTHERUsual Care (UC)
A usual care arm is included to assess CGRA uptake in the absence of intervention as well as priming from the surveys for the primary outcome analysis.
Sponsors
Rutgers, The State University of New Jersey
Colorado Department of Public Health and Environment
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Randomization will be single blinded. Research team members who are assessing the outcomes will be blinded to study arm assignment. Research staff who are conducting follow-up interviews will be blinded to group assignment as much as possible. At the beginning of the follow-up interviews, the interviewer will request that the participant does not reveal the study arm they were assigned to.
Intervention model description
3-arm Randomized Controlled Trial
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Breast Cancer * Hispanic or non-Hispanic * Female * 21 years of age or older * English-speaking * Breast cancer history * breast cancer at the age of 50 or younger OR * triple-negative breast cancer OR * two or more primary breast cancers Ovarian Cancer * Hispanic or non-Hispanic * Female * 21 years of age or older * English-speaking * History of ovarian, fallopian, or peritoneal cancer diagnosed at any age
Exclusion criteria
Have had prior genetic counseling or testing for hereditary breast and/or ovarian cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medically Verified Cancer Genetic Risk Assessment Uptake at 6 Months | 6 months following the interventions for TP and TCN, and 6 months following the baseline survey for the UC arm. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medically Verified Cancer Genetic Risk Assessment Uptake at 12 Months | 12 months following the interventions for TP and TCN, and 12 months following the baseline survey for the UC arm. | 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. |
| Decisional Conflict for CGRA: SURE Scale | 1 month following the interventions for TP and TCN, and 1 months following the baseline survey for the UC arm. | 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. |
| Cancer Genetic Risk Assessment Intention | 1 month following the interventions for TP and TCN, and 1 months following the baseline survey for the UC arm. | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnita Y Kinney, PhD, RN
Rutgers, The State University of New Jersey
Participant flow
Recruitment details
Participants were recruited from 3 statewide cancer registries in New Jersey, Colorado, and New Mexico between November 2017 and July 2020.
Pre-assignment details
668 met inclusion criteria, were enrolled and randomized, and 658 received their assigned intervention.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care (UC) Included to assess CGRA uptake without intervention and to provide context for the primary outcome analysis. | 212 |
| Mailed Targeted Print (TP) 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. | 214 |
| Tailored Counseling & Navigation (TCN) 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. | 212 |
| Total | 638 |
Baseline characteristics
| Characteristic | Mailed Targeted Print (TP) | Usual Care (UC) | Total | Tailored Counseling & Navigation (TCN) |
|---|---|---|---|---|
| Age, Continuous | 61.0 years STANDARD_DEVIATION 10.1 | 61.1 years STANDARD_DEVIATION 10 | 61.1 years STANDARD_DEVIATION 10.2 | 61.2 years STANDARD_DEVIATION 10.7 |
| Annual Household Income <$30,000 | 43 Participants | 51 Participants | 140 Participants | 46 Participants |
| Annual Household Income $30,000-$49,999 | 35 Participants | 35 Participants | 101 Participants | 31 Participants |
| Annual Household Income $50,000-$69,999 | 28 Participants | 29 Participants | 85 Participants | 28 Participants |
| Annual Household Income $70,000 or more | 84 Participants | 73 Participants | 240 Participants | 83 Participants |
| Annual Household Income Missing | 24 Participants | 24 Participants | 72 Participants | 24 Participants |
| Cancer Site Breast | 182 Participants | 176 Participants | 544 Participants | 186 Participants |
| Cancer Site Ovarian | 32 Participants | 36 Participants | 94 Participants | 26 Participants |
| Education Level Bachelor's degree or higher | 105 Participants | 88 Participants | 290 Participants | 97 Participants |
| Education Level Less than high school/High school grad/GED | 40 Participants | 43 Participants | 115 Participants | 32 Participants |
| Education Level Missing | 2 Participants | 1 Participants | 6 Participants | 3 Participants |
| Education Level Some college, associate degree, or vocational school | 67 Participants | 80 Participants | 227 Participants | 80 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 46 Participants | 55 Participants | 159 Participants | 58 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 165 Participants | 152 Participants | 467 Participants | 150 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 12 Participants | 4 Participants |
| Family History of Cancer 0 FDR and 0 SDR | 140 Participants | 131 Participants | 406 Participants | 135 Participants |
| Family History of Cancer 1 FDR or 1 SDR | 40 Participants | 49 Participants | 131 Participants | 42 Participants |
| Family History of Cancer 2 or more FDR/SDR | 34 Participants | 32 Participants | 101 Participants | 35 Participants |
| Has a Personal Healthcare Provider No does not have a personal healthcare provider | 8 Participants | 9 Participants | 26 Participants | 9 Participants |
| Has a Personal Healthcare Provider Yes has a personal healthcare provider | 206 Participants | 203 Participants | 612 Participants | 203 Participants |
| Health Insurance Does not have health insurance | 7 Participants | 15 Participants | 34 Participants | 12 Participants |
| Health Insurance Has health insurance | 207 Participants | 197 Participants | 602 Participants | 198 Participants |
| Health Insurance Missing | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Health Literacy Level Adequate (<9) | 208 Participants | 208 Participants | 624 Participants | 208 Participants |
| Health Literacy Level Marginal/Inadequate (greater than or equal to 9) | 5 Participants | 4 Participants | 13 Participants | 4 Participants |
| Health Literacy Level Missing | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Informed of Increased HBOC Risk by Healthcare Provider Missing | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Informed of Increased HBOC Risk by Healthcare Provider No | 130 Participants | 133 Participants | 385 Participants | 122 Participants |
| Informed of Increased HBOC Risk by Healthcare Provider Yes | 83 Participants | 79 Participants | 252 Participants | 90 Participants |
| Language Preference English | 211 Participants | 196 Participants | 611 Participants | 204 Participants |
| Language Preference Spanish | 3 Participants | 16 Participants | 27 Participants | 8 Participants |
| Marital Satus Married/Domestic partnership | 125 Participants | 136 Participants | 388 Participants | 127 Participants |
| Marital Satus Missing | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Marital Satus Single/Divorced/Separated/Widowed | 88 Participants | 76 Participants | 249 Participants | 85 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 9 Participants | 27 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 7 Participants | 39 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 15 Participants | 5 Participants | 25 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 19 Participants | 29 Participants | 79 Participants | 31 Participants |
| Race (NIH/OMB) White | 153 Participants | 160 Participants | 461 Participants | 148 Participants |
| Region of Enrollment United States Mid-Atlantic, United States | 59 Participants | 62 Participants | 184 Participants | 63 Participants |
| Region of Enrollment United States Southwest, United States | 99 Participants | 109 Participants | 320 Participants | 112 Participants |
| Region of Enrollment United States West, United States | 56 Participants | 41 Participants | 134 Participants | 37 Participants |
| Sex: Female, Male Female | 214 Participants | 212 Participants | 638 Participants | 212 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Years Since Diagnosis | 10.9 years STANDARD_DEVIATION 7.6 | 11.3 years STANDARD_DEVIATION 7.7 | 11.2 years STANDARD_DEVIATION 7.7 | 11.3 years STANDARD_DEVIATION 7.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 223 | 1 / 225 | 0 / 220 |
| other Total, other adverse events | 0 / 223 | 0 / 225 | 0 / 220 |
| serious Total, serious adverse events | 0 / 223 | 0 / 225 | 0 / 220 |
Outcome results
Primary
Medically Verified Cancer Genetic Risk Assessment Uptake 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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care (UC) | Medically Verified Cancer Genetic Risk Assessment Uptake at 6 Months | 5 Participants |
| Tailored Print (TP) | Medically Verified Cancer Genetic Risk Assessment Uptake at 6 Months | 6 Participants |
| Tailored Counseling and Navigation (TCN) | Medically Verified Cancer Genetic Risk Assessment Uptake at 6 Months | 32 Participants |
Comparison: Logistic Regression Model Results for Intervention Effects on CGRA Within 6 Months (TP vs TCN)p-value: <0.000195% CI: [2.5, 15.2]Regression, Logistic
Comparison: Logistic Regression Model Results for Intervention Effects on CGRA Within 6 Months (UC vs TCN)p-value: <0.000195% CI: [2.8, 19.4]Regression, Logistic
Comparison: Logistic Regression Model Results for Intervention Effects on CGRA Within 6 Months (UC vs TP)p-value: 1.295% CI: [0.4, 4]Regression, Logistic
Secondary
Cancer Genetic Risk Assessment Intention
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Cancer Genetic Risk Assessment Intention | 2.69 units on a scale | Standard Deviation 1.27 |
| Tailored Print (TP) | Cancer Genetic Risk Assessment Intention | 2.78 units on a scale | Standard Deviation 1.29 |
| Tailored Counseling and Navigation (TCN) | Cancer Genetic Risk Assessment Intention | 3.44 units on a scale | Standard Deviation 1.46 |
Secondary
Decisional Conflict for CGRA: SURE Scale
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care (UC) | Decisional Conflict for CGRA: SURE Scale | 2.44 score on a scale | Standard Deviation 2.11 |
| Tailored Print (TP) | Decisional Conflict for CGRA: SURE Scale | 2.55 score on a scale | Standard Deviation 1.79 |
| Tailored Counseling and Navigation (TCN) | Decisional Conflict for CGRA: SURE Scale | 3.33 score on a scale | Standard Deviation 1.16 |
Secondary
Medically Verified Cancer Genetic Risk Assessment Uptake 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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care (UC) | Medically Verified Cancer Genetic Risk Assessment Uptake at 12 Months | 23 Participants |
| Tailored Print (TP) | Medically Verified Cancer Genetic Risk Assessment Uptake at 12 Months | 21 Participants |
| Tailored Counseling and Navigation (TCN) | Medically Verified Cancer Genetic Risk Assessment Uptake at 12 Months | 45 Participants |