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| Name | Class |
|---|---|
| Colorado Department of Public Health and Environment | OTHER_GOV |
| University of New Mexico | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telephone Counseling & Navigation (TCN) | Experimental | Telephone Counseling |
|
| Mailed Targeted Print (TP) | Active Comparator | Mailed Targeted Print |
|
| Usual Care (UC) | Other | Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone Counseling & Navigation (TCN) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months following the interventions for TP and TCN, and 6 months following the baseline survey for the UC arm. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months following the interventions for TP and TCN, and 12 months following the baseline survey for the UC arm. |
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Inclusion Criteria:
Breast Cancer
Hispanic or non-Hispanic
Female
21 years of age or older
English-speaking
Breast cancer history
Ovarian Cancer
Exclusion Criteria:
Have had prior genetic counseling or testing for hereditary breast and/or ovarian cancer
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| Name | Affiliation | Role |
|---|---|---|
| Anita Y Kinney, PhD, RN | Rutgers, The State University of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers University | New Brunswick | New Jersey | 08901 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38490263 | Derived | An J, McDougall J, Lin Y, Lu SE, Walters ST, Heidt E, Stroup A, Paddock L, Grumet S, Toppmeyer D, Kinney AY. Randomized trial promoting cancer genetic risk assessment when genetic counseling cost removed: 1-year follow-up. JNCI Cancer Spectr. 2024 Feb 29;8(2):pkae018. doi: 10.1093/jncics/pkae018. | |
| 36787512 | Derived |
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668 met inclusion criteria, were enrolled and randomized, and 658 received their assigned intervention.
Participants were recruited from 3 statewide cancer registries in New Jersey, Colorado, and New Mexico between November 2017 and July 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care (UC) | Included to assess CGRA uptake without intervention and to provide context for the primary outcome analysis. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-treat population: All randomized participants who remained eligible.
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care (UC) | Included to assess CGRA uptake without intervention and to provide context for the primary outcome analysis. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Eligible participants analyzed at 6 months. | Posted | Count of Participants | Participants | 6 months following the interventions for TP and TCN, and 6 months following the baseline survey for the UC arm. |
|
Time of enrollment through study completion, an average of 13 months.
The study is of minimal risk to participants. Adverse events were self-reported through surveys and during communications with research personnel.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care (UC) | Included to assess CGRA uptake without intervention and to provide context for the primary outcome analysis. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anita Y. Kinney, PhD | Rutgers Cancer Institute | (732) 865-3375 | anita.kinney@rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 6, 2024 | Apr 14, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 16, 2025 | Apr 14, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 7, 2022 | Aug 23, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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3-arm Randomized Controlled Trial
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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.
|
| Mailed Targeted Print (TP) | Behavioral | 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. |
|
| Usual Care (UC) | Other | 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. |
|
| 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. | 1 month following the interventions for TP and TCN, and 1 months following the baseline survey for the UC arm. |
| 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). | 1 month following the interventions for TP and TCN, and 1 months following the baseline survey for the UC arm. |
| Kinney AY, Walters ST, Lin Y, Lu SE, Kim A, Ani J, Heidt E, Le Compte CJG, O'Malley D, Stroup A, Paddock LE, Grumet S, Boyce TW, Toppmeyer DL, McDougall JA. Improving Uptake of Cancer Genetic Risk Assessment in a Remote Tailored Risk Communication and Navigation Intervention: Large Effect Size but Room to Grow. J Clin Oncol. 2023 May 20;41(15):2767-2778. doi: 10.1200/JCO.22.00751. Epub 2023 Feb 14. |
| 36518606 | Derived | Le Compte CG, Lu SE, Ani J, McDougall J, Walters ST, Toppmeyer D, Boyce TW, Stroup A, Paddock L, Grumet S, Lin Y, Heidt E, Kinney AY. Understanding cancer genetic risk assessment motivations in a remote tailored risk communication and navigation intervention randomized controlled trial. Health Psychol Behav Med. 2022 Dec 9;10(1):1190-1215. doi: 10.1080/21642850.2022.2150623. eCollection 2022. |
| 31650067 | Derived | Kinney AY, Blair CK, Guest DD, Ani JK, Harding EM, Amorim F, Boyce T, Rodman J, Ford CG, Schwartz M, Rosenberg L, Foran O, Gardner J, Lin Y, Arap W, Irwin MR. Biobehavioral effects of Tai Chi Qigong in men with prostate cancer: Study design of a three-arm randomized clinical trial. Contemp Clin Trials Commun. 2019 Aug 21;16:100431. doi: 10.1016/j.conctc.2019.100431. eCollection 2019 Dec. |
| 30236776 | Derived | Kinney AY, Howell R, Ruckman R, McDougall JA, Boyce TW, Vicuna B, Lee JH, Guest DD, Rycroft R, Valverde PA, Gallegos KM, Meisner A, Wiggins CL, Stroup A, Paddock LE, Walters ST. Promoting guideline-based cancer genetic risk assessment for hereditary breast and ovarian cancer in ethnically and geographically diverse cancer survivors: Rationale and design of a 3-arm randomized controlled trial. Contemp Clin Trials. 2018 Oct;73:123-135. doi: 10.1016/j.cct.2018.09.005. Epub 2018 Sep 18. |
| Withdrawal by Subject |
|
| Found Ineligible |
|
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Years Since Diagnosis | Number of years elapsed since a participant was diagnosed with cancer. | Mean | Standard Deviation | years |
|
| Annual Household Income | Total income earned by all members of a household within a year. | Count of Participants | Participants |
|
| Education Level | Participant highest completed level of education. | Count of Participants | Participants |
|
| Health Insurance | Whether a participant has health insurance coverage at the time of data collection. | Count of Participants | Participants |
|
| Cancer Site | Specific location or organ in the body where participant cancer originates. | Count of Participants | Participants |
|
| Language Preference | Participant preferred language for communication. | Count of Participants | Participants |
|
| Health Literacy Level | Assessed with a validated measure used to screen for people with inadequate health literacy. Response options are scored on a Likert scale of 0-4. Items are summed for a maximum health literacy score of 12. | Count of Participants | Participants |
|
| Family History of Cancer | Number of first-degree relatives (FDR) and second-degree relatives (SDR) with breast or ovarian cancer | Count of Participants | Participants |
|
| Marital Satus | Participant current marital status at time of data collection. | Count of Participants | Participants |
|
| Has a Personal Healthcare Provider | Whether participant has a designated personal healthcare provider, such as a primary care physician. | Count of Participants | Participants |
|
| Informed of Increased HBOC Risk by Healthcare Provider | Whether participant has been informed by a healthcare provider about their increased risk for hereditary breast and ovarian cancer (HBOC). | Count of Participants | 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. |
| OG002 | Tailored Counseling and 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. |
|
|
|
| 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. | Eligible participants analyzed at 12-months. | Posted | Count of Participants | Participants | 12 months following the interventions for TP and TCN, and 12 months following the baseline survey for the UC arm. |
|
|
|
| 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. | Eligible participants analyzed at 1 month. | Posted | Mean | Standard Deviation | score on a scale | 1 month following the interventions for TP and TCN, and 1 months following the baseline survey for the UC arm. |
|
|
|
| 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). | Eligible participants analyzed at 1 month. | Posted | Mean | Standard Deviation | units on a scale | 1 month following the interventions for TP and TCN, and 1 months following the baseline survey for the UC arm. |
|
|
|
| 2 |
| 223 |
| 0 |
| 223 |
| 0 |
| 223 |
| EG001 | Tailored 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. | 1 | 225 | 0 | 225 | 0 | 225 |
| EG002 | 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. | 0 | 220 | 0 | 220 | 0 | 220 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |