Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) Project (GRACE)

• ClinicalTrials.gov Identifier: NCT03326713
• Recruitment Status: Completed
• First Posted: October 31, 2017
• Last Update Posted: September 28, 2022
• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: Colorado Department of Public Health and Environment; University of New Mexico
• Information provided by (Responsible Party): Anita Y. Kinney, PhD, RN, Rutgers University

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Breast Cancer; Ovarian Cancer	Behavioral: Telephone Counseling & Navigation (TCN); Behavioral: Mailed Targeted Print (TP); Other: Usual Care (UC)	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 257 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 3-arm Randomized Controlled Trial
• Masking: Double (Investigator, 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.
• Primary Purpose: Prevention
• Official Title: Comparative Effectiveness of Interventions to Increase Guideline-based Genetic Counseling in Ethnically and Geographically Diverse Cancer Survivors
• Actual Study Start Date: October 1, 2016
• Actual Primary Completion Date: August 1, 2020
• Actual Study Completion Date: August 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Telephone Counseling & Navigation (TCN); Telephone Counseling	Behavioral: Telephone Counseling & Navigation (TCN); A health coach will conduct a 15-30 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.
Active Comparator: Mailed Targeted Print (TP); Mailed Targeted Print	Behavioral: Mailed 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.
Usual Care (UC); Control	Other: Usual 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.

Outcome Measures

Primary Outcome Measures :

1. Cancer Genetic Risk Assessment (Genetic Counseling) CGRA [ Time Frame: 1 month, 6 months, and 12 months ]
   Questionnaire: Participants will be asked whether they have had CGRA, the provider who conducted the CGRA, and the provider's genetics training. CGRA will be medical record verified delivered by the 6-month follow-up.

Secondary Outcome Measures :

1. Decisional conflict for CGRA: SURE Scale [ Time Frame: 1 month; 6 months; or 12 months ]
   Questionnaire: Decisional conflict associated with the CGRA decision will be measured separately with 4 items using the SURE Scale. Range from 0-4, with 0 indicating high decisional conflict.
2. Cancer Genetic Risk Assessment Intention [ Time Frame: Baseline; 1 month; 6 months; or 12 months ]
   Questionnaire: One item will measure future intention to get cancer genetic risk assessment. In follow up surveys, this will only be asked if participant does not report uptake of CGRA
3. HBOC Genetic Testing Intention [ Time Frame: Baseline; 1 month; 6 months; or 12 months ]
   Questionnaire: One item will measure future intention to get genetic testing for HBOC. In follow up surveys, this will only be asked if participant does not report uptake of genetic testing
4. HBOC Genetic Testing Uptake [ Time Frame: 1 month; 6 months; or 12 months ]
   Questionnaire: Participants will be asked if they received the intervention brochure and had telephone coaching. If yes, they will be asked questions regarding their reaction to the intervention.
5. Decisional conflict for HBOC genetic testing: Low Literacy Decisional Conflict Scale (DCS) SURE Scale [ Time Frame: 6 months; or 12 months ]
   Questionnaire: Decisional conflict associated with the HBOC gene test decision will be measured separately with 4 items using the SURE SCALE. Sum the four responses. Range from 0-4, with 0 indicating high decisional conflict.
6. Decisional satisfaction with CGRA: Satisfaction with Decision Instrument [ Time Frame: 6 months; or 12 months ]
   Questionnaire: Decisional satisfaction will be assessed using the Satisfaction with Decision Instrument. Five questions assess their personal satisfaction with their decision and two additional items assess how they feel about their CGRA decision in relation to their family. Satisfaction Score: Range 5-25, with 25 indicating high decisional satisfaction. Family Score: Range 2-10, with 10 indicating high consistency with personal values.
7. Decision Regret Scale [ Time Frame: 6 months; or 12 months ]
   Questionnaire: Five items will ask about regret regarding the decision to have or not have CGRA. Range from 0-100, with 100 indicating high decisional regret.
8. CGRA and HBOC Genetic Testing Facilitators [ Time Frame: Baseline; 1 month; 6 months; or 12 months ]
   Questionnaire: Facilitators include but are not limited to: help from family, desire to reduce risk of second cancers, and help/referrals from medical professionals.
9. Cost Data [ Time Frame: 6 Months and 12 months ]
   Questionnaire: Several items will be used to conduct a cost analysis in terms of costs to participants. These questions were developed for the purpose of this study and include out-of-pocket costs.
10. Physician/Health Care Provider Recommendation and Communication [ Time Frame: Baseline; 1 month; 6 months; or 12 months ]
    Questionnaire: Will assess whether healthcare providers have discussed participant's risk of HBOC and CGRA, and how participants feel discussing genetic testing with health care provider.

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion

Breast cancer survivor eligibility:

• Inclusion
• 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

Exclusion

• Have had prior genetic counseling or testing for hereditary breast and/or

Ovarian cancer survivor eligibility:

• Inclusion
• 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

• Have had prior genetic counseling or testing for hereditary breast and/or ovarian cancer

Contacts and Locations

Locations

United States, New Jersey

Rutgers University

New Brunswick, New Jersey, United States, 08901

Sponsors and Collaborators

Rutgers, The State University of New Jersey

Colorado Department of Public Health and Environment

University of New Mexico

Investigators

• Principal Investigator: Anita Y Kinney, PhD, RN; Rutgers, The State University of New Jersey

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Anita Y. Kinney, PhD, RN, Study Principal Investigator; Associate Director for Cancer Health Equity, Rutgers University
• ClinicalTrials.gov Identifier: NCT03326713
• Other Study ID Numbers: Pro2018001350
• First Posted: October 31, 2017
• Last Update Posted: September 28, 2022
• Last Verified: September 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anita Y. Kinney, PhD, RN, Rutgers University:

Genetic Testing; Prevention