Cancer Education and Empowerment for Preventing and Controlling Cancer in Breast or Ovarian Cancer Survivors, The Grace Study

PRIMARY OBJECTIVE:

I. To compare the effectiveness of a usual care (UC) versus (vs.) targeted generic print (TP) vs. tailored telephone counseling and navigation intervention (TCN) on cancer genetic risk assessment (CGRA) uptake at 6 months for hereditary breast and ovarian cancer (HBOC).

SECONDARY OBJECTIVES:

I. To compare the effectiveness of a TP vs. a TCN intervention vs. UC on CGRA uptake at 12 months, after removal of key access barriers.

II. To compare uptake of genetic testing for HBOC across the three study arms at 6 and 12 months.

III. To compare cognitive (beliefs, attitudes, and knowledge) and affective (distress, stress, fear) intermediate endpoints among women in the three study arms and explore potential underlying theoretical mediating and moderating mechanisms that will further specify and elucidate significant intervention effects.

IV. To perform an economic evaluation alongside this randomized controlled trial to estimate the cost effectiveness of the two interventions compared to each other and usual care, for uptake of CGRA services from the societal and payer perspectives.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients receive usual care.

ARM II: Patients receive mailed materials about preventing and controlling cancer in families with a history of breast and/or ovarian cancer.

ARM III: Patients receive tailored telephone health education and navigation counseling over 15-45 minutes.

After completion of study, patients are followed up at 1, 6, and 12 months.