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

Status: Active

Description

This trial studies cancer education and empowerment for preventing and controlling cancer in breast and ovarian cancer survivors and their families. Cancer education strategies, such as targeted generic print and tailored telephone counseling, may help survivors learn more about the risks for hereditary and ovarian breast cancer, as well as learning about current screening guidelines or other cancer prevention measures.

Eligibility Criteria

Inclusion Criteria

  • BREAST CANCER SURVIVORS: Hispanic or non-Hispanic
  • BREAST CANCER SURVIVORS: English or Spanish-speaking
  • BREAST CANCER SURVIVORS: Breast cancer history = breast cancer at the age or before age 50 OR triple negative breast cancer at or before age 60 OR two or more primary breast cancers
  • BREAST CANCER SURVIVORS: Primary cancer diagnosed (dx’ed) prior to breast cancer is OK
  • BREAST CANCER SURVIVORS: Primary tumor dx’ed after breast cancer is OK
  • OVARIAN CANCER SURVIVORS: Hispanic or non-Hispanic
  • OVARIAN CANCER SURVIVORS: English or Spanish-speaking
  • OVARIAN CANCER SURVIVORS: History of ovarian, fallopian, or peritoneal cancer diagnosed at any age
  • OVARIAN CANCER SURVIVORS: Primary cancer dx’ed prior to ovarian cancer is OK
  • OVARIAN CANCER SURVIVORS: Primary tumor dx’ed after ovarian cancer is OK

Exclusion Criteria

  • Have had prior genetic counseling or testing for hereditary breast and/or ovarian cancer
  • Not being able to speak or read English
  • Unable to give informed consent (incoherent, dementia)
  • No access to a telephone
  • In hospice care
  • Incarcerated
  • EXCLUSION CRITERIA FOR NEW JERSEY STATE CANCER REGISTRY (NJSCR) RECRUITMENT
  • Permanent residence outside of New Jersey (NJ)
  • Planning on relocating out of NJ within the next year
  • Currently enrolled in an active patient contact study with NJSCR-Cancer Surveillance Research Program (CSRP)

Locations & Contacts

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: Active
Contact: Anita Y. Kinney
Phone: 732-235-8871
Email: anita.kinney@rutgers.edu

New Mexico

Albuquerque
University of New Mexico Cancer Center
Status: Active
Contact: Jean Alison McDougall
Email: jamcdougall@salud.unm.edu

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Prevention

Lead Organization

Lead Organization
Rutgers Cancer Institute of New Jersey

Principal Investigator
Anita Y. Kinney

Trial IDs

Primary ID 131810
Secondary IDs NCI-2019-06318, Pro2018001350
Clinicaltrials.gov ID NCT03326713