Culturally-Informed Counseling in Latinas at High Risk for Hereditary Breast or Ovarian Cancer

City of Hope

Status: Active, not recruiting

Conditions: Hereditary Ovarian Carcinoma; BRCA1 Syndrome; Hereditary Female Breast Carcinoma; BRCA2 Syndrome; No Evidence of Disease

Treatments: Other: educational intervention; Other: counseling intervention; Other: survey administration; Other: questionnaire administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01230346

NCI-2010-01998

08237

Details and patient eligibility

About

This pilot clinical trial studies a culturally-informed counseling intervention in Latinas at high risk for hereditary breast or ovarian cancer. A culturally-informed counseling intervention may be an effective method to help people learn more about their cancer risk.

Full description

PRIMARY OBJECTIVES:

I. To conduct a randomized trial of a culturally-informed pre-genetic cancer risk assessment (GCRA) telephone intervention.

II. To evaluate the effect of the pre-GCRA intervention versus a time and attention control versus standard scheduling procedure alone (usual care) on levels of anxiety, perceived personal control and cancer genetics knowledge.

III. To explore patients' experiences with the pre-GCRA intervention through post-intervention telephone interviews.

SECONDARY OBJECTIVES:

I. To explore patients' perceived barriers to GCRA through no-show telephone interviews.

OUTLINE:

Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive a culturally-informed adapted motivational interviewing telephone call.

ARM II: Patients participate in a controlled condition comprising a health habits intervention group.

ARM III: Patients receive usual care comprising a standard scheduling phone call and proceed with normal GCRA process. All patients are mailed standard new patient packets containing questionnaires on demographics and personal health history, and a family history form. All patients then undergo genetic cancer risk assessment.

Enrollment: 493 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Individuals who have a personal history of hereditary breast or ovarian cancer; a subset of 60 women without a personal history of hereditary or ovarian cancer will be included in an exploratory subset analysis
• Meet NCCN criteria for consideration of genetic testing for hereditary breast cancer
• Willing to sign consent
• Pregnant women and women of child-bearing potential are eligible for participation in this study
• Women who report themselves to be of Latino or Hispanic ethnic background (defined as Spanish, Mexican, Central or South American, Cuban, Puerto Rican, Dominican, or other Hispanic origin)
• Women who are under- or uninsured and come from low-income communities
• Ability to understand English or Spanish

Exclusion criteria

• Previous participation in GCRA

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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493 participants in 3 patient groups

Arm I

Experimental group

Description:

Patients receive a culturally-informed adapted motivational interviewing telephone call.

Treatment:

Other: questionnaire administration

Other: survey administration

Other: counseling intervention

Other: educational intervention

Arm II

Experimental group

Description:

Patients participate in a controlled condition comprising a health habits intervention group.

Treatment:

Other: questionnaire administration

Other: survey administration

Other: counseling intervention

Arm III

Active Comparator group

Description:

Patients receive usual care comprising a standard scheduling phone call and proceed with normal GCRA process.

Treatment:

Other: questionnaire administration

Other: survey administration