NCT01230346

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

Intervention to Promote Uptake of Cancer Risk Counseling for Underserved Latinas

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 493 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• No Evidence of Disease
• BRCA1 Syndrome
• BRCA2 Syndrome
• Hereditary Female Breast Carcinoma
• Hereditary Ovarian Carcinoma

Interventions

Type	Name	Description
OTHER	questionnaire administration	Ancillary studies
OTHER	survey administration	Ancillary studies
OTHER	counseling intervention	Telephone intervention
OTHER	educational intervention	Telephone intervention

Timeline

• Start date: 2010-09-03
• Primary completion: 2016-11-10
• Completion: 2026-09-25
• First posted: 2010-10-29
• Last updated: 2025-11-10

Locations

3 sites across 1 country: United States