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

No Evidence of Disease Clinical Trial

Official title:

Intervention to Promote Uptake of Cancer Risk Counseling for Underserved Latinas

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01230346
• Other study ID #: 08237
• Secondary ID: NCI-2010-01998
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 3, 2010
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 493
• Est. completion date: December 31, 2024
• Est. primary completion date: November 10, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• questionnaire administration
Ancillary studies
• survey administration
Ancillary studies
• counseling intervention
Telephone intervention
• educational intervention
Telephone intervention

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California
United States	University of Southern California-Keck School of Medicine	Los Angeles	California
United States	Olive View-UCLA Medical Center	Sylmar	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of pre-GCRA intervention versus a time and attention control versus standard scheduling procedure alone (usual) on levels of anxiety, perceived personal control and cancer genetic knowledge	Tested using 3 x 3 repeated measures analysis of covariance (ANCOVA)s in which the within subjects variables are anxiety or perceived control, the between groups variable is group membership, and covariates include fatalism and other appropriate moderators.	One week after genetic cancer risk assessment (GCRA)
Primary	Experiences with the pre-GCRA intervention through post-intervention telephone interviews		One week after genetic cancer risk assessment (GCRA)
Primary	Conduct a randomized controlled trial of a culturally-informed pre-GCRA telephone intervention utilizing AMI techniques	Will use a multivariate ANCOVA (MANCOVA) to test for group differences among all five preparedness scores, with step-down F ratios of each individual score, using fatalism and other moderators as covariates, as appropriate.	One week after genetic cancer risk assessment (GCRA)
Secondary	Perceived barriers to GCRA through no-show telephone interviews		One week after genetic cancer risk assessment (GCRA)