Clinical trial NCT01230346: Culturally-Informed Counseling in Latinas at High Risk for Hereditary Breast or Ovarian Cancer
Official title: Intervention to Promote Uptake of Cancer Risk Counseling for Underserved Latinas
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: No Evidence of Disease
BRCA1 Syndrome
BRCA2 Syndrome
Hereditary Female Breast Carcinoma
Hereditary Ovarian Carcinoma
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-10-29
Enrollment: 493
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: One week after genetic cancer risk assessment (GCRA)
measure: Experiences with the pre-GCRA intervention through post-intervention telephone interviews
timeFrame: One week after genetic cancer risk assessment (GCRA)
measure: Conduct a randomized controlled trial of a culturally-informed pre-GCRA telephone intervention utilizing AMI techniques
timeFrame: One week after genetic cancer risk assessment (GCRA)
Secondary outcomes:
measure: Perceived barriers to GCRA through no-show telephone interviews
timeFrame: One week after genetic cancer risk assessment (GCRA)
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California-Keck School of Medicine
state: California
city: Sylmar
country: United States
facility: Olive View-UCLA Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Bita Nehoray
role: PRINCIPAL_INVESTIGATOR
References: