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Intervention to Promote Uptake of Cancer Risk Counseling for Underserved Latinas


N/A
18 Years
N/A
Open (Enrolling)
Female
Healthy, no Evidence of Disease, Hereditary Breast/Ovarian Cancer - BRCA1, Hereditary Breast/Ovarian Cancer - BRCA2

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Trial Information

Intervention to Promote Uptake of Cancer Risk Counseling for Underserved Latinas


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome 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

Outcome Description:

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.

Outcome Time Frame:

One week after genetic cancer risk assessment (GCRA)

Safety Issue:

No

Principal Investigator

Jeffrey Weitzel

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center

Authority:

United States: Federal Government

Study ID:

08237

NCT ID:

NCT01230346

Start Date:

September 2010

Completion Date:

Related Keywords:

  • Healthy, no Evidence of Disease
  • Hereditary Breast/Ovarian Cancer - BRCA1
  • Hereditary Breast/Ovarian Cancer - BRCA2
  • Ovarian Neoplasms

Name

Location

City of Hope Medical CenterDuarte, California  91010
University of Southern California-Keck School of MedicineLos Angeles, California  90033
Olive View-UCLA Medical CenterSylmar, California  91342