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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by City of Hope Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01230346
First received: September 22, 2010
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

A culturally-informed intervention may be an effective method to help people learn more about their cancer risk.


Condition Intervention
Healthy, no Evidence of Disease
Hereditary Breast/Ovarian Cancer - BRCA1
Hereditary Breast/Ovarian Cancer - BRCA2
Other: questionnaire administration
Other: survey administration
Other: counseling intervention
Other: educational intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Intervention to Promote Uptake of Cancer Risk Counseling for Underserved Latinas

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • 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 [ Time Frame: One week after genetic cancer risk assessment (GCRA) ] [ Designated as safety issue: No ]
    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.

  • Experiences with the pre-GCRA intervention through post-intervention telephone interviews [ Time Frame: One week after genetic cancer risk assessment (GCRA) ] [ Designated as safety issue: No ]
  • Conduct a randomized controlled trial of a culturally-informed pre-GCRA telephone intervention utilizing AMI techniques [ Time Frame: One week after genetic cancer risk assessment (GCRA) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Perceived barriers to GCRA through no-show telephone interviews [ Time Frame: One week after genetic cancer risk assessment (GCRA) ] [ Designated as safety issue: No ]

Estimated Enrollment: 404
Study Start Date: September 2010
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive a culturally-informed adapted motivational interviewing telephone call.
Other: questionnaire administration
Ancillary studies
Other: survey administration
Ancillary studies
Other: counseling intervention
Telephone intervention
Other Name: counseling and communications studies
Other: educational intervention
Telephone intervention
Other Name: intervention, educational
Experimental: Arm II
Patients participate in a controlled condition comprising a health habits intervention group.
Other: questionnaire administration
Ancillary studies
Other: survey administration
Ancillary studies
Other: counseling intervention
Telephone intervention
Other Name: counseling and communications studies
Active Comparator: Arm III
Patients receive usual care comprising a standard scheduling phone call and proceed with normal GCRA process.
Other: questionnaire administration
Ancillary studies
Other: survey administration
Ancillary studies

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01230346

Locations
United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Jeffrey Ne Weitzel    800-826-4673    becomeapatient@coh.org   
Principal Investigator: Jeffrey Ne Weitzel         
University of Southern California-Keck School of Medicine Recruiting
Los Angeles, California, United States, 90033
Contact: Charite Ricker, MS, CGC    323-226-2289    ricker@usc.edu   
Principal Investigator: Charite Ricker, MS, CGC         
Olive View-UCLA Medical Center Recruiting
Sylmar, California, United States, 91342
Contact: Lori Viveros, MPH    818-364-3562    LViveros@mednet.ucla.edu   
Principal Investigator: Nancy Feldman, MD         
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Jeffrey Weitzel City of Hope Medical Center
  More Information

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01230346     History of Changes
Other Study ID Numbers: 08237, NCI-2010-01998
Study First Received: September 22, 2010
Last Updated: March 31, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on July 26, 2014