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

This study is currently recruiting participants.
Verified March 2013 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 6, 2013
Last verified: March 2013

September 22, 2010
March 6, 2013
September 2010
September 2015   (final data collection date for primary 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 [ 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.
GCRA Appointment Adherence [ Time Frame: At Genetic cancer risk assessment (GCRA) consultation, 2-4 weeks after referral from PCP (Primary Care Physician) ] [ Designated as safety issue: No ]
Determine if a culturally informed pre-GCRA telephone intervention, guided by adapted motivational interviewing theory, can improve the uptake, preparedness for, and effectiveness of GCRA for underserved Latinas at high risk for hereditary breast and ovarian cancer.
Complete list of historical versions of study NCT01230346 on ClinicalTrials.gov Archive Site
Perceived barriers to GCRA through no-show telephone interviews [ Time Frame: One week after genetic cancer risk assessment (GCRA) ] [ Designated as safety issue: No ]
  • Pre-GCRA intervention effect on level of anxiety [ Time Frame: One week after genetic cancer risk assessment (GCRA) ] [ Designated as safety issue: No ]
    Evaluation of pre-GCRA intervention (culturally-informed motivational interview phone call) vs. control condition (health habit phone call) vs. scheduling alone (usual care) on level of anxiety.
  • Pre-GCRA intervention effect on level of perceived personal control [ Time Frame: One week after genetic cancer risk assessment (GCRA) ] [ Designated as safety issue: No ]
    Evaluation of pre-GCRA intervention (culturally-informed motivational interview phone call) vs. control condition (health habit phone call) vs. scheduling alone (usual care) on level of perceived personal control.
  • Pre-GCRA intervention effect on level of cancer genetics knowledge [ Time Frame: One week after genetic cancer risk assessment (GCRA) ] [ Designated as safety issue: No ]
    Evaluation of pre-GCRA intervention (culturally-informed motivational interview phone call) vs. control condition (health habit phone call) vs. scheduling alone (usual care) on level of cancer genetics knowledge.
Not Provided
Not Provided
 
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

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Healthy, no Evidence of Disease
  • Hereditary Breast/Ovarian Cancer - BRCA1
  • Hereditary Breast/Ovarian Cancer - BRCA2
  • 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 I
    Patients receive a culturally-informed adapted motivational interviewing telephone call.
    Interventions:
    • Other: questionnaire administration
    • Other: survey administration
    • Other: counseling intervention
    • Other: educational intervention
  • Experimental: Arm II
    Patients participate in a controlled condition comprising a health habits intervention group.
    Interventions:
    • Other: questionnaire administration
    • Other: survey administration
    • Other: counseling intervention
  • Active Comparator: Arm III
    Patients receive usual care comprising a standard scheduling phone call and proceed with normal GCRA process.
    Interventions:
    • Other: questionnaire administration
    • Other: survey administration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
404
Not Provided
September 2015   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Not Provided
United States
 
NCT01230346
08237, NCI-2010-01998
Yes
City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Jeffrey Weitzel City of Hope Medical Center
City of Hope Medical Center
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP