Culturally-Informed Counseling in Latinas at High Risk for Hereditary Breast or Ovarian Cancer
Primary Purpose
No Evidence of Disease, BRCA1 Syndrome, BRCA2 Syndrome
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
questionnaire administration
survey administration
counseling intervention
educational intervention
Sponsored by
About this trial
This is an interventional supportive care trial for No Evidence of Disease
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
Sites / Locations
- City of Hope Medical Center
- University of Southern California-Keck School of Medicine
- Olive View-UCLA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Arm I
Arm II
Arm III
Arm Description
Patients receive a culturally-informed adapted motivational interviewing telephone call.
Patients participate in a controlled condition comprising a health habits intervention group.
Patients receive usual care comprising a standard scheduling phone call and proceed with normal GCRA process.
Outcomes
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
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
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.
Secondary Outcome Measures
Perceived barriers to GCRA through no-show telephone interviews
Full Information
NCT ID
NCT01230346
First Posted
September 22, 2010
Last Updated
June 14, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01230346
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 3, 2010 (Actual)
Primary Completion Date
November 10, 2016 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
No Evidence of Disease, BRCA1 Syndrome, BRCA2 Syndrome, Hereditary Female Breast Carcinoma, Hereditary Ovarian Carcinoma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
493 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive a culturally-informed adapted motivational interviewing telephone call.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients participate in a controlled condition comprising a health habits intervention group.
Arm Title
Arm III
Arm Type
Active Comparator
Arm Description
Patients receive usual care comprising a standard scheduling phone call and proceed with normal GCRA process.
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
survey administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
counseling intervention
Other Intervention Name(s)
counseling and communications studies
Intervention Description
Telephone intervention
Intervention Type
Other
Intervention Name(s)
educational intervention
Other Intervention Name(s)
intervention, educational
Intervention Description
Telephone intervention
Primary Outcome Measure Information:
Title
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
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.
Time Frame
One week after genetic cancer risk assessment (GCRA)
Title
Experiences with the pre-GCRA intervention through post-intervention telephone interviews
Time Frame
One week after genetic cancer risk assessment (GCRA)
Title
Conduct a randomized controlled trial of a culturally-informed pre-GCRA telephone intervention utilizing AMI techniques
Description
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.
Time Frame
One week after genetic cancer risk assessment (GCRA)
Secondary Outcome Measure Information:
Title
Perceived barriers to GCRA through no-show telephone interviews
Time Frame
One week after genetic cancer risk assessment (GCRA)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bita Nehoray
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of Southern California-Keck School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Olive View-UCLA Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Culturally-Informed Counseling in Latinas at High Risk for Hereditary Breast or Ovarian Cancer
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