Culturally-Informed Counseling in Latinas at High Risk for Hereditary Breast or Ovarian Cancer
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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 |
- 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.
- 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 |
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| 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 | |
| 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 6, 2013 |
| 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 May 21, 2013