Culturally-Informed Counseling in Latinas at High Risk for Hereditary Breast or Ovarian Cancer
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| First Received Date ICMJE | September 22, 2010 | ||||
| Last Updated Date | March 6, 2013 | ||||
| Start Date ICMJE | September 2010 | ||||
| Estimated Primary Completion Date | September 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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. |
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| Change History | Complete list of historical versions of study NCT01230346 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Perceived barriers to GCRA through no-show telephone interviews [ Time Frame: One week after genetic cancer risk assessment (GCRA) ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Culturally-Informed Counseling in Latinas at High Risk for Hereditary Breast or Ovarian Cancer | ||||
| Official Title ICMJE | Intervention to Promote Uptake of Cancer Risk Counseling for Underserved Latinas | ||||
| Brief Summary | A culturally-informed intervention may be an effective method to help people learn more about their cancer risk. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Intervention ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 404 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | September 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01230346 | ||||
| Other Study ID Numbers ICMJE | 08237, NCI-2010-01998 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | City of Hope Medical Center | ||||
| Study Sponsor ICMJE | City of Hope Medical Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | City of Hope Medical Center | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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