Questionnaire Administration
OtherAncillary studies
NCT Number: NCT01230346
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
Female
Interventional
Not applicable
City of Hope Medical Center, Duarte, California, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ancillary studies
Ancillary studies
Telephone intervention
Other names: counseling and communications studies
Telephone intervention
Other names: intervention, educational
Time frame: One week after genetic cancer risk assessment (GCRA)
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)
Time frame: One week after genetic cancer risk assessment (GCRA)
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)
City of Hope Medical Center
Other
Intervention to Promote Uptake of Cancer Risk Counseling for Underserved Latinas
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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