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NCT Number: NCT01230346

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center, Duarte, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire Administration

Other

Ancillary studies

Survey Administration

Other

Ancillary studies

counseling intervention

Other

Telephone intervention

Other names: counseling and communications studies

Educational Intervention

Other

Telephone intervention

Other names: intervention, educational

Primary outcomes

  1. 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)

    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.

  2. Experiences with the pre-GCRA intervention through post-intervention telephone interviews

    Time frame: One week after genetic cancer risk assessment (GCRA)

  3. 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)

    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 outcomes

  1. Perceived barriers to GCRA through no-show telephone interviews

    Time frame: One week after genetic cancer risk assessment (GCRA)

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Intervention to Promote Uptake of Cancer Risk Counseling for Underserved Latinas

Important dates

Study start
2010
Primary completion
2016
Study completion
2026
First posted
Oct 29, 2010
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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