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Behavioural Intervention

Counseling for Hereditary Breast or Ovarian Cancer Risk

N/A

Waitlist Available

Led By Jeffrey Weitzel

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one week after genetic cancer risk assessment (gcra)

Awards & highlights

Study Summary

This trial looks at a new way to help Latinas at high risk for hereditary breast or ovarian cancer learn more about their risk.

Who is the study for?

This trial is for Latinas at high risk for hereditary breast or ovarian cancer who meet criteria for genetic testing. Participants must understand English or Spanish, be willing to consent, and can include pregnant women. It's aimed at those from low-income communities who are under- or uninsured.Check my eligibility

What is being tested?

The study tests a culturally-informed counseling intervention designed to educate high-risk Latina women about their cancer risks. It involves completing questionnaires and surveys, receiving educational materials, and participating in counseling sessions.See study design

What are the potential side effects?

Since this trial focuses on non-medical interventions like counseling and education rather than drugs or medical procedures, it does not have typical side effects associated with clinical trials that test medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You have a history of inherited breast or ovarian cancer.

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You meet the criteria for getting genetic testing for hereditary breast cancer according to the National Comprehensive Cancer Network (NCCN).

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Women who identify as being of Latino or Hispanic background.

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Women who do not have health insurance and are from low-income areas

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one week after genetic cancer risk assessment (gcra)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one week after genetic cancer risk assessment (gcra)

This trial's timeline: 3 weeks for screening, Varies for treatment, and one week after genetic cancer risk assessment (gcra) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Conduct a randomized controlled trial of a culturally-informed pre-GCRA telephone intervention utilizing AMI techniques

Anxiety

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

Secondary outcome measures

Perceived barriers to GCRA through no-show telephone interviews

Side effects data

From 2017 Phase 2 trial • 14 Patients • NCT01732445

86%

Platelet count decreased

64%

Anemia

36%

White blood cell decreased

29%

Neutrophil count decreased

21%

Nausea

21%

Diarrhea

14%

Edema limbs

14%

Alanine aminotransferase increased

14%

Pain in extremity

14%

Hyperkalemia

14%

Hyponatremia

Upper respiratory infection

Anorexia

Urinary tract infection

Irregular menstruation

Myocardial infarction

General disorders and administration site conditions - Other, specify

Sudden death NOS

Lung infection

Intracranial hemorrhage

Transient ischemic attacks

Premature menopause

Periorbital edema

Photosensitivity

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Supportive Care (Ruxolitinib Phosphate and Danazol)

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm IIExperimental Treatment3 Interventions

Patients participate in a controlled condition comprising a health habits intervention group.

Group II: Arm IExperimental Treatment4 Interventions

Patients receive a culturally-informed adapted motivational interviewing telephone call.

Group III: Arm IIIActive Control2 Interventions

Patients receive usual care comprising a standard scheduling phone call and proceed with normal GCRA process.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,920,967 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,660 Total Patients Enrolled

Jeffrey WeitzelPrincipal InvestigatorCity of Hope Medical Center

Media Library

Culturally-Informed Counseling (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT01230346 — N/A

BRCA1 Syndrome Research Study Groups: Arm II, Arm III, Arm I

BRCA1 Syndrome Clinical Trial 2023: Culturally-Informed Counseling Highlights & Side Effects. Trial Name: NCT01230346 — N/A

Culturally-Informed Counseling (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01230346 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings for new participants in this trial?

"Contrary to expectation, clinicaltrials.gov indicates that this medical trial has concluded recruitment of patients at the time being. It was initially posted on September 3rd 2010 and its last update occurred March 17th 2022; however, there are currently 5,947 other studies actively looking for candidates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2010. "Culturally-Informed Counseling in Latinas at High Risk for Hereditary Breast or Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01230346.

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