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Behavioural Intervention

Counseling for Hereditary Breast or Ovarian Cancer Risk

N/A
Waitlist Available
Led By Bita Nehoray
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one week after genetic cancer risk assessment (gcra)
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Conduct a randomized controlled trial of a culturally-informed pre-GCRA telephone intervention utilizing AMI techniques
Anxiety

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%
Diarrhea
21%
Nausea
14%
Edema limbs
14%
Alanine aminotransferase increased
14%
Pain in extremity
14%
Hyperkalemia
14%
Hyponatremia
7%
Anorexia
7%
Hypertension
7%
Upper respiratory infection
7%
Urinary tract infection
7%
Irregular menstruation
7%
Myocardial infarction
7%
General disorders and administration site conditions - Other, specify
7%
Sudden death NOS
7%
Lung infection
7%
Intracranial hemorrhage
7%
Transient ischemic attacks
7%
Premature menopause
7%
Periorbital edema
7%
Photosensitivity
100%
80%
60%
40%
20%
0%
Study treatment Arm
Supportive Care (Ruxolitinib Phosphate and Danazol)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,922,954 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,022,677 Total Patients Enrolled
Bita NehorayPrincipal InvestigatorCity of Hope Medical Center
Jeffrey WeitzelPrincipal InvestigatorCity of Hope Medical Center

Media Library

Culturally-Informed Counseling (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT01230346 — N/A
Breast cancer Research Study Groups: Arm II, Arm III, Arm I
Breast cancer 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
~32 spots leftby Dec 2025
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