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Peer Navigator Education for Breast Cancer Survivorship

N/A
Waitlist Available
Led By Kimlin Ashing-Giwa
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
Patients with metastatic cancer or a second primary cancer, because their medical characteristics (e.g. disease progression) are significantly different
Patient age 18 years or older who self-identifies as African-American
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at whether an educational intervention involving peer groups can help improve the well-being and quality of life for African American breast cancer survivors.

Who is the study for?
This trial is for African American breast cancer survivors who are 1-12 months post-treatment for stage 0-3 cancer, over 18 years old, and receive care through an HMO. It's not for those with metastatic or a second primary cancer, nor for individuals with major medical conditions like severe anxiety, depression, or substance abuse issues.
What is being tested?
The study tests if peer navigator education can improve the quality of life in these survivors. Participants will be randomly placed into groups where they'll receive educational sessions and counseling from peers to help manage their survivorship care.
What are the potential side effects?
Since this trial focuses on education and counseling interventions rather than medication, traditional side effects are not expected. However, participants may experience emotional distress or discomfort when discussing their experiences.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have metastatic cancer or a second primary cancer.
Select...
I am 18 or older and identify as African-American.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ability of peer navigation to improve understanding of SCP
Adherence to the SCP schedule of follow-up examinations
Secondary study objectives
Effect of PN on change in medical efficacy
Preparedness for life as new survivor (PLANS)

Side effects data

From 2008 Phase 3 trial • 186 Patients • NCT00003869
61%
Nausea
59%
Neuro-Sensory
53%
Fatigue
49%
Anemia
32%
Vomiting
32%
Ataxia
31%
Anorexia
17%
Dyspnea
16%
Constipation
13%
Alopecia
12%
Thrombocytopenia
9%
Neutropenia
9%
Creatinine
9%
Dizziness
8%
Arthralgia
8%
Cough
7%
Vision-Blurred
6%
Depression
6%
Pain
4%
Diarrhea-No Colostom
4%
Headache
4%
Edema
4%
Infection without neutropenia
4%
Hyperglycemia
4%
Neuro-Motor
3%
Rash
3%
SGOT (AST) (serum glutamic oxaloacetic transaminase)
3%
Pain-Abdominal
3%
Pain-Chest
3%
Lymphopenia
3%
Myalgia
3%
Taste
3%
Weight loss
2%
Dyspepsia
2%
Hyponatremia
2%
Hemoptysis
2%
SGPT (ALT) (serum glutamic pyruvic transaminase)
2%
Muscle Weakness
2%
Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)
2%
Bilirubin
2%
Leukopenia
2%
Pain-Bone
2%
Low Consciousness
2%
Memory Loss
2%
Neuralgia
2%
Inner Ear
2%
Anxiety
2%
Confusion
1%
Pruritis
1%
Hypoxia
1%
Stomatitis
1%
Dysphagia
1%
Hypoalbuminemia
1%
Insomnia
1%
Voice Change
1%
Vision
1%
Hypotension
1%
Mouth Dryness
1%
Smell
1%
Hypertension
1%
Arrythmia
1%
Sweating
1%
Epistaxis
1%
Flatulence
1%
Fever-No ANC
1%
Pulmonary
1%
Hematemesis
1%
Prothrombin Time
1%
Adult respiratory distress syndrome (ARDS)
1%
Effusion-Pleural
1%
Pneumonitis
1%
Arrhythmia-Nodal
1%
Cardiovascular
1%
Palpitations
1%
Vision-Double
1%
Rigors
1%
Hypokalemia
1%
Musculoskeletal
1%
Learning Disorder
1%
Tremor
1%
Diarrhea-BMT
1%
Allergy
1%
Dehydration
1%
Thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Carboxyamidotriazole

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (PN and ACS material)Experimental Treatment5 Interventions
Participants receive 4 PN sessions tailored to their needs followed by a 6 month booster session and ACS materials.
Group II: Arm II (ACS material)Active Control4 Interventions
Participants receive ACS materials only.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
quality-of-life assessment
2012
Completed Phase 3
~2780

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,920 Previous Clinical Trials
41,016,789 Total Patients Enrolled
941 Trials studying Breast Cancer
1,443,092 Patients Enrolled for Breast Cancer
City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,435 Total Patients Enrolled
41 Trials studying Breast Cancer
4,732 Patients Enrolled for Breast Cancer
Kimlin Ashing-GiwaPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
150 Total Patients Enrolled
1 Trials studying Breast Cancer
100 Patients Enrolled for Breast Cancer

Media Library

Peer Navigator Education Clinical Trial Eligibility Overview. Trial Name: NCT01450020 — N/A
Breast Cancer Research Study Groups: Arm I (PN and ACS material), Arm II (ACS material)
Breast Cancer Clinical Trial 2023: Peer Navigator Education Highlights & Side Effects. Trial Name: NCT01450020 — N/A
Peer Navigator Education 2023 Treatment Timeline for Medical Study. Trial Name: NCT01450020 — N/A
~0 spots leftby Dec 2024
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