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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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have metastatic cancer or a second primary cancer.
Select...
I am 18 or older and identify as African-American.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ability of peer navigation to improve understanding of SCP
Adherence to the SCP schedule of follow-up examinations
Secondary outcome measures
Effect of PN on change in medical efficacy
Physical and health related QOL
Preparedness for life as new survivor (PLANS)
Side effects data
From 2008 Phase 3 trial • 186 Patients • NCT0000386961%
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%
Cough
8%
Arthralgia
7%
Vision-Blurred
6%
Depression
6%
Pain
4%
Headache
4%
Diarrhea-No Colostom
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%
Hemoptysis
2%
Muscle Weakness
2%
Dyspepsia
2%
Hyponatremia
2%
SGPT (ALT) (serum glutamic pyruvic transaminase)
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%
Epistaxis
1%
Dysphagia
1%
Fever-No ANC
1%
Hypotension
1%
Hypertension
1%
Insomnia
1%
Mouth Dryness
1%
Pulmonary
1%
Pruritis
1%
Flatulence
1%
Stomatitis
1%
Hypoalbuminemia
1%
Vision
1%
Hypoxia
1%
Smell
1%
Arrythmia
1%
Sweating
1%
Voice Change
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
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
13,654 Previous Clinical Trials
40,933,008 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,215 Patients Enrolled for Breast Cancer
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,315 Total Patients Enrolled
42 Trials studying Breast Cancer
6,504 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you have a serious medical or mental health condition, such as anxiety, depression, or problems with alcohol or tobacco, you will not be able to participate.I finished my breast cancer treatment 1-12 months ago.I have metastatic cancer or a second primary cancer.I am 18 or older and identify as African-American.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (PN and ACS material)
- Group 2: Arm II (ACS material)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies for this research trial?
"Data hosted on clinicaltrials.gov reveals that this medical experiment is no longer enrolling patients. Initially posted on June 1st 2012, the study was last updated on July 8th 2022 and has since concluded recruitment efforts; however, 2,602 other trials are still recruiting participants at present."
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