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Quality of Life Intervention for Young African American Women with Breast Cancer

N/A
Recruiting
Led By Timiya Nolan, PhD
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18 to 44 years on study entry
In treatment with chemotherapy and/or radiation for stage I-III breast cancer at study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial will study whether the Y-AMBIENT intervention can help young African American breast cancer survivors manage daily life and improve their quality of life.

Who is the study for?
This trial is for African American women, aged 18-44, who are currently undergoing treatment for stage I-III breast cancer. Participants must speak English and have access to a telephone and the internet. Women already in survivorship programs cannot join as it may affect the study's results.Check my eligibility
What is being tested?
The Y-AMBIENT program is being tested to see if it can improve life quality for young African American breast cancer survivors. It's a four-month phone-based intervention with education sessions, follow-ups, written materials, and videos.See study design
What are the potential side effects?
Since this trial focuses on educational interventions and quality-of-life assessments rather than medical treatments or drugs, there are no direct side effects associated with typical clinical trials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 44 years old.
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I am currently receiving treatment for stage I-III breast cancer.
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I was assigned female at birth.
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My breast cancer is at an early to mid-stage (I-III).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
(Functional Assessment of Chronic Illness Therapy Spiritual Well-Being (FACT-Sp 12)
Acceptability/Relevance of Intervention Sessions
COmprehensive Score for Financial Toxicity [COST]-Functional Assessment of Chronic Illness Therapy [FACIT]
+9 more

Side effects data

From 2022 Phase 3 trial • 87 Patients • NCT02066181
73%
Fatigue
71%
Palmar-plantar erythrodysesthesia syndrome
63%
Hypertension
61%
Papulopustular rash
55%
Diarrhea
51%
Nausea
39%
Myalgia
37%
Alopecia
35%
Arthralgia
33%
Abdominal pain
31%
Anorexia
27%
Vomiting
22%
Mucositis oral
22%
Constipation
18%
Anemia
18%
Alanine aminotransferase increased
16%
Platelet count decreased
14%
Pruritus
14%
Hyperglycemia
14%
Rash maculo-papular
14%
Skin and subcutaneous tissue disorders - Other, specify
12%
Aspartate aminotransferase increased
12%
Rash acneiform
12%
Peripheral sensory neuropathy
10%
Investigations - Other, specify
10%
Dry skin
10%
Neutrophil count decreased
10%
Blood bilirubin increased
8%
Back pain
8%
Headache
8%
Nervous system disorders - Other, specify
8%
Pain in extremity
6%
General disorders and administration site conditions - Other, specify
6%
Skin infection
6%
White blood cell decreased
6%
Hypercalcemia
6%
Hypokalemia
6%
Musculoskeletal and connective tissue disorder - Other, specify
6%
Dizziness
6%
Respiratory, thoracic and mediastinal disorders - Other, specify
6%
Eye disorders - Other, specify
6%
Hyperkalemia
6%
Pain
6%
Alkaline phosphatase increased
6%
Hypocalcemia
6%
Cough
4%
Flushing
4%
Tinnitus
4%
Dental caries
4%
Gastrointestinal disorders - Other, specify
4%
Hemoglobin increased
4%
Weight loss
4%
Metabolism and nutrition disorders - Other, specify
4%
Dysgeusia
4%
Anxiety
4%
Irregular menstruation
4%
Menorrhagia
4%
Sore throat
4%
Lymphocyte count decreased
4%
Hyperuricemia
4%
Non-cardiac chest pain
4%
Infections and infestations - Other, specify
4%
Hypernatremia
4%
Hypoglycemia
4%
Scalp pain
4%
Dry mouth
2%
Acute kidney injury
2%
Hypothyroidism
2%
Hemorrhoids
2%
Blurred vision
2%
Palpitations
2%
Leukocytosis
2%
Myocardial infarction
2%
Vertigo
2%
Anal hemorrhage
2%
Dysphagia
2%
Esophageal pain
2%
Periodontal disease
2%
Fever
2%
Sinusitis
2%
Urinary tract infection
2%
Bruising
2%
Dermatitis radiation
2%
Cholesterol high
2%
Creatinine increased
2%
Neck pain
2%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
2%
Concentration impairment
2%
Memory impairment
2%
Spasticity
2%
Depression
2%
Insomnia
2%
Allergic rhinitis
2%
Productive cough
2%
Sleep apnea
2%
Pregnancy, puerperium and perinatal conditions - Other, specify
2%
Dry eye
2%
Lymphedema
2%
Chest pain - cardiac
2%
Heart failure
2%
Gastric perforation
2%
Hypertriglyceridemia
2%
Dyspnea
2%
Cardiac disorders - Other, specify
2%
Gastroesophageal reflux disease
2%
Oral dysesthesia
2%
Chills
2%
Hypophosphatemia
2%
Chest wall pain
2%
Psychiatric disorders - Other, specify
2%
Hematuria
2%
Urinary tract obstruction
2%
Dysmenorrhea
2%
Skin hypopigmentation
2%
Urticaria
2%
Unintended pregnancy
2%
Flu like symptoms
2%
Nail infection
2%
Pancreatitis
2%
Blood and lymphatic system disorders - Other, specify
2%
Oral pain
2%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Sorafenib Tosylate)
Arm II (Placebo)
Crossover Group

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (Y-AMBIENT)Experimental Treatment3 Interventions
Patients receive three themed education sessions over 1 hour each, written materials, and videos at month 1. Patients also participate in 3, 20 minutes telephone reinforcement calls to discuss how they are doing and discuss any concerns that they are still managing at months 2, 3, and 4.
Group II: Arm II (enhanced usual care)Active Control3 Interventions
Patients receive usual care at month 1. Patients also participate in 3, 20 minutes telephone reinforcement calls to discuss their chemotherapy regimen at months 2, 3, and 4.

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
320 Previous Clinical Trials
290,176 Total Patients Enrolled
22 Trials studying Breast Cancer
2,884 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,355 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,343 Patients Enrolled for Breast Cancer
Timiya Nolan, PhDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Breast Cancer
30 Patients Enrolled for Breast Cancer

Media Library

Y-AMBIENT Clinical Trial Eligibility Overview. Trial Name: NCT05243056 — N/A
Breast Cancer Research Study Groups: Arm II (enhanced usual care), Arm I (Y-AMBIENT)
Breast Cancer Clinical Trial 2023: Y-AMBIENT Highlights & Side Effects. Trial Name: NCT05243056 — N/A
Y-AMBIENT 2023 Treatment Timeline for Medical Study. Trial Name: NCT05243056 — N/A

Frequently Asked Questions

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

Would participants of this clinical investigation need to be younger than 25 years old?

"This clinical trial is limited to individuals aged 18-44. Meanwhile, there are 64 studies for applicants under the age of eighteen and 2209 research projects involving seniors that exceed 65 years old."

Answered by AI

Are there any openings for people to join this clinical experiment?

"Clinicaltrials.gov indicates that this medical trial, which was uploaded on June 1st 2022 and revised on July 6th 2022, is actively recruiting participants."

Answered by AI

Who is the optimum participant for this trial enrollment?

"This medical research is searching for 40 female volunteers between 18 and 44 years old who have been clinically diagnosed with breast cancer at stages I-III. The ideal candidate should meet the following criteria: biologically born women, self-identify as African American (AA), be English speaking, possess telephone and internet access."

Answered by AI

What is the total participant count for this experiment?

"Affirmative. Research on clinicaltrials.gov demonstrates that this investigation is actively seeking volunteers, first posted June 1st 2022 and recently updated July 6th 2022. 40 individuals must be enlisted from a single site for the trial to proceed."

Answered by AI
~15 spots leftby Mar 2025