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Support Program for Breast Cancer

Phase 3
Recruiting
Research Sponsored by Alliance for Clinical Trials in Oncology
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 at 24 months post-randomization
Awards & highlights

Summary

This trial looks at how well patients stick to their medication plan when given text reminders and/or phone counseling.

Who is the study for?
This trial is for breast cancer patients who've had surgery or other treatments, except reconstruction. They must have hormone receptor positive, HER2-neu negative cancer and started endocrine therapy within the last 6 months or plan to start within 6 weeks after joining. Participants need a smartphone for study activities.
What is being tested?
The trial tests if text message reminders and telephone-based counseling can help breast cancer patients take their hormonal therapy medication as prescribed. It compares this additional support program with usual care to see if it improves medication adherence.
What are the potential side effects?
There are no direct medical side effects from participating in this trial since it involves non-medical interventions like text messaging and phone calls. However, participants may experience increased stress or anxiety from frequent communication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 24 months post-randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 24 months post-randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Endocrine therapy (ET) adherence at 12 months post-randomization
Secondary study objectives
Endocrine therapy (ET) adherence at 24 months post-randomization

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%
Hemorrhoids
2%
Acute kidney injury
2%
Hypothyroidism
2%
Blurred vision
2%
Urticaria
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%
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

4Treatment groups
Experimental Treatment
Active Control
Group I: Arm III (TMR + MI)Experimental Treatment5 Interventions
Patients receive online educational information about ET at the start of their ET medication. Patients also receive text messages as in Arm I and motivational interviewing counseling sessions as in Arm II.
Group II: Arm II (MI)Experimental Treatment4 Interventions
Patients receive online educational information about ET at the start of their ET medication. Patients also receive a total of 5 motivational interviewing counseling sessions via telephone over 30-90 minutes for up to 9 months. These sessions are designed to support patients while they take their ET medication, develop health goals, and stay on track in achieving those goals.
Group III: Arm I (TMR)Experimental Treatment4 Interventions
Patients receive online educational information about ET at the start of their ET medication. Patients also receive daily text message reminders to take their ET medication and monthly text messages about how they are doing with taking their ET medication. These text messages continue for 9 months.
Group IV: Arm IV (enhanced usual care)Active Control4 Interventions
Patients attend usual care clinic visits every 3-6 months and receive online educational information about ET at the start of their ET medication. Patients also receive optional online information about living a healthy life after breast cancer.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Motivational Interviewing
2020
Completed Phase 3
~8850

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,001,820 Total Patients Enrolled
945 Trials studying Breast Cancer
1,543,964 Patients Enrolled for Breast Cancer
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
216,292 Total Patients Enrolled
75 Trials studying Breast Cancer
40,143 Patients Enrolled for Breast Cancer
Katherine E. Reeder-Hayes, MDStudy ChairUniversity of North Carolina, Chapel Hill
~257 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
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