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Quality-of-Life Assessment for Breast Cancer
N/A
Waitlist Available
Led By Maysa Abu-Khaaf, MD
Research Sponsored by Thomas Jefferson University
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 up to one year
Awards & highlights
Study Summary
This trial looks at how well telehealth works in improving adherence to endocrine therapy for participants with hormone receptor positive breast cancer who have undergone surgery.
Who is the study for?
This trial is for men and women with stage 0-III hormone receptor positive breast cancer who've had surgery. Participants need a cell phone, must be able to text, have an ECOG status of 0-2, and agree to use telehealth tools like video chat. They should not have metastatic breast cancer or be unable to use digital communication tools.Check my eligibility
What is being tested?
The study tests if telehealth improves adherence to anti-estrogen therapy after surgery in breast cancer patients. It includes best practices, behavioral and educational interventions, questionnaires on quality-of-life, surveys, and uses smart pill bottles for medication tracking.See study design
What are the potential side effects?
While the trial focuses on adherence rather than drug effects, side effects may relate to endocrine therapy such as hot flashes, mood swings, fatigue or joint pain from the anti-estrogen medications being taken.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year post intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence to endocrine therapy (ET)
Secondary outcome measures
ET side effects
Quality of life assessment
Satisfaction with cancer care
Side effects data
From 2022 Phase 3 trial • 87 Patients • NCT0206618173%
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%
Blurred vision
2%
Hemorrhoids
2%
Hypothyroidism
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
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm III (Smart Pill Bottle, messaging)Experimental Treatment4 Interventions
Patients receive a wireless smart pill bottle that performs daily time-specific reminders to open the pill bottle and take the medication. Additional messages are triggered by the pill bottle when non-adherence is indicated (lack of bottle opening or no change in remaining pills), as well as when medication is skipped.
Group II: Arm II (Standard of Care Office Visits, survey, telehealth)Experimental Treatment5 Interventions
Patients receive standard of care as in Arm I and 4 automated electronic surveys every 3 weeks (+/- 1 weeks) for a total of 18 electronic surveys over one year. Patients who report severe or very severe side effects, or stopping or are thinking about stopping their ET will have a follow up encounter with a research coordinator.
Group III: Arm I (Standard of Care office Visits)Active Control3 Interventions
Participants receive standard of care office visits approximately every 3 months (± 2 weeks) for one year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Intervention
2021
Completed Phase 4
~3740
Find a Location
Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
445 Previous Clinical Trials
145,409 Total Patients Enrolled
5 Trials studying Breast Cancer
607 Patients Enrolled for Breast Cancer
Maysa Abu-Khaaf, MDPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to get out of my bed or chair and move around.My breast cancer stage was determined using the latest guidelines.I have stage IV metastatic breast cancer.I have had breast surgery for my breast cancer.I am willing to create an online Jefferson MyChart account.I have been on hormone therapy for over 4 years.My breast cancer is in stages 0-III and is hormone receptor positive.My doctor has prescribed hormone therapy after my main treatment.I am getting radiation and hormone therapy after surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (Standard of Care Office Visits, survey, telehealth)
- Group 2: Arm III (Smart Pill Bottle, messaging)
- Group 3: Arm I (Standard of Care office Visits)
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.
How many venues are implementing this scientific investigation?
"Five distinct healthcare centres are currently enrolling patients in this clinical trial. These include Jefferson Health - South Jersey, Jefferson Health - Northeast, and Thomas Jefefrson University situated within Washington Township, Torresdale and Willow Grove respectively; plus two additional sites."
Answered by AI
Is enrollment available to individuals interested in participating in this trial?
"According to the information presented on clinicaltrials.gov, this medical trial is presently searching for participants. The study was initially published on July 31st 2019 and its details were last revised Oct 18th 2022."
Answered by AI
Has the Quality-of-Life Assessment earned FDA authorization?
"Our team at Power assigned Quality-of-Life Assessment a score of 2 due to the lack of efficacy data in Phase 2 clinical trials, although there is evidence that suggests it is safe."
Answered by AI
How many people have enrolled in this trial thus far?
"Affirmative. According to clinicaltrials.gov, the trial is open for enrolment and was initially posted on July 31st 2019 with a recent update on October 18th 2022. A total of 285 patients will be accepted across 5 different healthcare settings."
Answered by AI
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