What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly endocrine therapies like tamoxifen and aromatase inhibitors, have several known side effects. Tamoxifen can cause hot flashes, vaginal dryness or discharge, and an increased risk of blood clots and endometrial cancer. Aromatase inhibitors, such as anastrozole, can lead to bone density loss, joint pain, and an increased risk of fractures. Chemotherapy often results in hair loss, nausea, fatigue, and a higher risk of infections due to lowered white blood cell counts. Radiation therapy can cause skin irritation, fatigue, and in some cases, long-term changes in the breast tissue. These side effects should be discussed with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several endocrine therapies for the treatment of hormone receptor-positive breast cancer. These include selective estrogen receptor modulators (SERMs) like tamoxifen, aromatase inhibitors such as anastrozole, letrozole, and exemestane, and selective estrogen receptor degraders (SERDs) like fulvestrant. These therapies are designed to block the effects of estrogen on breast cancer cells, which is crucial for patients with estrogen receptor-positive tumors. The use of digital communication tools, as studied in the Telehealth trial, aims to improve adherence to these therapies, ensuring patients receive the full benefit of their prescribed treatment regimens.

What other types of research exist?

Promising alternatives to telehealth for improving adherence to endocrine therapy in breast cancer patients include mobile health applications, smart pill bottles, and digital self-management platforms. Mobile apps can provide reminders, educational content, and motivational support. Smart pill bottles track medication usage and send alerts to patients and caregivers. Digital self-management platforms offer comprehensive tools for monitoring symptoms, managing side effects, and maintaining communication with healthcare providers.

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Telehealth 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

No Placebo-Only Group

Summary

This trial uses video chats, online surveys, and special pill bottles to help breast cancer patients stick to their medication. It targets patients who have had surgery for hormone receptor-positive breast cancer. The tools remind patients to take their medication and provide easy ways to report side effects and get help. Tamoxifen, aromatase inhibitors, and fulvestrant have been used for decades in the therapy of hormone-receptor-positive breast cancer patients.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence to endocrine therapy (ET)

Secondary study objectives

ET side effects

Quality of life assessment

Satisfaction with cancer care

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

Back pain

Headache

Nervous system disorders - Other, specify

Pain in extremity

General disorders and administration site conditions - Other, specify

Skin infection

White blood cell decreased

Hypercalcemia

Hypokalemia

Musculoskeletal and connective tissue disorder - Other, specify

Dizziness

Respiratory, thoracic and mediastinal disorders - Other, specify

Eye disorders - Other, specify

Hyperkalemia

Pain

Alkaline phosphatase increased

Hypocalcemia

Cough

Flushing

Tinnitus

Dental caries

Gastrointestinal disorders - Other, specify

Hemoglobin increased

Weight loss

Metabolism and nutrition disorders - Other, specify

Dysgeusia

Anxiety

Irregular menstruation

Menorrhagia

Sore throat

Lymphocyte count decreased

Hyperuricemia

Non-cardiac chest pain

Infections and infestations - Other, specify

Hypernatremia

Hypoglycemia

Scalp pain

Dry mouth

Blurred vision

Hypothyroidism

Urticaria

Hemorrhoids

Acute kidney injury

Palpitations

Leukocytosis

Myocardial infarction

Vertigo

Anal hemorrhage

Dysphagia

Esophageal pain

Periodontal disease

Fever

Sinusitis

Urinary tract infection

Bruising

Dermatitis radiation

Cholesterol high

Creatinine increased

Neck pain

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Concentration impairment

Memory impairment

Spasticity

Depression

Insomnia

Allergic rhinitis

Productive cough

Sleep apnea

Pregnancy, puerperium and perinatal conditions - Other, specify

Dry eye

Lymphedema

Chest pain - cardiac

Heart failure

Gastric perforation

Hypertriglyceridemia

Dyspnea

Cardiac disorders - Other, specify

Gastroesophageal reflux disease

Oral dysesthesia

Chills

Hypophosphatemia

Chest wall pain

Psychiatric disorders - Other, specify

Hematuria

Urinary tract obstruction

Dysmenorrhea

Skin hypopigmentation

Unintended pregnancy

Flu like symptoms

Nail infection

Pancreatitis

Blood and lymphatic system disorders - Other, specify

Oral pain

Fall

100%

80%

60%

40%

20%

Study treatment Arm

Arm I (Sorafenib Tosylate)

Arm II (Placebo)

Crossover Group

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for breast cancer, particularly hormone receptor-positive types, include endocrine therapies such as selective estrogen receptor modulators (SERMs), aromatase inhibitors, and estrogen receptor downregulators (ERDs). SERMs, like tamoxifen, block estrogen receptors on breast cancer cells, preventing estrogen from binding and promoting cancer cell growth. Aromatase inhibitors, such as anastrozole, reduce the production of estrogen by inhibiting the enzyme aromatase, which converts androgens to estrogen in postmenopausal women. ERDs, like fulvestrant, degrade estrogen receptors, reducing the number of receptors available for estrogen binding. These treatments are crucial as they target the hormonal pathways that fuel the growth of hormone receptor-positive breast cancer, thereby slowing disease progression and improving survival rates. The use of digital communication tools in Telehealth can enhance adherence to these therapies by providing continuous support and monitoring, ensuring patients receive the full benefit of their treatment regimen.

Endocrine and targeted manipulation of breast cancer: summary statement for the Sixth Cambridge Conference.