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Engaging M-health for Symptom Monitoring and Health Promotion for Women on Endocrine Therapy for Breast Cancer (EmSHAPE)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at ways to help women understand, track, and manage side effects from breast cancer hormone therapy. It is for women with Stage 0–III breast cancer who recently started hormone therapy pills. What researchers learn will help them plan future studies of tools to help patients manage symptoms and stay on treatment.

The purpose of the study is to learn more about ways to help patients understand and manage side-effects from hormone therapy. The investigators will use the information from this study to design future studies to better understand how our well our tools work to help patients monitor and manage symptoms from hormone therapy and to stay on their hormone therapy for the recommended period of time.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Identify as a woman and be age 18 or older.
  • Have Stage 0, I, II, or III hormone receptor-positive (HR+) breast cancer, which uses hormones to grow.
  • Have started your first hormone therapy pills within 16 weeks before signing up: tamoxifen, anastrozole, exemestane, or letrozole.
  • Have finished breast cancer surgery at least 14 days before being assigned to a study group.
  • If you had chemotherapy, have finished it at least 14 days before being assigned to a study group.
  • Speak and read English.
  • Own a cell phone with internet access and be able to use the study's electronic pill bottle.
  • You may receive radiation or ongoing targeted or biologic treatment during the study.

Who can't join

  • Have Stage IV breast cancer, which has spread to distant parts of the body.
  • Identify as male.
  • Have had hormone therapy for breast cancer before your current treatment.
  • Have hearing, vision, or speech problems that are not corrected or managed and make communication difficult.
  • Have an uncontrolled mental health condition or severe physical, nerve, brain, or thinking problems that prevent you from understanding the study's goals and tasks.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Participants must identify as a woman * Participants must be age 18 or older * Participants must have a diagnosis of Stage 0, I, II, or III HR+ breast cancer * Participants must have started initial treatment with standard of care oral endocrine therapy (ET) (i.e., tamoxifen, anastrozole, exemestane, or letrozole) within 16 weeks of study registration. * Participants must have completed surgery for treatment of breast cancer at least 14 days prior to randomization. * Participants who received chemotherapy must have finished it at least 14 days prior to randomization. * Speak and read in English * Own an internet-enabled cell phone * Capable of using the electronic pill bottle * Concomitant radiotherapy is allowed. Concomitant maintenance targeted or biologic therapy (e.g., anti-HER2 therapy, osteoclast inhibitor therapy, CDK 4/6 inhibitor, ovarian function suppression medications) is allowed. Exclusion Criteria: * Metastatic (Stage IV) breast cancer * Male gender * Prior treatment with endocrine therapy for breast cancer * Communication difficulties such as: Uncorrected or uncompensated hearing and/or vision impairment, uncorrected or uncompensated speech defects, uncontrolled psychiatric/mental condition or severe physical, neurological or cognitive deficits rendering individual unable to understand study goals and tasks

Study sites (1)

PA