Engaging M-health for Symptom Monitoring and Health Promotion for Women on Endocrine Therapy for Breast Cancer (EmSHAPE)
Recruiting · NCT07454499 · Interventional (participants receive a specific treatment) · Lead sponsor: Abramson Cancer Center at Penn Medicine
View the official record on ClinicalTrials.gov →Interventions studied
Digital Endocrine therapy Symptom Monitoring and Education Intervention
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Abramson Cancer Center at the University of Pennsylvania - Philadelphia, Pennsylvania, United States