Engaging M-health for Symptom Monitoring and Health Promotion for Women on Endocrine Therapy for Breast Cancer (EmSHAPE)
Purpose
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.
Condition
- Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ARM A Intervention |
Patients assigned to symptom monitoring web-based intervention. |
|
|
No Intervention ARM B Usual care |
Participants will be provided with an educational handout describing endocrine therapy. |
|
Recruiting Locations
Philadelphia, Pennsylvania 19104
More Details
- Status
- Recruiting
- Sponsor
- Abramson Cancer Center at Penn Medicine
Detailed Description
Despite robust available data supporting the efficacy of oral endocrine therapy (ET) for the treatment of breast cancer and the low adherence to this life-saving treatment, only 6 randomized controlled trials have assessed interventions to improve adherence to ET; only 1 showed modest short-term benefit. ET adherence is critical, as 10-year survival decreases from 81% when adherent to 74% when non-adherent to ET. The investigators propose a first of its kind, randomized, culturally tailored mHealth intervention trial called "EmSHAPE"- Engaging mobile health for symptom monitoring and health promotion for endocrine therapy - among newly diagnosed women with early hormone receptor positive breast cancer. Prior intervention studies have not been effective.