Clinical trial · Interventional
Engaging M-health for Symptom Monitoring and Health Promotion for Women on Endocrine Therapy for Breast Cancer (EmSHAPE)
NCT07454499CI-TRIAL-00114535recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Digital Endocrine therapy Symptom Monitoring and Education Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ARM A Intervention
- description
- Patients assigned to symptom monitoring web-based intervention.
- interventionNames
- Behavioral: Digital Endocrine therapy Symptom Monitoring and Education Intervention
- type
- NO_INTERVENTION
- label
- ARM B Usual care
- description
- Participants will be provided with an educational handout describing endocrine therapy.
Primary outcomes (2)
- measure
- System Usability Scale (SUS)
- timeFrame
- Once during study exit survey at 6 months
- description
- Determined via patient reported satisfaction with the intervention; final score from 0-100 (higher score represents better usability)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.