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| ID | Type | Description | Link |
|---|---|---|---|
| IRB# 856525 | Other Identifier | Penn IRB | |
| K08CA279076 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Fox Chase Cancer Center | OTHER |
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM A Intervention | Experimental | Patients assigned to symptom monitoring web-based intervention. |
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| ARM B Usual care | No Intervention | Participants will be provided with an educational handout describing endocrine therapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Endocrine therapy Symptom Monitoring and Education Intervention | Behavioral | Patients will receive text messages with links to symptom monitoring surveys and educational materials on possible symptoms from endocrine therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| System Usability Scale (SUS) | Determined via patient reported satisfaction with the intervention; final score from 0-100 (higher score represents better usability) | Once during study exit survey at 6 months |
| Feasibility- recruitment rates and intervention completion rates | Evaluated via rates of recruitment and intervention completion | Consent to study exit survey at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Endocrine therapy adherence | Proportion of days participant takes medication | Day 1 though study completion, an average of 48 weeks |
| FACTS-ES likert variables | Side effects of endocrine therapy |
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Inclusion Criteria:
Exclusion Criteria:
Participants must identify as a woman.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kimberley Lee | Contact | 215-615-1736 | kimberley.lee@pennmedicine.upenn.edu | |
| Kelsey Karpink | Contact | 215-662-3531 | kelsey.karpink@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kimberley Lee, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center at the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Assessed at baseline (T0), 12 weeks (T1), and 24 weeks (T2) |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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