Cancer
Conditions
Brief summary
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.
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.
Interventions
BEHAVIORALDigital Endocrine therapy Symptom Monitoring and Education Intervention
Patients will receive text messages with links to symptom monitoring surveys and educational materials on possible symptoms from endocrine therapy.
Sponsors
Abramson Cancer Center at Penn Medicine
Fox Chase Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| System Usability Scale (SUS) | Once during study exit survey at 6 months | Determined via patient reported satisfaction with the intervention; final score from 0-100 (higher score represents better usability) |
| Feasibility- recruitment rates and intervention completion rates | Consent to study exit survey at 6 months | Evaluated via rates of recruitment and intervention completion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endocrine therapy adherence | Day 1 though study completion, an average of 48 weeks | Proportion of days participant takes medication |
| FACTS-ES likert variables | Assessed at baseline (T0), 12 weeks (T1), and 24 weeks (T2) | Side effects of endocrine therapy |
Countries
United States
Contacts
CONTACTKimberley Lee
CONTACTKelsey Karpink
PRINCIPAL_INVESTIGATORKimberley Lee, MD
University of Pennsylvania
Outcome results
None listed