Engaging M-health for Symptom Monitoring and Health Promotion for Women on Endocrine Therapy for Breast Cancer (EmSHAPE)

ConditionCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAbramson Cancer Center at Penn Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: ARM A InterventionExperimental treatment 1 intervention
Group B: ARM B Usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

System Usability Scale (SUS)

Determined via patient reported satisfaction with the intervention; final score from 0-100 (higher score represents better usability)

Time frame
Once during study exit survey at 6 months
2

Feasibility- recruitment rates and intervention completion rates

Evaluated via rates of recruitment and intervention completion

Time frame
Consent to study exit survey at 6 months

Secondary outcomes

1

Endocrine therapy adherence

Proportion of days participant takes medication

Time frame
Day 1 though study completion, an average of 48 weeks
2

FACTS-ES likert variables

Side effects of endocrine therapy

Time frame
Assessed at baseline (T0), 12 weeks (T1), and 24 weeks (T2)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abramson Cancer Center at Penn Medicine

Lead sponsor

Fox Chase Cancer Center

Collaborator

National Cancer Institute (NCI)

Collaborator