Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
With
Consenting patient participants will complete PRO surveys at baseline (T0) and 2 (T1), 4 (T2), 8 (T3) and 12 weeks (T4) after endocrine therapy initiation. Surveys will be administered within the Outcomes4Me smart phone app. Each survey will include 15 PRO-CTCAE items about common symptoms during adjuvant endocrine therapy. In addition, patient participants will self-report participants' endocrine therapy at each time point. Demographics and financial hardship will be assessed at baseline. Quality of life will be assessed at baseline and 12 weeks after endocrine therapy initiation. Global bother due to side effects of treatment will be assessed at each time point with the Functional Assessment of Cancer (FACT-B) General Population (GP5) item. Patient participants will also complete a single item from the Patient Reported Outcomes Measurement Information System (PROMIS) Medication Adherence Scale (PMAS) to assess overall adherence at 2, 4 and 8 weeks after endocrine therapy initiation and the entire PMAS 12 weeks after endocrine therapy initiation. In addition, patient participants will report participants' co-payment and pharmacy 2 weeks after endocrine therapy initiation and symptom management interventions the participants have pursued 12 weeks after endocrine therapy initiation. The clinical teams will be alerted if patient participants report severe or worsening symptoms exceeding pre-defined thresholds on the PRO-CTCAE questions. Both patients and members of the clinical team will be offered information about evidence-based symptom management strategies. Patients will complete an End-of-Study Evaluation 12 weeks after endocrine therapy initiation to provide feedback about the study intervention. Semi-structured interviews will be conducted with consenting members of the study teams and clinical teams at study sites with at least 2 patient participants, at least one of whom has passed the T2 survey time point and at least one of whom has had at least 1 alert for severe or worsening symptom(s). Semi-structured interviews will evaluate barriers and facilitators to implementation of the study intervention.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
