TY  - JOUR
AU  - Lund-Jacobsen, Trine
AU  - Schwarz, Peter
AU  - Martino, Gabriella
AU  - Pappot, Helle
AU  - Piil, Karin
PY  - 2024
DA  - 2024/2/15
TI  - Development of an App for Symptom Management in Women With Breast Cancer Receiving Maintenance Aromatase Inhibitors: Protocol for a Mixed Methods Feasibility Study
JO  - JMIR Res Protoc
SP  - e49549
VL  - 13
KW  - acceptability
KW  - aromatase inhibitors
KW  - breast cancer
KW  - cancer
KW  - chemotherapy
KW  - disease
KW  - feasibility
KW  - inhibitor
KW  - management
KW  - mHealth
KW  - postmenopausal
KW  - psychosocial
KW  - QoL
KW  - quality of life
KW  - radiation therapy
KW  - symptom management
KW  - symptom
KW  - tool
KW  - treatment
KW  - usability
KW  - user-friendliness
AB  - Background: Patients with postmenopausal nonmetastatic estrogen receptor–positive breast cancer often experience a reduced quality of life after primary treatment. The disease and treatment trajectory consists of surgery followed by chemotherapy or radiation therapy. Upon this, maintenance hormone therapy with an aromatase inhibitor can result in several physical and psychosocial symptoms. Optimal symptom control during maintenance therapy is central to maintaining the patient’s quality of life. Objective: This study aims to (1) develop an electronic symptom management tool for patients with postmenopausal early breast cancer receiving maintenance aromatase inhibitors with an endocrine aspect and (2) assess the feasibility, acceptability, and usability of the pilot version of the Bone@BC app. Furthermore, longitudinally, symptom prevalence and quality of life for patients with postmenopausal nonmetastatic estrogen receptor–positive breast cancer will be explored. Methods: This study follows a multistage research plan. In stage 1, a systematic literature review to establish an overview of aromatase inhibitor–related symptoms reported by postmenopausal women with nonmetastatic estrogen receptor–positive breast cancer will be completed. In stage 2, a comprehensive overview of symptoms related to aromatase inhibitors (letrozole, exemestane, and anastrozole) will be performed (eg, by reviewing medical leaflets and guidelines). In stage 3, an electronic app with a user-friendly Patient Concern Inventory list to comprise symptoms and concerns will be developed. Last, in stage 4, a convergent mixed methods feasibility study of the pilot version of the Bone@BC app will be conducted. A total of 45 patients with postmenopausal nonmetastatic estrogen receptor–positive breast cancer will use the app daily for symptom identification and respond to 6 serial patient-reported outcome measurements for 12 weeks. Finally, semistructured interviews will be performed. The primary outcome includes consent rate, attrition rate, retention rates, technical issues, and adherence, assessed using preestablished criteria on feasibility and a mixed methods approach for exploring acceptability. A patient advisory board consisting of 5 women with breast cancer is recruited to include their perspectives and experiences in the planning, organization, implementation, and dissemination of the research throughout the project. Results: At the time of submitting this paper (January 2024), a total of 23 patients have been included in the stage 2 medical audit over the recruitment period of 3 months (November 2022 to February 2023), and 19 patients have been enrolled in stage 2, the semistructured patient interviews. Conclusions: This protocol describes a study investigating the feasibility, acceptability, and usability of the symptom management tool Bone@BC developed for patients with breast cancer with an endocrine aspect. Trial Registration: ClinicalTrails.gov NCT05367830; https://clinicaltrials.gov/ct2/show/NCT05367830 International Registered Report Identifier (IRRID): DERR1-10.2196/49549 
SN  - 1929-0748
UR  - https://www.researchprotocols.org/2024/1/e49549
UR  - https://doi.org/10.2196/49549
UR  - http://www.ncbi.nlm.nih.gov/pubmed/38358787
DO  - 10.2196/49549
ID  - info:doi/10.2196/49549
ER  -