JMIR Publications

ABSTRACT

Background:

Patients with postmenopausal non-metastatic Estrogen Receptor-positive breast cancer often experience a reduced quality of life after primary treatment. The disease and treatment trajectory consist of surgery followed by chemotherapy and/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:

A twofold aim to 1) develop an electronic symptom management tool for postmenopausal early breast cancer patients receiving maintenance aromatase inhibitors with an endocrine aspect and 2) assess the feasibility, acceptability, and usability of the pilot vision app Bone@BC. Furthermore, longitudinally, symptom prevalence and quality of life for patients with postmenopausal non-metastatic Estrogen Receptor-positive breast cancer will be explored.

Methods:

This study follows a multistage research plan: Stage 1: A systematic literature review to establish an overview of aromatase inhibitor-related symptoms reported by postmenopausal women with non-metastatic Estrogen Receptor-positive breast cancer will be completed. Stage 2: A comprehensive overview of symptoms related to aromatase inhibitors (Letrozole, Exemestane, and Anastrozole) will be performed e.g., by a review of medical leaflets, and guidelines. Stage 3: Develop an electronic app user-friendly Patient Concern Inventory List to comprise symptoms and concerns. Stage 4: A convergent mixed-methods feasibility study of the pilot version Bone@BC app. Forty to fifty patients with postmenopausal non-metastatic Estrogen Receptor-positive breast cancer will use the app daily for symptom identification and respond to six serial patient-reported outcome measurements for 12 weeks. Finally, semi-structured interviews will be performed. The primary outcome includes consent rate, attrition rate, retention rates, technical issues, and adherence, assessed using pre-established criteria on feasibility, and a mixed-methods approach for exploring the acceptability. A patient advisory board consisting of five 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 (June 2023) 23 patients have been included in stage 2 medical audit over the recruitment period of three months (November 2022 – February 2023) and a total of 6 patients have been enrolled in stage 2 the semi-structured patient interviews.

Conclusions:

This protocol describes a study investigating the feasibility, acceptability and usability of the symptom management tool Bone@BC app developed for patients with breast cancer with an endocrine aspect. Clinical Trial: Trial Registration: ClinicalTrails.gov, NCT05367830. Registered on April 19, 2022, https://clinicaltrials.gov/ct2/show/NCT05367830.