Multicentre prospective cohort study of unmet supportive care needs among patients with breast cancer throughout their cancer treatment trajectory in Penang: a PenBCNeeds Study protocol

INTRODUCTION: Proper assessment of unmet supportive care needs of patients with breast cancer and its influencing factors at different treatment intervals will improve the rehabilitation of patients with breast cancer. Therefore, this study aims to determine the prevalence of unmet supportive care needs, changes of needs over time and associated factors during the treatment period.

METHODS AND ANALYSIS: This multicentre, prospective cohort study will be conducted in three governmental hospitals and one tertiary cancer institute in Penang, Malaysia. Adult women diagnosed with primary or recurrent tumour, node, metastases stage I-IV breast cancer based on pathological biopsy will be eligible for this study. At least 281 samples are required for this study. Participants will undergo follow-up at three time intervals: T1 at breast cancer diagnosis; T2 at 3 months after diagnosis and T3 at 6 months after diagnosis. Patients will complete a set of questionnaires at each time. The primary outcome of this study includes the changes in supportive care needs over three time points, followed by the secondary outcome examining patients' characteristics, coping behaviours and positive psychological components as they affect changes in unmet supportive care needs over time.

ETHICS AND DISSEMINATION: The study has received ethics approval from the Medical Research and Ethics Committee, Ministry of Health Malaysia (NMRR-19-268-45809 IIR) and the Human Research Ethics Committee of Universiti Sains Malaysia (USM/JEPeM/17100443). The results of the prospective study will be submitted for publication in a peer-reviewed journal.