A prospective, multicenter, longitudinal study to evaluate the long-term quality of life and associated factors in breast cancer survivors, 5-year follow-up: A study protocol

Breast cancer is the most common cancer among women, with its prevalence and mortality rates increasing in recent years. The quality of life and psychological status of patients with breast cancer could be affected after diagnosis, especially during treatment. The main objective of this study is to investigate the long-term influence of breast cancer on the quality of life dimensions in survivors.

This is an ongoing longitudinal prospective study that was administered at the National Institute for Medical Research Development in Iran in March 2020. A total of 1,200 patients with breast cancer, who have completed their treatments, will be recruited from 5 referral medical centers located in Tehran to be followed for 5 years. Questionnaires for evaluating the primary and secondary outcomes will be completed by trained investigators during face-to-face interviews with each participant in three phases: immediately after treatment, 1 year later, and 5 years later. Data will be collected on socio-demographic status, quality of life, body image, hope, psychological problems (e.g., anxiety, depression, and mood), sexual function, and physical activity. Finally, data will be analyzed in each phase using SPSS 22.0 software.

It is the first nationwide, prospective, longitudinal study with large sample size, long-term follow-up, and broad research aims that will evaluate the quality of life-related factors in the Iranian breast cancer population to justify the existing gap in the literature.