A prospective observational study of patient-reported functioning and quality of life in advanced and metastatic breast cancer utilizing a novel mobile application

David Richardson, Lin Zhan, Reshma Mahtani, Lynn McRoy, Debanjali Mitra, Maria Reynolds, Dawn Odom, Kelly Hollis, James A. Kaye, Cheryl Jones, Jeffrey Hargis

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: To assess and describe patient-reported outcomes (PROs) in women with locally advanced/unresectable or metastatic breast cancer (aBC/mBC) with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR + /HER2 −) status receiving palbociclib combination therapy in a US real-world setting. Methods: A prospective, noninterventional, multicenter longitudinal study was conducted in US patients initiating treatment with palbociclib combination therapy for HR + /HER2 − aBC/mBC. PRO data (SF-12; CES-D-10; mood; pain; fatigue; interference of aBC/mBC or its treatment on family life, social life, physical activity, energy, and productivity; overall health rating; and quality of life [QOL]) were collected via a custom-developed mobile application at daily, weekly, and cycle-based intervals. Patient medical information (demographics, clinical characteristics, treatment information, and adverse events) was collected from medical records at baseline and at the end of the 6-month follow-up period. Results: Patients’ general health status (SF-12) remained consistent throughout treatment and was generally consistent with published norms for individuals diagnosed with cancer. The presence of depression (CES-D-10) was low and did not change substantially over time. Mean pain and fatigue scores using an 11-point numeric rating scale were low and remained stable. Patients, on average, reported neutral or positive moods. Patient-reported QOL and overall health was primarily “Good,” “Very good,” or “Excellent.” Findings were consistent regardless of patient experience with neutropenia. Conclusions: Patients treated with palbociclib, on average, reported consistently low levels of pain and fatigue as well as good QOL and overall health that remained stable throughout the first 6 months of treatment regardless of episodes of neutropenia.

Original languageEnglish (US)
Pages (from-to)113-124
Number of pages12
JournalBreast cancer research and treatment
Volume187
Issue number1
DOIs
StatePublished - May 2021

Keywords

  • Advanced breast cancer
  • Cyclin-dependent kinase 4/6
  • Metastatic breast cancer
  • Palbociclib
  • Patient-reported outcomes

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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