Switching Breast Cancer Patients with Progressive Bone Metastases to Third-Generation Bisphosphonates: Measuring Impact Using the Functional Assessment of Cancer Therapy-Bone Pain

Reuben Broom, Hongyan Du, Mark Clemons, David Eton, George Dranitsaris, Christine Simmons, Wei Ooi, David Cella

Research output: Contribution to journalArticle

37 Scopus citations

Abstract

Because bone metastases cause significant pain, we developed a questionnaire to evaluate its nature, severity, and impact. This 16-item questionnaire is the Functional Assessment of Cancer Therapy-Bone Pain (FACT-BP). We also developed a 13/18-item questionnaire, the Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-Bone Treatment Convenience and Satisfaction Questionnaire (FACIT-TS-BTCSQ), to evaluate patients' expectations and acceptance of bone-specific therapies. We evaluated the performance of these scales in two clinical trials. In both trials, we enrolled patients with metastatic breast cancer, who had progressive bone metastases despite first-line therapy with pamidronate or clodronate. We administered intravenous zoledronic acid to 31 patients in one trial and oral ibandronate to 30 patients in the other. Patients completed the FACT-BP questionnaire and FACIT-TS-BTCSQ at baseline, then at Weeks 4, 8, and 12. The FACT-BP scale showed good internal consistency reliability [Cronbach's alpha (α) = 0.93-0.96]. There was evidence of construct validity, and known-group validity was supported by score shifts in the anticipated direction (Cohen's d effect size = 0.36). The FACT-BP score reflected clinical change as evidenced by differences in performance status. This cross-sectional anchor-based criterion suggested reasonable clinically important differences (effect size = 0.36). The FACIT-TS-BTCSQ showed good internal consistency reliability for treatment expectation (α = 0.87) and treatment experience (α's = 0.89-0.92). The FACT-BP scale is meaningful and appears appropriate for broader use. The assessment of satisfaction (FACIT-TS-BTCSQ) raised questions that will require further research.

Original languageEnglish (US)
Pages (from-to)244-257
Number of pages14
JournalJournal of pain and symptom management
Volume38
Issue number2
DOIs
StatePublished - Aug 1 2009

Keywords

  • Bone pain scale
  • bisphosphonates
  • bone metastases
  • treatment
  • validation

ASJC Scopus subject areas

  • Nursing(all)
  • Clinical Neurology
  • Anesthesiology and Pain Medicine

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