TY - JOUR
T1 - Switching Breast Cancer Patients with Progressive Bone Metastases to Third-Generation Bisphosphonates
T2 - Measuring Impact Using the Functional Assessment of Cancer Therapy-Bone Pain
AU - Broom, Reuben
AU - Du, Hongyan
AU - Clemons, Mark
AU - Eton, David
AU - Dranitsaris, George
AU - Simmons, Christine
AU - Ooi, Wei
AU - Cella, David
PY - 2009/8
Y1 - 2009/8
N2 - 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.
AB - 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.
KW - Bone pain scale
KW - bisphosphonates
KW - bone metastases
KW - treatment
KW - validation
UR - http://www.scopus.com/inward/record.url?scp=67651163927&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=67651163927&partnerID=8YFLogxK
U2 - 10.1016/j.jpainsymman.2008.08.005
DO - 10.1016/j.jpainsymman.2008.08.005
M3 - Article
C2 - 19364633
AN - SCOPUS:67651163927
SN - 0885-3924
VL - 38
SP - 244
EP - 257
JO - Journal of pain and symptom management
JF - Journal of pain and symptom management
IS - 2
ER -