OBJECTIVES: By using methods consistent with recent regulatory guidance on patient-reported outcomes as endpoints in clinical trials, we created a new version of the Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index (FBSI), with emphasis on patient input during the development process. METHODS: We obtained input on the most important symptoms to monitor during treatment for stage III or IV breast cancer from 52 patients recruited from National Comprehensive Cancer Network institutions as well as support service organizations. Participating patients shared their top-priority symptoms/concerns through open-ended interviews and symptom checklists. To ensure adequate content coverage, we evaluated results alongside the original version of the FBSI, which was created on the basis of a survey of oncology clinicians at National Comprehensive Cancer Network institutions and items in the Functional Assessment of Chronic Illness Therapy measurement system. We also obtained input from 10 National Comprehensive Cancer Network oncologists regarding whether symptoms were primarily related to disease or treatment. RESULTS: We selected breast cancer-related symptoms and concerns endorsed as high priority by both oncology patients and clinicians for inclusion in the new National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index-16 (NFBSI-16), which includes all eight items from the original FBSI and eight additional items from Functional Assessment of Chronic Illness Therapy measures. The NFBSI-16 is formatted by subscale: Disease-Related Symptom, Treatment Side-Effect, and General Function and Well-Being. Results provide preliminary support for NFBSI-16's internal consistency reliability (α = 0.87) and validity as evidenced by moderate-to-strong relationships with expected criteria. CONCLUSIONS: Reflecting the priority symptoms of breast cancer patients and clinicians, the NFBSI-16 can be used to help evaluate the effectiveness of treatments for advanced breast cancer in clinical practice and research.
OBJECTIVES: By using methods consistent with recent regulatory guidance on patient-reported outcomes as endpoints in clinical trials, we created a new version of the Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index (FBSI), with emphasis on patient input during the development process. METHODS: We obtained input on the most important symptoms to monitor during treatment for stage III or IV breast cancer from 52 patients recruited from National Comprehensive Cancer Network institutions as well as support service organizations. Participating patients shared their top-priority symptoms/concerns through open-ended interviews and symptom checklists. To ensure adequate content coverage, we evaluated results alongside the original version of the FBSI, which was created on the basis of a survey of oncology clinicians at National Comprehensive Cancer Network institutions and items in the Functional Assessment of Chronic Illness Therapy measurement system. We also obtained input from 10 National Comprehensive Cancer Network oncologists regarding whether symptoms were primarily related to disease or treatment. RESULTS: We selected breast cancer-related symptoms and concerns endorsed as high priority by both oncology patients and clinicians for inclusion in the new National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index-16 (NFBSI-16), which includes all eight items from the original FBSI and eight additional items from Functional Assessment of Chronic Illness Therapy measures. The NFBSI-16 is formatted by subscale: Disease-Related Symptom, Treatment Side-Effect, and General Function and Well-Being. Results provide preliminary support for NFBSI-16's internal consistency reliability (α = 0.87) and validity as evidenced by moderate-to-strong relationships with expected criteria. CONCLUSIONS: Reflecting the priority symptoms of breast cancerpatients and clinicians, the NFBSI-16 can be used to help evaluate the effectiveness of treatments for advanced breast cancer in clinical practice and research.
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Authors: Jessica Alonso-Molero; Antonio J Molina; Jose Juan Jiménez-Moleón; Beatriz Pérez-Gómez; Vicente Martin; Victor Moreno; Pilar Amiano; Eva Ardanaz; Silvia de Sanjose; Inmaculada Salcedo; Guillermo Fernandez-Tardon; Juan Alguacil; Dolores Salas; Rafael Marcos-Gragera; Maria Dolores Chirlaque; Nuria Aragonés; Gemma Castaño-Vinyals; Marina Pollán; Manolis Kogevinas; Javier Llorca Journal: BMJ Open Date: 2019-11-21 Impact factor: 2.692
Authors: Jéssica Alonso-Molero; Trinidad Dierssen-Sotos; Ines Gomez-Acebo; Nerea Fernandez de Larrea Baz; Marcela Guevara; Pilar Amiano; Gemma Castaño-Vinyals; Tania Fernandez-Villa; Victor Moreno; Juan Bayo; Ana Molina-Barceloa; María Fernández-Ortíz; Claudia Suarez-Calleja; Rafael Marcos-Gragera; Xavier Castells; Leire Gil-Majuelo; Eva Ardanaz; Beatriz Pérez-Gómez; Manolis Kogevinas; Marina Pollán; Javier Llorca Journal: Int J Environ Res Public Health Date: 2020-11-13 Impact factor: 3.390