Timothy P Pearman1,2,3, Jennifer L Beaumont1, Daniel Mroczek1, Mary O'Connor1, David Cella1,2,4. 1. Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois. 2. Department of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois. 3. Supportive Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois. 4. Prevention and Control Research, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois.
Abstract
BACKGROUND: The improving efficacy of cancer treatment has resulted in an increasing array of treatment-related symptoms and associated burdens imposed on individuals undergoing aggressive treatment of their disease. Often, clinical trials compare therapies that have different types, and severities, of adverse effects. Whether rated by clinicians or patients themselves, it can be difficult to know which side effect profile is more disruptive or bothersome to patients. A simple summary index of bother can help to adjudicate the variability in adverse effects across treatments being compared with each other. METHODS: Across 4 studies, a total of 5765 patients enrolled in cooperative group studies and industry-sponsored clinical trials were the subjects of the current study. Patients were diagnosed with a range of primary cancer sites, including bladder, brain, breast, colon/rectum, head/neck, hepatobiliary, kidney, lung, ovary, pancreas, and prostate as well as leukemia and lymphoma. All patients were administered the Functional Assessment of Cancer Therapy-General version (FACT-G). The single item "I am bothered by side effects of treatment" (GP5), rated on a 5-point Likert scale, is part of the FACT-G. To determine its validity as a useful summary measure from the patient perspective, it was correlated with individual and aggregated clinician-rated adverse events and patient reports of their general ability to enjoy life. RESULTS: Analyses of pharmaceutical trials demonstrated that mean GP5 scores ("I am bothered by side effects of treatment") significantly differed by maximum adverse event grade (P<.001) in all trials, with a clear trend toward increasing GP5 scores with level of increasing adverse event grade. Effect sizes ranged from 0.13 to 0.46. Analyses of cooperative group trials demonstrated a significant correlation between GP5 and item GF3 ("I am able to enjoy life") in the predicted direction. CONCLUSIONS: The single FACT-G item "I am bothered by side effects of treatment" is significantly associated with clinician-reported adverse events and with patients' ability to enjoy their lives. It has promise as an overall summary measure of the burden of a given set of treatment toxicities compared with another. Future research can identify the contribution of individual side effects compared with one another in terms of how each may contribute to overall bother. Cancer 2018;124:991-7.
BACKGROUND: The improving efficacy of cancer treatment has resulted in an increasing array of treatment-related symptoms and associated burdens imposed on individuals undergoing aggressive treatment of their disease. Often, clinical trials compare therapies that have different types, and severities, of adverse effects. Whether rated by clinicians or patients themselves, it can be difficult to know which side effect profile is more disruptive or bothersome to patients. A simple summary index of bother can help to adjudicate the variability in adverse effects across treatments being compared with each other. METHODS: Across 4 studies, a total of 5765 patients enrolled in cooperative group studies and industry-sponsored clinical trials were the subjects of the current study. Patients were diagnosed with a range of primary cancer sites, including bladder, brain, breast, colon/rectum, head/neck, hepatobiliary, kidney, lung, ovary, pancreas, and prostate as well as leukemia and lymphoma. All patients were administered the Functional Assessment of Cancer Therapy-General version (FACT-G). The single item "I am bothered by side effects of treatment" (GP5), rated on a 5-point Likert scale, is part of the FACT-G. To determine its validity as a useful summary measure from the patient perspective, it was correlated with individual and aggregated clinician-rated adverse events and patient reports of their general ability to enjoy life. RESULTS: Analyses of pharmaceutical trials demonstrated that mean GP5 scores ("I am bothered by side effects of treatment") significantly differed by maximum adverse event grade (P<.001) in all trials, with a clear trend toward increasing GP5 scores with level of increasing adverse event grade. Effect sizes ranged from 0.13 to 0.46. Analyses of cooperative group trials demonstrated a significant correlation between GP5 and item GF3 ("I am able to enjoy life") in the predicted direction. CONCLUSIONS: The single FACT-G item "I am bothered by side effects of treatment" is significantly associated with clinician-reported adverse events and with patients' ability to enjoy their lives. It has promise as an overall summary measure of the burden of a given set of treatment toxicities compared with another. Future research can identify the contribution of individual side effects compared with one another in terms of how each may contribute to overall bother. Cancer 2018;124:991-7.
Authors: Elizabeth A Hahn; G Alastair Glendenning; Mark V Sorensen; Stacie A Hudgens; Brian J Druker; Francois Guilhot; Richard A Larson; Stephen G O'Brien; Deborah G Dobrez; Martee L Hensley; David Cella Journal: J Clin Oncol Date: 2003-06-01 Impact factor: 44.544
Authors: Giuseppe Saglio; Dong-Wook Kim; Surapol Issaragrisil; Philipp le Coutre; Gabriel Etienne; Clarisse Lobo; Ricardo Pasquini; Richard E Clark; Andreas Hochhaus; Timothy P Hughes; Neil Gallagher; Albert Hoenekopp; Mei Dong; Ariful Haque; Richard A Larson; Hagop M Kantarjian Journal: N Engl J Med Date: 2010-06-05 Impact factor: 91.245
Authors: Karen Kaiser; Jennifer L Beaumont; Kimberly Webster; Susan E Yount; Lynne I Wagner; Timothy M Kuzel; David Cella Journal: Cancer Med Date: 2015-01-26 Impact factor: 4.452
Authors: D Cella; B Escudier; B Rini; C Chen; H Bhattacharyya; J Tarazi; B Rosbrook; S Kim; R Motzer Journal: Br J Cancer Date: 2013-04-11 Impact factor: 7.640
Authors: David Cella; Robert J Motzer; Brian I Rini; Joseph C Cappelleri; Krishnan Ramaswamy; Subramanian Hariharan; Bhakti Arondekar; Andrew G Bushmakin Journal: Value Health Date: 2018-05-11 Impact factor: 5.725
Authors: Uma N Rao; Laurie E McLouth; Yue Zheng; Stephanie Smith; F Stephen Hodi; Gary I Cohen; Thomas T Amatruda; Shaker R Dakhil; Brendan D Curti; Ibrahim Nakhoul; Sreenivasa R Chandana; Charles L Bane; David E Marinier; Sandra J Lee; Vernon K Sondak; John M Kirkwood; Ahmad A Tarhini; Lynne I Wagner Journal: Qual Life Res Date: 2022-08-27 Impact factor: 3.440
Authors: Giulia I Lane; Ji Qi; Ajith Dupati; Stephanie Ferrante; Rodney L Dunn; Roshan Paudel; Daniela Wittmann; Lauren P Wallner; Donna L Berry; Chad Ellimoottil; James E Montie; J Quentin Clemens Journal: Urology Date: 2022-02-24 Impact factor: 2.633
Authors: David Cella; Robert J Motzer; Cristina Suarez; Steven I Blum; Flavia Ejzykowicz; Melissa Hamilton; Joel F Wallace; Burcin Simsek; Joshua Zhang; Cristina Ivanescu; Andrea B Apolo; Toni K Choueiri Journal: Lancet Oncol Date: 2022-01-12 Impact factor: 54.433
Authors: Lynne I Wagner; Fengmin Zhao; Paul E Goss; Judith-Anne W Chapman; Lois E Shepherd; Timothy J Whelan; Bassam I Mattar; Jose A Bufill; William C Schultz; Irving E LaFrancis; Gauri G Nagargoje; Radhakrishna Vemuri; Daniel A Nikcevich; George W Sledge; David Cella Journal: Breast Cancer Res Treat Date: 2018-02-17 Impact factor: 4.872
Authors: Joshua Z Drago; Mithat Gönen; Gita Thanarajasingam; Chana A Sacks; Michael J Morris; Philip W Kantoff; Konrad H Stopsack Journal: J Natl Cancer Inst Date: 2021-05-04 Impact factor: 13.506
Authors: Houssein Safa; Monica Tamil; Philippe E Spiess; Brandon Manley; Julio Pow-Sang; Scott M Gilbert; Firas Safa; Brian D Gonzalez; Laura B Oswald; Adele Semaan; Adi Diab; Jad Chahoud Journal: J Natl Cancer Inst Date: 2021-05-04 Impact factor: 13.506
Authors: Marie A Flannery; Eva Culakova; Beverly E Canin; Luke Peppone; Erika Ramsdale; Supriya G Mohile Journal: J Clin Oncol Date: 2021-05-27 Impact factor: 44.544