Principal Investigator

Supriya G
Mohile
Awardee Organization

University Of Rochester
United States

Fiscal Year
2018
Activity Code
R01
Project End Date

Reducing Chemotherapy Toxicity in Older Adults

Over 60% of cancers occur in older persons, and the number of older cancer patients is expected to grow as the population ages. Older cancer patients are at increased risk of treatment complications, and there is no standard approach for reducing chemotherapy toxicity. Several studies, including a Cancer and Aging Research Group (CARG) study in 500 patients, have demonstrated that 50% of older patients have severe toxicity from chemotherapy within 3 months of treatment initiation and that measures within a geriatric assessment (GA), a validated approach to assessing health status in older persons, can predict severe chemotherapy toxicities. Although geriatric assessment has great potential to improve adverse outcomes of older adults with cancer, the majority of oncologists have not adopted GA, largely because of lack of knowledge on how to best incorporate GA into clinical care. The overall hypothesis of this proposed research is that providing oncologists with information from geriatric assessment with and targeted interventions guided by GA for older patients can reduce the risk of chemotherapy toxicity. The principal investigator, a geriatric oncologist, and the research team assembled through CARG are well positioned to successfully complete this high-impact research. The study will be conducted in 2 phases. In Phase 1, patients aged 70 and over (n=240) with metastatic solid tumor malignancies who are planning to receive first-line chemotherapy at University of Rochester Community Clinical Oncology Program (CCOP) sites will be recruited over the course of 1 year. "Usual-care" practices including physician characteristics, prescribing patterns, patient and physician decision-making for chemotherapy initiation, and chemotherapy toxicity will be captured. In Phase 2, we will conduct a 2-armed cluster randomized study utilizing CCOP sites. Prior to chemotherapy initiation, patients aged 70 and over (n=688) with metastatic solid tumor malignancies will complete a GA. The oncologists at sites randomized to Arm 1 will receive a summary of GA results plus targeted interventions to consider for implementation. In Arm 2, oncologists will only receive information from GA regarding severe depression or cognitive impairment. The primary outcome will be a comparison of the proportion of patients who have severe chemotherapy toxicity at 3 months after chemotherapy initiation. Secondary outcomes will include comparisons of survival, the number of interventions implemented in both groups, and decision-making for chemotherapy. An exploratory aim will evaluate whether or not GA plus targeted interventions can slow functional and physical decline in older patients with advanced cancer. With regard to expected outcomes, this proposal will fill vital gaps in knowledge regarding whether GA can improve outcomes of older cancer patients and the mechanisms of how GA can improve quality of life (decisions, GA-driven interventions). These data will have a positive impact by providing a pragmatic mechanism for incorporating GA into routine clinical oncology care to improve outcomes of older adults with metastatic cancer.

Publications

  • Sajid S, Dale W, Mustian K, Kotwal A, Heckler C, Porto M, Fung C, Mohile SG. Novel physical activity interventions for older patients with prostate cancer on hormone therapy: A pilot randomized study. Journal of geriatric oncology. 2016 Mar;7(2):71-80. Epub 2016 Feb 23. PMID: 26916611
  • Kehoe LA, Xu H, Duberstein P, Loh KP, Culakova E, Canin B, Hurria A, Dale W, Wells M, Gilmore N, Kleckner AS, Lund J, Kamen C, Flannery M, Hoerger M, Hopkins JO, Liu JJ, Geer J, Epstein R, Mohile SG. Quality of Life of Caregivers of Older Patients with Advanced Cancer. Journal of the American Geriatrics Society. 2019 May;67(5):969-977. Epub 2019 Mar 29. PMID: 30924548
  • Ramsdale E, Snyder E, Culakova E, Xu H, Dziorny A, Yang S, Zand M, Anand A. An introduction to machine learning for clinicians: How can machine learning augment knowledge in geriatric oncology? Journal of geriatric oncology. 2021 Nov;12(8):1159-1163. Epub 2021 Mar 29. PMID: 33795205
  • Mohile S, Dale W, Magnuson A, Kamath N, Hurria A. Research priorities in geriatric oncology for 2013 and beyond. Cancer forum. 2013 Nov;37(3):216-221. PMID: 25346565
  • Mohamed MR, Ramsdale E, Loh KP, Xu H, Patil A, Gilmore N, Obrecht S, Wells M, Nightingale G, Juba KM, Faller B, Onitilo A, Bradley T, Culakova E, Holmes H, Mohile SG. Association of Polypharmacy and Potentially Inappropriate Medications With Physical Functional Impairments in Older Adults With Cancer. Journal of the National Comprehensive Cancer Network : JNCCN. 2021 Jan 22;19(3):267-274. PMID: 33482631
  • Lund JL, Duberstein PR, Loh KP, Gilmore N, Plumb S, Lei L, Keil AP, Islam JY, Hanson LC, Giguere JK, Vogel VG, Burnette BL, Mohile SG. Life expectancy in older adults with advanced cancer: Evaluation of a geriatric assessment-based prognostic model. Journal of geriatric oncology. 2022 Mar;13(2):176-181. Epub 2021 Sep 2. PMID: 34483079
  • Hurria A, Dale W, Mooney M, Rowland JH, Ballman KV, Cohen HJ, Muss HB, Schilsky RL, Ferrell B, Extermann M, Schmader KE, Mohile SG, Cancer and Aging Research Group. Designing therapeutic clinical trials for older and frail adults with cancer: U13 conference recommendations. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2014 Aug 20;32(24):2587-94. PMID: 25071116
  • Mohile SG, Velarde C, Hurria A, Magnuson A, Lowenstein L, Pandya C, O'Donovan A, Gorawara-Bhat R, Dale W. Geriatric Assessment-Guided Care Processes for Older Adults: A Delphi Consensus of Geriatric Oncology Experts. Journal of the National Comprehensive Cancer Network : JNCCN. 2015 Sep;13(9):1120-30. PMID: 26358796
  • O'Donovan A, Mohile SG, Leech M. Expert consensus panel guidelines on geriatric assessment in oncology. European journal of cancer care. 2015 Jul;24(4):574-89. Epub 2015 Mar 11. PMID: 25757457
  • Wildiers H, Heeren P, Puts M, Topinkova E, Janssen-Heijnen ML, Extermann M, Falandry C, Artz A, Brain E, Colloca G, Flamaing J, Karnakis T, Kenis C, Audisio RA, Mohile S, Repetto L, Van Leeuwen B, Milisen K, Hurria A. International Society of Geriatric Oncology consensus on geriatric assessment in older patients with cancer. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2014 Aug 20;32(24):2595-603. PMID: 25071125
  • DiGiovanni G, Mousaw K, Lloyd T, Dukelow N, Fitzgerald B, D'Aurizio H, Loh KP, Mohile S, Ramsdale E, Maggiore R, Zittel J, Kadambi S, Magnuson A. Development of a telehealth geriatric assessment model in response to the COVID-19 pandemic. Journal of geriatric oncology. 2020 Jun;11(5):761-763. Epub 2020 Apr 17. PMID: 32327321
  • Ramsdale E, Mohamed M, Yu V, Otto E, Juba K, Awad H, Moorthi K, Plumb S, Patil A, Vogelzang N, Dib E, Mohile S. Polypharmacy, Potentially Inappropriate Medications, and Drug-Drug Interactions in Vulnerable Older Adults With Advanced Cancer Initiating Cancer Treatment. The oncologist. 2022 Jul 5;27(7):e580-e588. PMID: 35348764
  • Williams GR, Mackenzie A, Magnuson A, Olin R, Chapman A, Mohile S, Allore H, Somerfield MR, Targia V, Extermann M, Cohen HJ, Hurria A, Holmes H. Comorbidity in older adults with cancer. Journal of geriatric oncology. 2016 Jul;7(4):249-57. Epub 2015 Dec 22. PMID: 26725537
  • Flannery MA, Culakova E, Canin BE, Peppone L, Ramsdale E, Mohile SG. Understanding Treatment Tolerability in Older Adults With Cancer. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2021 Jul 1;39(19):2150-2163. Epub 2021 May 27. PMID: 34043433
  • Loh KP, McHugh C, Mohile SG, Mustian K, Flannery M, Klepin H, Schnall R, Culakova E, Ramsdale E. Using Information Technology in the Assessment and Monitoring of Geriatric Oncology Patients. Current oncology reports. 2018 Mar 6;20(3):25. PMID: 29511850
  • Loh KP, Kaushik R, Mohile SG, Ogie S, Kadambi S, Zittel J, Yousefi-Nooraie R, Moorthi K, Patil A, Sanapala C, Yang S, Ramsdale E. Speeding the dissemination and implementation of geriatric assessment: What we can learn from the business world. Journal of geriatric oncology. 2020 Sep;11(7):1170-1174. Epub 2020 Mar 24. PMID: 32220588
  • Mohile S, Dumontier C, Mian H, Loh KP, Williams GR, Wildes TM, Boyd K, Ramsdale E, Pyne S, Magnuson A, Tew W, Klepin HD, Dale W, Shahrokni A. Perspectives from the Cancer and Aging Research Group: Caring for the vulnerable older patient with cancer and their caregivers during the COVID-19 crisis in the United States. Journal of geriatric oncology. 2020 Jun;11(5):753-760. Epub 2020 Apr 21. PMID: 32340908
  • Mohile SG, Dale W, Somerfield MR, Hurria A. Practical Assessment and Management of Vulnerabilities in Older Patients Receiving Chemotherapy: ASCO Guideline for Geriatric Oncology Summary. Journal of oncology practice. 2018 Jul;14(7):442-446. Epub 2018 Jun 22. PMID: 29932846
  • Gilmore N, Kehoe L, Bauer J, Xu H, Hall B, Wells M, Lei L, Culakova E, Flannery M, Grossman VA, Sardari RA, Subramanya H, Kadambi S, Belcher E, Kettinger J, O'Rourke MA, Dib EG, Vogelzang NJ, Dale W, Mohile S. The Relationship Between Frailty and Emotional Health in Older Patients with Advanced Cancer. The oncologist. 2021 Dec;26(12):e2181-e2191. Epub 2021 Sep 19. PMID: 34510642
  • Magnuson A, Mohile S, Janelsins M. Cognition and Cognitive Impairment in Older Adults with Cancer. Current geriatrics reports. 2016 Sep;5(3):213-219. Epub 2016 Jun 29. PMID: 27547701
  • Mohile SG, Mohamed MR, Xu H, Culakova E, Loh KP, Magnuson A, Flannery MA, Obrecht S, Gilmore N, Ramsdale E, Dunne RF, Wildes T, Plumb S, Patil A, Wells M, Lowenstein L, Janelsins M, Mustian K, Hopkins JO, Berenberg J, Anthony N, Dale W. Evaluation of geriatric assessment and management on the toxic effects of cancer treatment (GAP70+): a cluster-randomised study. Lancet (London, England). 2021 Nov 20;398(10314):1894-1904. Epub 2021 Nov 3. PMID: 34741815
  • Culakova E, Mohile SG, Peppone L, Ramsdale E, Mohamed M, Xu H, Wells M, Tylock R, Java J, Loh KP, Magnuson A, Jamieson L, Vogel V, Duberstein PR, Chapman BP, Dale W, Flannery MA. Effects of a Geriatric Assessment Intervention on Patient-Reported Symptomatic Toxicity in Older Adults With Advanced Cancer. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2023 Feb 1;41(4):835-846. Epub 2022 Nov 10. PMID: 36356279
  • Mohamed MR, Loh KP, Mohile SG, Sohn M, Webb T, Wells M, Yilmaz S, Tylock R, Culakova E, Magnuson A, Sun CL, Bearden J, Hopkins JO, Faller BA, Klepin HD. External Validation of Risk Factors for Unplanned Hospitalization in Older Adults With Advanced Cancer Receiving Chemotherapy. Journal of the National Comprehensive Cancer Network : JNCCN. 2023 Mar;21(3):273-280.e3. PMID: 36898361
  • Otto E, Culakova E, Meng S, Zhang Z, Xu H, Mohile S, Flannery MA. Overview of Sankey flow diagrams: Focusing on symptom trajectories in older adults with advanced cancer. Journal of geriatric oncology. 2022 Jun;13(5):742-746. Epub 2022 Jan 7. PMID: 35000890
  • Dunne RF, Roussel B, Culakova E, Pandya C, Fleming FJ, Hensley B, Magnuson AM, Loh KP, Gilles M, Ramsdale E, Maggiore RJ, Jatoi A, Mustian KM, Dale W, Mohile SG. Characterizing cancer cachexia in the geriatric oncology population. Journal of geriatric oncology. 2019 May;10(3):415-419. Epub 2018 Sep 5. PMID: 30196027
  • Magnuson A, Dale W, Mohile S. Models of Care in Geriatric Oncology. Current geriatrics reports. 2014 Sep;3(3):182-189. PMID: 25587518
  • Loh KP, Duberstein P, Zittel J, Lei L, Culakova E, Xu H, Plumb S, Flannery MA, Magnuson A, Bautista J, Wittink M, Gilmore N, Targia V, Conlin A, Berenberg J, Vogel VG, Mohile SG. Relationships of self-perceived age with geriatric assessment domains in older adults with cancer. Journal of geriatric oncology. 2020 Jul;11(6):1006-1010. Epub 2019 Dec 30. PMID: 31899198
  • Magnuson A, Lemelman T, Pandya C, Goodman M, Noel M, Tejani M, Doughtery D, Dale W, Hurria A, Janelsins M, Lin FV, Heckler C, Mohile S. Geriatric assessment with management intervention in older adults with cancer: a randomized pilot study. Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2018 Feb;26(2):605-613. Epub 2017 Sep 15. PMID: 28914366
  • Mohile SG, Dale W, Somerfield MR, Schonberg MA, Boyd CM, Burhenn PS, Canin B, Cohen HJ, Holmes HM, Hopkins JO, Janelsins MC, Khorana AA, Klepin HD, Lichtman SM, Mustian KM, Tew WP, Hurria A. Practical Assessment and Management of Vulnerabilities in Older Patients Receiving Chemotherapy: ASCO Guideline for Geriatric Oncology. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2018 Aug 1;36(22):2326-2347. Epub 2018 May 21. PMID: 29782209
  • Sharma M, Loh KP, Nightingale G, Mohile SG, Holmes HM. Polypharmacy and potentially inappropriate medication use in geriatric oncology. Journal of geriatric oncology. 2016 Sep;7(5):346-53. Epub 2016 Aug 3. PMID: 27498305
  • Kadambi S, Loh KP, Dunne R, Magnuson A, Maggiore R, Zittel J, Flannery M, Inglis J, Gilmore N, Mohamed M, Ramsdale E, Mohile S. Older adults with cancer and their caregivers - current landscape and future directions for clinical care. Nature reviews. Clinical oncology. 2020 Dec;17(12):742-755. Epub 2020 Sep 2. PMID: 32879429
  • Loh KP, Mohile SG, Epstein RM, McHugh C, Flannery M, Culakova E, Lei L, Wells M, Gilmore N, Babu D, Whitehead MI, Dale W, Hurria A, Wittink M, Magnuson A, Conlin A, Thomas M, Berenberg J, Duberstein PR. Willingness to bear adversity and beliefs about the curability of advanced cancer in older adults. Cancer. 2019 Jul 15;125(14):2506-2513. Epub 2019 Mar 28. PMID: 30920646
  • Lowenstein LM, Ouellet JA, Dale W, Fan L, Gupta Mohile S. Preventive care in older cancer survivors. Journal of geriatric oncology. 2015 Mar;6(2):85-92. Epub 2014 Dec 24. PMID: 25547206
  • Pandya C, Magnuson A, Flannery M, Zittel J, Duberstein P, Loh KP, Ramsdale E, Gilmore N, Dale W, Mohile SG. Association Between Symptom Burden and Physical Function in Older Patients with Cancer. Journal of the American Geriatrics Society. 2019 May;67(5):998-1004. Epub 2019 Mar 8. PMID: 30848838
  • Gewandter JS, Dale W, Magnuson A, Pandya C, Heckler CE, Lemelman T, Roussel B, Ifthikhar R, Dolan J, Noyes K, Mohile SG. Associations between a patient-reported outcome (PRO) measure of sarcopenia and falls, functional status, and physical performance in older patients with cancer. Journal of geriatric oncology. 2015 Nov;6(6):433-41. Epub 2015 Sep 11. PMID: 26365897
  • Mohamed MR, Kyi K, Mohile SG, Xu H, Culakova E, Loh KP, Flannery M, Obrecht S, Ramsdale E, Patil A, Dunne RF, DiGiovanni G, Hezel A, Burnette B, Desai N, Giguere J, Magnuson A. Prevalence of and factors associated with treatment modification at first cycle in older adults with advanced cancer receiving palliative treatment. Journal of geriatric oncology. 2021 Nov;12(8):1208-1213. Epub 2021 Jul 14. PMID: 34272204
  • Gilmore NJ, Canin B, Whitehead M, Sedenquist M, Griggs L, Finch L, Grossman V, Targia V, Wells M, Kamen C, Flannery M, Magnuson A, Plumb S, Obrecht S, Lowenstein LM, Lopez G, Anderson J, Berenberg J, Vogel V, Bearden J, Dale W, Mohile SG. Engaging older patients with cancer and their caregivers as partners in cancer research. Cancer. 2019 Dec 1;125(23):4124-4133. Epub 2019 Aug 16. PMID: 31420878
  • Mohamed MR, Ramsdale E, Loh KP, Arastu A, Xu H, Obrecht S, Castillo D, Sharma M, Holmes HM, Nightingale G, Juba KM, Mohile SG. Associations of Polypharmacy and Inappropriate Medications with Adverse Outcomes in Older Adults with Cancer: A Systematic Review and Meta-Analysis. The oncologist. 2020 Jan;25(1):e94-e108. Epub 2019 Sep 30. PMID: 31570516
  • Gramling R, Fiscella K, Xing G, Hoerger M, Duberstein P, Plumb S, Mohile S, Fenton JJ, Tancredi DJ, Kravitz RL, Epstein RM. Determinants of Patient-Oncologist Prognostic Discordance in Advanced Cancer. JAMA oncology. 2016 Nov 1;2(11):1421-1426. PMID: 27415765
  • Mohile SG, Magnuson A, Pandya C, Velarde C, Duberstein P, Hurria A, Loh KP, Wells M, Plumb S, Gilmore N, Flannery M, Wittink M, Epstein R, Heckler CE, Janelsins M, Mustian K, Hopkins JO, Liu J, Peri S, Dale W. Community Oncologists' Decision-Making for Treatment of Older Patients With Cancer. Journal of the National Comprehensive Cancer Network : JNCCN. 2018 Mar;16(3):301-309. PMID: 29523669
  • Xu H, Mohamed M, Flannery M, Peppone L, Ramsdale E, Loh KP, Wells M, Jamieson L, Vogel VG, Hall BA, Mustian K, Mohile S, Culakova E. An Unsupervised Machine Learning Approach to Evaluating the Association of Symptom Clusters With Adverse Outcomes Among Older Adults With Advanced Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA network open. 2023 Mar 1;6(3):e234198. PMID: 36947036
  • Flannery M, Mohile SG, Dale W, Arora NK, Azar L, Breslau ES, Cohen HJ, Dotan E, Eldadah BA, Leach CR, Mitchell SA, Rowland JH, Hurria A. Interventions to improve the quality of life and survivorship of older adults with cancer: The funding landscape at NIH, ACS and PCORI. Journal of geriatric oncology. 2016 Jul;7(4):225-33. Epub 2016 Jul 5. PMID: 27197917
  • Verduzco-Aguirre HC, Babu D, Mohile SG, Bautista J, Xu H, Culakova E, Canin B, Zhang Y, Wells M, Epstein RM, Duberstein P, McHugh C, Dale W, Conlin A, Bearden J 3rd, Berenberg J, Tejani M, Loh KP. Associations of Uncertainty With Psychological Health and Quality of Life in Older Adults With Advanced Cancer. Journal of pain and symptom management. 2021 Feb;61(2):369-376.e1. Epub 2020 Aug 19. PMID: 32822750
  • Loh KP, Ramsdale E, Culakova E, Mendler JH, Liesveld JL, O'Dwyer KM, McHugh C, Gilles M, Lloyd T, Goodman M, Klepin HD, Mustian KM, Schnall R, Mohile SG. Novel mHealth App to Deliver Geriatric Assessment-Driven Interventions for Older Adults With Cancer: Pilot Feasibility and Usability Study. JMIR cancer. 2018 Oct 29;4(2):e10296. PMID: 30373733
  • Gilmore N, Xu H, Kehoe L, Kleckner AS, Moorthi K, Lei L, Mohamed MRS, Loh KP, Culakova E, Flannery M, Ramsdale E, Duberstein PR, Canin B, Kamen C, Giri G, Watson E, Patil A, Onitilo AA, Burnette B, Janelsins M, Mohile SG. Evaluating the association of frailty with communication about aging-related concerns between older patients with advanced cancer and their oncologists. Cancer. 2022 Mar 1;128(5):1101-1109. Epub 2021 Nov 11. PMID: 34762734
  • Arastu A, Patel A, Mohile SG, Ciminelli J, Kaushik R, Wells M, Culakova E, Lei L, Xu H, Dougherty DW, Mohamed MR, Hill E, Duberstein P, Flannery MA, Kamen CS, Pandya C, Berenberg JL, Aarne Grossman VG, Liu Y, Loh KP. Assessment of Financial Toxicity Among Older Adults With Advanced Cancer. JAMA network open. 2020 Dec 1;3(12):e2025810. PMID: 33284337
  • Xu H, Kadambi S, Mohile SG, Yang S, Kehoe LA, Wells M, Culakova E, Kamen C, Obrecht S, Mohamed M, Gilmore NJ, Magnuson A, Grossman VA, Hopkins JO, Geer J, Berenberg J, Mustian K, Cupertino A, Mohile N, Loh KP. Caregiving burden of informal caregivers of older adults with advanced cancer: The effects of rurality and education. Journal of geriatric oncology. 2021 Sep;12(7):1015-1021. Epub 2021 Apr 12. PMID: 33858803
  • Magnuson A, Wallace J, Canin B, Chow S, Dale W, Mohile SG, Hamel LM. Shared Goal Setting in Team-Based Geriatric Oncology. Journal of oncology practice. 2016 Nov;12(11):1115-1122. Epub 2016 Sep 30. PMID: 27624949
  • Loh KP, Pandya C, Zittel J, Kadambi S, Flannery M, Reizine N, Magnuson A, Braganza G, Mustian K, Dale W, Duberstein P, Mohile SG. Associations of sleep disturbance with physical function and cognition in older adults with cancer. Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2017 Oct;25(10):3161-3169. Epub 2017 Apr 28. PMID: 28455547
  • Ramsdale E, Lemelman T, Loh KP, Flannery M, Kehoe L, Mullaney T, Wells M, Gilmore N, Plumb S, Mohile S. Geriatric assessment-driven polypharmacy discussions between oncologists, older patients, and their caregivers. Journal of geriatric oncology. 2018 Sep;9(5):534-539. Epub 2018 Mar 9. PMID: 29530495
  • Mohamed MR, Mohile SG, Juba KM, Awad H, Wells M, Loh KP, Flannery M, Culakova E, Tylock RG, Ramsdale EE. Association of polypharmacy and potential drug-drug interactions with adverse treatment outcomes in older adults with advanced cancer. Cancer. 2023 Apr 1;129(7):1096-1104. Epub 2023 Jan 24. PMID: 36692475
  • Flannery M, Culakova E, Mohile S. Reply to T. Kaneko et al. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2023 May 10;41(14):2666-2667. Epub 2023 Mar 17. PMID: 36930847

Clinical Trials

Study Name Clinical Trial ID
Geriatric Assessment Intervention for Reducing Toxicity in Older Patients With Advanced Cancer NCT02054741