Patient and clinician nudges to improve symptom management in advanced cancer using patient-generated health data: study protocol for the PROStep randomised controlled trial

Ravi B Parikh, William Ferrell, Jonathan Wakim, Joelle Williamson, Neda Khan, Michael Kopinsky, Mohan Balachandran, Peter E Gabriel, Yichen Zhang, Lynn M Schuchter, Lawrence N Shulman, Jinbo Chen, Mitesh S Patel, Christopher R Manz, Ravi B Parikh, William Ferrell, Jonathan Wakim, Joelle Williamson, Neda Khan, Michael Kopinsky, Mohan Balachandran, Peter E Gabriel, Yichen Zhang, Lynn M Schuchter, Lawrence N Shulman, Jinbo Chen, Mitesh S Patel, Christopher R Manz

Abstract

Introduction: Patients with advanced cancers often face significant symptoms from their cancer and adverse effects from cancer-associated therapy. Patient-generated health data (PGHD) are routinely collected information about symptoms and activity levels that patients either directly report or passively record using devices such as wearable accelerometers. The objective of this study was to test the impact of an intervention integrating remote collection of PGHD with clinician and patient nudges to inform communication between patients with advanced cancer and their oncology team regarding symptom burden and functional status.

Methods and analysis: This single-centre prospective randomised controlled trial randomises patients with metastatic gastrointestinal or lung cancers into one of three arms: (A) usual care, (B) an intervention that integrates PGHD (including weekly text-based symptom surveys and passively recorded step counts) into a dashboard delivered to oncology clinicians at each visit and (C) the same intervention as arm B but with an additional text-based active choice intervention to patients to encourage discussing their symptoms with their oncology team. The study will enrol approximately 125 participants. The coprimary outcomes are patient perceptions of their oncology team's understanding of their symptoms and their functional status. Secondary outcomes are intervention utility and adherence.

Ethics and dissemination: This study has been approved by the institutional review board at the University of Pennsylvania. Study results will be disseminated using methods that describe the results in ways that key stakeholders can best understand and implement.

Trial registration numbers: NCT04616768 and 843 616.

Keywords: HEALTH SERVICES ADMINISTRATION & MANAGEMENT; ONCOLOGY; Protocols & guidelines.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Trial schema. W2H, Way to Health. CRC, Clinical Research Coordinator
Figure 2
Figure 2
PROStep dashboard. ED, emergency department. OEC, Oncology Evaluation Center. ECOG, Eastern Cooperative Oncology Group performance status
Figure 3
Figure 3
Intervention by patient arm. PRO, patient-reported outcome; W2H, Way to Health.

References

    1. Curtis EB, Krech R, Walsh TD. Common symptoms in patients with advanced cancer. J Palliat Care 1991;7:25–9. 10.1177/082585979100700205
    1. Walsh D, Donnelly S, Rybicki L. The symptoms of advanced cancer: relationship to age, gender, and performance status in 1,000 patients. Support Care Cancer 2000;8:175–9. 10.1007/s005200050281
    1. Donnelly S, Walsh D. The symptoms of advanced cancer. Semin Oncol 1995;22:67–72.
    1. Petrick JL, Reeve BB, Kucharska-Newton AM, et al. . Functional status declines among cancer survivors: trajectory and contributing factors. J Geriatr Oncol 2014;5:359–67. 10.1016/j.jgo.2014.06.002
    1. van Abbema D, van Vuuren A, van den Berkmortel F, et al. . Functional status decline in older patients with breast and colorectal cancer after cancer treatment: a prospective cohort study. J Geriatr Oncol 2017;8:176–84. 10.1016/j.jgo.2017.01.003
    1. Marschner N, Zacharias S, Lordick F, et al. . Association of disease progression with health-related quality of life among adults with breast, lung, pancreatic, and colorectal cancer. JAMA Netw Open 2020;3:e200643. 10.1001/jamanetworkopen.2020.0643
    1. Hoppe S, Rainfray M, Fonck M, et al. . Functional decline in older patients with cancer receiving first-line chemotherapy. J Clin Oncol 2013;31:3877–82. 10.1200/JCO.2012.47.7430
    1. Nipp RD, El-Jawahri A, Moran SM, et al. . The relationship between physical and psychological symptoms and health care utilization in hospitalized patients with advanced cancer. Cancer 2017;123:4720–7. 10.1002/cncr.30912
    1. Goldberg SL, Paramanathan D, Khoury R, et al. . A patient-reported outcome instrument to assess symptom burden and predict survival in patients with advanced cancer: flipping the paradigm to improve timing of palliative and end-of-life discussions and reduce unwanted health care costs. Oncologist 2019;24:76–85. 10.1634/theoncologist.2018-0238
    1. Morrison EJ, Novotny PJ, Sloan JA, et al. . Emotional problems, quality of life, and symptom burden in patients with lung cancer. Clin Lung Cancer 2017;18:497–503. 10.1016/j.cllc.2017.02.008
    1. Xiao C, Polomano R, Bruner DW. Comparison between patient-reported and clinician-observed symptoms in oncology. Cancer Nurs 2013;36:E1–16. 10.1097/NCC.0b013e318269040f
    1. Pinquart M, Duberstein PR. Depression and cancer mortality: a meta-analysis. Psychol Med 2010;40:1797–810. 10.1017/S0033291709992285
    1. Omran S, Mcmillan S. Symptom severity, anxiety, depression, self- efficacy andquality of life in patients with cancer. Asian Pac J Cancer Prev 2018;19:365–74. 10.22034/APJCP.2018.19.2.365
    1. Vogt J, Beyer F, Sistermanns J, et al. . Symptom burden and palliative care needs of patients with incurable cancer at diagnosis and during the disease course. Oncologist 2021;26:e1058–65. 10.1002/onco.13751
    1. Henson LA, Maddocks M, Evans C, et al. . Palliative care and the management of common distressing symptoms in advanced cancer: pain, breathlessness, nausea and vomiting, and fatigue. J Clin Oncol 2020;38:905–14. 10.1200/JCO.19.00470
    1. Jin JO. Performance status in patients with cancer. JAMA Oncol 2015;1:998. 10.1001/jamaoncol.2015.3113
    1. Laugsand EA, Sprangers MAG, Bjordal K, et al. . Health care providers underestimate symptom intensities of cancer patients: a multicenter European study. Health Qual Life Outcomes 2010;8:104. 10.1186/1477-7525-8-104
    1. Chandwani KD, Zhao F, Morrow GR, et al. . Lack of Patient-Clinician concordance in cancer patients: its relation with patient variables. J Pain Symptom Manage 2017;53:988–98. 10.1016/j.jpainsymman.2016.12.347
    1. Chidambaram S, DeShields T, Potter P, et al. . Patient and provider concordance on symptoms during the oncology outpatient clinic visit. J Community Support Oncol 2014;12:370–7. 10.12788/jcso.0080
    1. Abdolkhani R, Gray K, Borda A, et al. . Patient-generated health data management and quality challenges in remote patient monitoring. JAMIA Open 2019;2:471–8. 10.1093/jamiaopen/ooz036
    1. Wood WA, Bennett AV, Basch E. Emerging uses of patient generated health data in clinical research. Mol Oncol 2015;9:1018–24. 10.1016/j.molonc.2014.08.006
    1. Shaprio M, Johnston D, Wald J. Patient-generated health data. White paper. In: Prepared for office of policy and planning. RTI International, 2012.
    1. What are patient-generated health data? 2021. Available: [Accessed 04 May 2021].
    1. Basch E, Deal AM, Dueck AC, et al. . Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment. JAMA 2017;318:197–8. 10.1001/jama.2017.7156
    1. Bubis LD, Davis L, Mahar A, et al. . Symptom burden in the first year after cancer diagnosis: an analysis of patient-reported outcomes. J Clin Oncol 2018;36:1103–11. 10.1200/JCO.2017.76.0876
    1. Basch E, Barbera L, Kerrigan CL, et al. . Implementation of patient-reported outcomes in routine medical care. Am Soc Clin Oncol Educ Book 2018;38:122–34. 10.1200/EDBK_200383
    1. Absolom K, Warrington L, Hudson E, et al. . Phase III randomized controlled trial of eRAPID: eHealth intervention during chemotherapy. J Clin Oncol 2021;39:734–47. 10.1200/JCO.20.02015
    1. Kennedy F, Absolom K, Clayton B, et al. . Electronic patient reporting of adverse events and quality of life: a prospective feasibility study in general oncology. JCO Oncol Pract 2021;17:e386–96. 10.1200/OP.20.00118
    1. Benze G, Nauck F, Alt-Epping B, et al. . PROutine: a feasibility study assessing surveillance of electronic patient reported outcomes and adherence via smartphone APP in advanced cancer. Ann Palliat Med 2019;8:104–11. 10.21037/apm.2017.07.05
    1. Tian Y, Qiu X, Wang C, et al. . Cancer associates with risk and severe events of COVID-19: a systematic review and meta-analysis. Int J Cancer 2021;148:363–74. 10.1002/ijc.33213
    1. Kuderer NM, Lyman GH. Challenges of cancer immunotherapy during the COVID-19 pandemic. Cancer Invest 2021;39:115–9. 10.1080/07357907.2020.1864129
    1. Dai M, Liu D, Liu M, et al. . Patients with cancer appear more vulnerable to SARS-CoV-2: a multicenter study during the COVID-19 outbreak. Cancer Discov 2020;10:783–91. 10.1158/-20-0422
    1. Wood WA, Deal AM, Stover AM, et al. . Comparing Clinician-Assessed and patient-reported performance status for predicting morbidity and mortality in patients with advanced cancer receiving chemotherapy. JCO Oncol Pract 2021;17:e111–8. 10.1200/OP.20.00515
    1. Popovic G, Harhara T, Pope A, et al. . Patient-Reported functional status in outpatients with advanced cancer: correlation with Physician-Reported scores and survival. J Pain Symptom Manage 2018;55:1500–8. 10.1016/j.jpainsymman.2018.02.015
    1. Purswani JM, Ohri N, Champ C. Tracking steps in oncology: the time is now. Cancer Manag Res 2018;10:2439–47. 10.2147/CMAR.S148710
    1. Gresham G, Hendifar AE, Spiegel B, et al. . Wearable activity monitors to assess performance status and predict clinical outcomes in advanced cancer patients. NPJ Digit Med 2018;1:27. 10.1038/s41746-018-0032-6
    1. Pavic M, Klaas V, Theile G, et al. . Feasibility and usability aspects of continuous remote monitoring of health status in palliative cancer patients using Wearables. Oncology 2020;98:386–95. 10.1159/000501433
    1. Ormel HL, van der Schoot GGF, Westerink N-DL, et al. . Self-Monitoring physical activity with a smartphone application in cancer patients: a randomized feasibility study (SMART-trial). Support Care Cancer 2018;26:3915–23. 10.1007/s00520-018-4263-5
    1. Patel MS, Volpp KG, Asch DA. Nudge units to improve the delivery of health care. N Engl J Med 2018;378:214–6. 10.1056/NEJMp1712984
    1. Manz CR, Parikh RB, Small DS, et al. . Effect of integrating machine learning mortality estimates with behavioral Nudges to clinicians on serious illness conversations among patients with cancer: a Stepped-Wedge cluster randomized clinical trial. JAMA Oncol 2020;6:e204759. 10.1001/jamaoncol.2020.4759
    1. Takvorian SU, Ladage VP, Wileyto EP, et al. . Association of behavioral Nudges with high-value evidence-based prescribing in oncology. JAMA Oncol 2020;6:1104–6. 10.1001/jamaoncol.2020.0746
    1. Wang E, Major VJ, Adler N, et al. . Supporting acute advance care planning with precise, timely mortality risk predictions. NEJM Catalyst 2021;2. 10.1056/CAT.20.0655
    1. Hsiang EY, Mehta SJ, Small DS, et al. . Association of an active choice intervention in the electronic health record directed to medical assistants with clinician ordering and patient completion of breast and colorectal cancer screening tests. JAMA Netw Open 2019;2:e1915619. 10.1001/jamanetworkopen.2019.15619
    1. Mehta SJ, Feingold J, Vandertuyn M, et al. . Active choice and financial incentives to increase rates of screening Colonoscopy-A randomized controlled trial. Gastroenterology 2017;153:1227–9. 10.1053/j.gastro.2017.07.015
    1. Patel MS, Kurtzman GW, Kannan S, et al. . Effect of an automated patient Dashboard using active choice and peer comparison performance feedback to physicians on statin prescribing: the prescribe cluster randomized clinical trial. JAMA Netw Open 2018;1:e180818. 10.1001/jamanetworkopen.2018.0818
    1. Asch DA, Volpp KG. On the way to health. LDI Issue Brief 2012;17:1–4.
    1. Fortunato M, Harrison J, Oon AL, et al. . Remotely monitored Gamification and social incentives to improve glycemic control among adults with uncontrolled type 2 diabetes (iDiabetes): protocol for a randomized controlled trial. JMIR Res Protoc 2019;8:e14180. 10.2196/14180
    1. Patel MS, Asch DA, Rosin R, et al. . Framing financial incentives to increase physical activity among overweight and obese adults: a randomized, controlled trial. Ann Intern Med 2016;164:385–94. 10.7326/M15-1635
    1. Chokshi NP, Adusumalli S, Small DS, Small Dylan S, et al. . Loss-Framed financial incentives and personalized Goal-Setting to increase physical activity among ischemic heart disease patients using wearable devices: the active reward randomized trial. J Am Heart Assoc 2018;7:e009173. 10.1161/JAHA.118.009173
    1. Patel MS, Benjamin EJ, Volpp KG, et al. . Effect of a Game-Based intervention designed to enhance social incentives to increase physical activity among families: the be fit randomized clinical trial. JAMA Intern Med 2017;177:1586–93. 10.1001/jamainternmed.2017.3458
    1. Russell LB, Norton LA, Pagnotti D, et al. . Using clinical trial data to estimate the costs of behavioral interventions for potential Adopters: a guide for Trialists. Med Decis Making 2021;41:9–20. 10.1177/0272989X20973160
    1. National Cancer Institute . Common terminology criteria for adverse events (CTCAE). Available: [Accessed 04 May 2021].
    1. Cancer Care Ontario . Patient reported functional status (PRFS) tool. Available: [Accessed 04 May 2021].
    1. Case MA, Burwick HA, Volpp KG, et al. . Accuracy of smartphone applications and wearable devices for tracking physical activity data. JAMA 2015;313:625–6. 10.1001/jama.2014.17841
    1. Alinia P, Cain C, Fallahzadeh R, et al. . How accurate is your activity Tracker? A comparative study of step counts in low-intensity physical activities. JMIR Mhealth Uhealth 2017;5:e106. 10.2196/mhealth.6321
    1. Tedesco S, Sica M, Ancillao A, et al. . Validity evaluation of the Fitbit Charge2 and the Garmin vivosmart HR+ in free-living environments in an older adult cohort. JMIR Mhealth Uhealth 2019;7:e13084. 10.2196/13084
    1. American College of Physicians High Value Care Task Force . Communication about serious illness care goals: a review and synthesis of best practices. JAMA Intern Med 2014;174:1994–2003. 10.1001/jamainternmed.2014.5271

Source: PubMed

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

3
Subskrybuj