Background and aim
The evaluation of patient-reported outcomes (PRO) in cancer has proven relevant positive clinical impact on patients’ communication with healthcare professionals, decision-making for management, well-being, and overall survival. However, the optimal frequency of PRO assessment has yet to be defined. Based on the assumption that more frequent sampling would enhance accuracy, we aimed at identifying the optimal sampling frequency that does not miss clinically relevant insight.
We used pilot data from 31 advanced cancer patients who completed once daily the 19-item MD Anderson Symptom Inventory at home. The resulting dataset allowed us to compare different PRO assessment frequencies to daily sampling, i.e., alternate days (q2d), every third day (q3d), or once a week (q1w). We evaluated the sampling frequencies for two main outcomes: average symptom intensity and identification of severe symptoms.
The majority of the differences between corresponding averages of daily data and those for q2d, q3d, and q1w datasets were close to 0, yet the extremes exceeded 5. Clinically meaningful differences, i.e., > 1, were observed in 0.76% of patient items for q2d, in 2.72% for q3d, and in 11.93% for q1w. Moreover, median values of missed instances of a severe symptom (i.e., > 6) were 14.6% for q2d, 27.8% for q3d, and 55.6% for q1w.
Our analysis suggests that in patients receiving chemotherapy for advanced cancer, increasing the density of PRO collection enhances the accuracy of PRO assessment to a clinically meaningful extent. This is valid for both computations of averages symptom burden and for the recognition of episodes of severe symptom intensity.
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The data that support the findings of this study are available from the corresponding author, PFI, upon reasonable request.
Absolom K, Warrington L, Hudson E, Hewison J, Morris C, Holch P, Carter R, Gibson A, Holmes M, Clayton B, Rogers Z, McParland L, Conner M, Glidewell L, Woroncow B, Dawkins B, Dickinson S, Hulme C, Brown J, Velikova G (2021) Phase III randomized controlled trial of eRAPID: eHealth Intervention During Chemotherapy. J Clin Oncol 39(7):734–747. https://doi.org/10.1200/JCO.20.02015
Basch E, Deal AM, Dueck AC, Scher HI, Kris MG, Hudis C, Schrag D (2017) Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment. JAMA 318:197–198
Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D (2016) Symptom monitoring with patient-reported outcomes during routine cancer treatment: a randomized controlled trial. J Clin Oncol 34:557–565
Basch E, Stover AM, Schrag D, Chung A, Jansen J, Henson S, Carr P, Ginos B, Deal A, Spears PA, Jonsson M, Bennett AV, Mody G, Thanarajasingam G, Rogak LJ, Reeve BB, Snyder C, Kottschade LA, Charlot M, Weiss A, Bruner D, Dueck AC (2020) Clinical utility and user perceptions of a digital system for electronic patient-reported symptom monitoring during routine cancer care: findings from the PRO-TECT trial. JCO Clin Cancer Inform 4:947–957
Bouchahda M, Komarzynski S, Ulusakarya A, Attari A, Duprès A, Breda G, Fritsch A, Adam R, Levi F (2020) Improving FOLFIRINOX safety in pancreatic cancer patients through multidimensional remote monitoring and proactive care using a domomedecine mobile platform. J Clin Oncol 38: TPS4673-TPS4673
Ciani O, Cucciniello M, Petracca F, Apolone G, Merlini G, Novello S, Pedrazzoli P, Zilembo N, Broglia C, Capelletto E, Garassino M, Nicod E, Tarricone R (2019) Lung Cancer App (LuCApp) study protocol: a randomised controlled trial to evaluate a mobile supportive care app for patients with metastatic lung cancer. BMJ Open 9:e025483
Cleeland CS, Mendoza TR, Wang XS, Chou C, Harle MT, Morrissey M, Engstrom MC (2000) Assessing symptom distress in cancer patients: the M.D. Anderson Symptom Inventory Cancer 89:1634–1646
Coens C, Pe M, Dueck AC, Sloan J, Basch E, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Devlin N, Dorme L, Flechtner HH, Gotay C, Griebsch I, Groenvold M, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro JZ, O’Connor D, Oliver K, Piault-Louis E, Piccart M, Quinten C, Reijneveld JC, Schurmann C, Smith AW, Soltys KM, Taphoorn MJB, Velikova G, Bottomley A, Setting International Standards in Analyzing Patient-Reported O, Quality of Life Endpoints Data C (2020) International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the SISAQOL Consortium. Lancet Oncol 21: e83-e96
Crafoord MT, Fjell M, Sundberg K, Nilsson M, Langius-Eklof A (2020) Engagement in an interactive app for symptom self-management during treatment in patients with breast or prostate cancer: mixed methods study. J Med Internet Res 22:e17058
Giesinger JM, Blazeby J, Aaronson NK, Sprangers M, Fayers P, Sparano F, Rees J, Anota A, Wan C, Pezold M, Isharwal S, Cottone F, Efficace F, Group EQoL (2020) Differences in patient-reported outcomes that are most frequently detected in randomized controlled trials in patients with solid tumors: a pooled analysis of 229 trials. Value Health 23: 666-673
Greer JA, Jacobs JM, Pensak N, Nisotel LE, Fishbein JN, MacDonald JJ, Ream ME, Walsh EA, Buzaglo J, Muzikansky A, Lennes IT, Safren SA, Pirl WF, Temel JS (2020) Randomized trial of a smartphone mobile app to improve symptoms and adherence to oral therapy for cancer. J Natl Compr Canc Netw 18:133–141
Innominato PF, Komarzynski S, Mohammad-Djafari A, Arbaud A, Ulusakarya A, Bouchahda M, Haydar M, Bossevot-Desmaris R, Plessis V, Mocquery M, Bouchoucha D, Afshar M, Beau J, Karaboue A, Morere JF, Fursse J, Rovira Simon J, Levi F (2016) Clinical relevance of the first domomedicine platform securing multidrug chronotherapy delivery in metastatic cancer patients at home: the inCASA European Project. J Med Internet Res 18:e305
Jones HV, Smith H, Cooksley T, Jones P, Woolley T, Gwyn Murdoch D, Thomas D, Foster B, Wakefield V, Innominato P, Mullard A, Ghosal N, Subbe C (2020) Checklists for complications during systemic cancer treatment shared by patients, friends, and health care professionals: prospective interventional cohort study. JMIR Mhealth Uhealth 8:e19225
Karamanidou C, Natsiavas P, Koumakis L, Marias K, Schera F, Schafer M, Payne S, Maramis C (2020) Electronic patient-reported outcome-based interventions for palliative cancer care: a systematic and mapping review. JCO Clin Cancer Inform 4:647–656
Komarzynski S, Huang Q, Levi FA, Palesh OG, Ulusakarya A, Bouchahda M, Haydar M, Wreglesworth NI, Morere JF, Adam R, Innominato PF (2019) The day after: correlates of patient-reported outcomes with actigraphy-assessed sleep in cancer patients at home (inCASA project) Sleep 42
Low CA, Dey AK, Ferreira D, Kamarck T, Sun W, Bae S, Doryab A (2017) Estimation of symptom severity during chemotherapy from passively sensed data: exploratory study. J Med Internet Res 19:e420
Mouillet G, Falcoz A, Fritzsch J, Almotlak H, Jacoulet P, Pivot X, Villanueva C, Mansi L, Kim S, Curtit E, Meneveau N, Adotevi O, Jary M, Eberst G, Vienot A, Calcagno F, Pozet A, Djoumakh O, Borg C, Westeel V, Anota A, Paget-Bailly S (2021) Feasibility of health-related quality of life (HRQoL) assessment for cancer patients using electronic patient-reported outcome (ePRO) in daily clinical practice. Qual Life Res. https://doi.org/10.1007/s11136-020-02721-0
Osborn J, Ajakaiye A, Cooksley T, Subbe CP (2020) Do mHealth applications improve clinical outcomes of patients with cancer? A critical appraisal of the peer-reviewed literature. Support Care Cancer 28:1469–1479
Osoba D, Rodrigues G, Myles J, Zee B, Pater J (1998) Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol 16:139–144
Wang XS, Zhao F, Fisch MJ, O’Mara AM, Cella D, Mendoza TR, Cleeland CS (2014) Prevalence and characteristics of moderate to severe fatigue: a multicenter study in cancer patients and survivors. Cancer 120:425–432
We are sincerely grateful to the patients who participated in the inCASA pilot, to the other oncologists who enrolled the patients under their care, to the nurses involved in data collection, and to the members of the inCASA European project. The clinical dataset used was collected within a pilot study from a research project supported by the European Union through the Seventh Framework Programme.
No specific ethical approval was necessary for this study. The patient-generated dataset was part of a pilot study (inCASA: Integrated Network for Completely Assisted Senior Citizen’s Autonomy), which was approved by the local institutional review board (Villejuif, France).
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Innominato, P.F., Komarzynski, S., Dallmann, R. et al. Impact of assessment frequency of patient-reported outcomes: an observational study using an eHealth platform in cancer patients. Support Care Cancer (2021). https://doi.org/10.1007/s00520-021-06262-1
- Patient-reported outcomes
- Digital oncology