Digital Health, Health Information Technology, Mobile Health, Oncology, Patient-Reported Outcomes, Remote Patient Monitoring
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Collaborative Reporting Solutions for Symptom and Treatment Side-Effects Monitoring in Colorectal Cancer

Kailesh Gopalbhai
Digital Health Innovation and Strategy Partner

1.  Patient-Reported Outcomes in Colorectal Cancer 

In recent years, there has been a significant improvement in overall survival with chemotherapies and targeted therapies in diverse cancers, especially colorectal cancer (1). Surgery followed by adjuvant or palliative chemotherapy is the standard of care of localized or advanced stages of colorectal cancer (CRC). It is widely recognized that the use of chemotherapy results in side-effects that adversely affect patients’ quality of life (QoL) (2). Depending on the chemotherapy regimen, diarrhea has rates 16-30%, neutropenia 8-29% and peripheral neuropathy 16-18%. As these conditions range from unpleasant to life-threatening, continuous monitoring of and contact with these patients is essential. Patient-reported outcomes are particularly important to understanding the trade-offs between treatment toxicity and survival benefit, especially when cure is not anticipated. Clinical decisions, for example, a treatment change (e.g., reduction of chemotherapy dose for fatigue), beginning a supportive therapy (e.g., providing an antiemetic for nausea), triaging for additional medical services (e.g., psychosocial care), or additional evaluation of a complaint (e.g., imaging a patient with abdominal pain postoperatively) may be made on the basis of patient-reported data.

Remote Cancer Patient Monitoring

Direct collection of patient-reported outcomes (PROs) represents an alternative paradigm. Tracking PROs provides advantages over clinician-reported outcomes by facilitating patient-clinician communication, providing new symptoms information and increasing efficiency and accuracy by eliminating the need for research study personnel to abstract symptoms from the medical record posthoc (3). PRO reports and alerts presented to clinicians must be clear and provide actionable data; however, it can be difficult to identify the appropriate thresholds for PRO-based clinical alerts (4). Many PRO questionnaires were designed to identify group estimates rather than individual change, and the clinical significance of particular scores is not always known. For these PRO questionnaires, the thresholds for alerts may require some adjustment over time based on the experience of clinical team that follow up on alerts and discuss scores with patients. Furthermore, as the use of PROs in clinical care increases, more PRO questionnaires will be developed or revised to better assess individual change.

Inclusion of patient-reported outcomes in oncology settings and care has been promoted by federal agencies, clinicians, and investigators (5). Patient-reported outcomes (PROs), such as symptom scales or more broad-based health-related quality-of-life measures, play an important role in cancer treatment evaluation, as well as for supportive and palliative oncology care. PROs must be relevant to patients and clinicians, valid, and easily understood and interpreted. PRO questionnaires consider patients’ perspective on symptoms (e.g., nausea, fatigue, diarrhea, pain), physical functioning (e.g., difficulty climbing stairs or difficulty fastening buttons), and mental health (e.g., anxiety, fear or depression). Many questionnaires enable CRC patients to rate their symptoms related to their quality of life (QoL) such as “the European Organization for Research and Treatment of Cancer (EORTC) QoL QLQ-C30 (6), validated in all European languages, the colorectal module QLQ-CR38 (7), and the Functional Assessment of Cancer Therapy-General version FACT-G named FACT-C (7) when specific concerns of patients with CRC are added to common items to all cancer patients”(8).

2. Review of Existing Strategies

Most people receive their cancer treatments on an outpatient basis and manage their side effects of the disease and treatments while at home. Yet, side-effects information from patients in clinical practice is either elicited from them at visits as part of a health review with the medical team or when they call between visits with particularly troublesome health problems. These approaches are inefficient and may not adequately identify symptoms for optimal or timely side-effect management.

Diverse approaches are taken for side-effects management including patient education with pre-chemotherapy discussion, information leaflets, patient-held diaries and targeted use of the internet. For cancer patients, the telephone is the fastest and most important way for access to cancer services (9). Therefore, remote access to health professionals by telephone or email is an important supportive service for patient assistance in cancer care and triaging symptoms to the right level of care. Clinicians will hold or reduce chemotherapy dose on the basis of patient-reported symptoms. Nurses will intervene between visits when they obtain information about patient self-reported symptoms (10); this lowers the probability that a patient will arrive for a visit with severe symptoms. Despite widespread availability of clinical practice guidelines for symptom management (11), they are in developed and not widely used for remote support (10).

3. mHealth Symptom Monitoring Solutions

Patient self-reporting of symptoms in the clinic waiting room or between visits via electronic interfaces has been shown to be feasible and efficient, to increase patient satisfaction with care, to be valued by clinicians as supporting documentation and to support clinical decisions, and to improve symptom management as well as patients’ overall quality of life (3, 12, 13). Various media are available for the collection of PROs, including traditional paper-based approaches (3), or electronic methods such as desktop/touch-screen computers (14) and telephone systems (9). Telephone follow-up for monitoring, supporting and providing healthcare advice has been successfully utilized for many years (15), but tends to be non-targeted and therefore time consuming.

Mobile phone systems, however, allow patients to monitor their health and automatically alert the healthcare team if dangerous symptoms develop (16). Timely detection of such symptoms and serious physiological parameters is critical to prevent deterioration in patients’ health. Therefore, many interventions use data captured with mobile phones to look for such indicators and to alert appropriate healthcare providers. As a growing number of tablet computers and mobile phones become Web-enabled, the prospect grows for real-time symptom reporting via these devices. Examples of electronic symptom assessment are presented to reflect the range of currently available functions and approaches. The systems vary in their goals and scope. This review of systems and their features is not meant to be exhaustive, but rather illustrative.

3.1 Advanced Symptom Management System during Chemotherapy

Patients can report their symptoms using PRO questionnaires built into a phone application. For example, the Advanced Symptom Management System (ASyMS) is a symptom monitoring system originally developed in the United Kingdom to track patient-reported symptoms and treatment toxicities during the course of chemotherapy in patients with lung, breast or colorectal cancer (17, 18). The system uses phone-based questionnaires to evaluate six side-effects indicators: nausea, vomiting, mucositis, hand-foot symptom, diarrhea and fatigue. Patients complete the symptom survey on their mobile telephone twice a day and any time they feel unwell. Patients’ responses are uploaded to a server and alerts based on the degree of severity (“amber alert” or “red alert”) are automatically generated and sent to the patient’s healthcare team. Nurses are able to review patients’ symptom scores through a secure Web page and then provide follow-up care and advice to patients. After completing the survey, patients also receive evidence-based self-care advice on their mobile telephone, which is tailored to their survey responses. Studies of this system have reported positive perceptions and experiences by nurses and patients (17, 18).

ASyMS has also been adapted for palliative care symptom management and youth populations (19, 20). The ASyMS was adapted for young people being treated with chemotherapy in order to measure their most common symptoms and concerns (i.e., mouth sores, nausea, vomiting, weight loss, and diarrhea), and to encourage children to find help for their symptoms instead of just tolerating them (21).

3.2 Mobile Phone-based System for Symptom Management during Chemotherapy

In colorectal cancer, a similar mobile phone symptom-monitoring strategy has been adapted to register the side-effects of chemotherapy and provide advice on management of toxicity (22). In a pilot study, CRC patients receiving adjuvant chemotherapy, entered symptom data onto user friendly screens on a mobile phone twice daily. Patient-reported data on nausea, vomiting, mucositis, diarrhoea and hand–foot syndrome and measurement of temperature was sent from different locations into a common central database. This pilot study demonstrated that the mobile phone-based system for monitoring patients’ symptoms worked well; patients had no problems entering symptom data on to the mobile phone and the data were transferred automatically to the remote server. Age was not an obstacle to use in this small sample. The research nurses were able to respond correctly to all the mobile phone toxicity alerts generated, either amber and red alerts, except one within the time scales set out in the protocol. Most importantly, patients felt secure in the knowledge that their symptoms were being closely monitored and that they were participating more successfully in their own care management.

3.3 Tele-ISAAC: Interactive Voice Recognition

Cancer Care Ontario is piloting Tele-ISAAC to allow patients to enter their symptom scores by telephone. Tele-ISAAC, an extension of the ISAAC web application, was initiated to permit cancer patients or his/her caregiver, without internet access, to enter their Edmonton Symptom Assessment System symptom scores, which addresses nine common symptoms including pain, nausea and anxiety, by telephone through an interactive voice recognition (IVR) system. In addition to Canada, the United Kingdom, the United States, and other countries have used the ESAS in oncology settings (23). As Tele-ISAAC is a data entry vehicle only, no new data elements are being collected and it does not have search or data retrieval capabilities.

4. New Collaborative Reporting Solutions: Enhanced Clinical Accuracy and Patient Safety

Abundant research has demonstrated that patient and clinician symptom reporting—and specially symptomatic side-effects during cancer treatment—presents different yet complementary information (24–26). Both the patient and clinician provide valuable information, which when combined provides a more accurate understanding of the patient’s symptoms. Indeed, Quinten et al. (27) reported that adding information gathered directly from study participants via PRO measures improves the predictive accuracy of clinician CTCAE reporting (e.g., raising the adjusted C-index from 0.63 to 0.67 for fatigue and from 0.62 to 0.65 for nausea, which represents a substantial improvement) (28). Bash et al. (26) also confirmed that while clinicians are capable to estimate survival correctly, patient reporting of symptomatic side-effects better represents the patient’s health and functional status. Therefore, availability of PRO data not only enhances the accuracy of clinician CTCAE reports but also may improve safety. In addition, the results strengthen support for the Patient Centered Outcomes Research Institute, which was recently authorized by Congress to develop, test and implement patient-reported outcome measures across the disciplines of medicine.

There are three potential approaches:

  1. Independent reporting where patient and clinician side-effects data are collected, analyzed and reported separately from each other;
  2. Combined reporting where patient and clinician data are collected separately and then analytically transformed into a composite metric; and
  3. Collaborative reporting in which patients directly report symptomatic side-effects data, which is then shared with clinicians to inform their CTCAE.

Of these three approaches, the collaborative reporting provides clinicians with important health-related outcome data about the patient experience instantly to inform not only their required clinical reporting but to support their ongoing management of side-effects. Furthermore, this approach leverages the doctor-patient relationship rather than relying on analytical calculation to merge their perspectives.

In lung cancer patients, Symptom Tracking and Reporting (STAR) System (12, 29), a collaborative reporting software platform, was used to collect 13 patient-reported symptomatic side-effects and patient-reported Karnofsky performance status (30). The essential features of STAR are a homepage at which users log in, online question items, a secure database, and an interface for generating longitudinal reports of previously entered data (12). At each visit, PRO questionnaires (26) were completed using a dedicated wireless laptop. This information was transmitted in real time to clinicians’ wireless computers. On the collaborative patient–clinician CTCAE reporting web interface, the clinicians were able to modify the treatment side-effects and disease-related symptoms reported by patients based on their own assessments, which remains the current approach to adverse event reporting. Clinicians agreed with patient-reported grades 92% of the time, raising severity 3% of the time and lowering it 5% of the time (31). This approach facilitates reporting of information closer to the time of events, and improves efficiency, and the ability to make earlier clinical decisions.

In oncology, a field in which symptoms are common and can significantly weaken patients’ functioning and quality of life, information about the patients’ experience of cancer treatment side-effects is important for multiple stakeholders, including patients, drug developers, regulators and payers:

  • Patients facing a treatment decision are interested to know cancer treatment side-effects based on the previous patient experiences with the same cancer indication.
  • Drug developers are interested in real-world evidence on how well patients tolerate a cancer therapy, particularly if the unmet medical need is based around patient-orientated factors such as tolerability or compliance rather than clinical efficacy driven.
  • Regulators know the limitations of symptomatic adverse event data reported by clinicians in trials. A systematic patient-reported approach would increase confidence in the reliability of this data toward balancing risks and benefits.
  • Payers are interested to understand patients’ performance and quality of life score with particular treatments as it enables to forecast the use of healthcare services.

In conclusion, patients are in the best position to report their subjective experiences, while clinicians are in the best position to contextualize that experience in terms of disease progression. Both provide a valuable perspective that can complementarily inform our understanding of cancer treatment side-effects.

5. References

  1. Gellad ZF and Provenzale D. 2010. Colorectal Cancer: National and international perspective on the burden of disease and public health impact.Gastroenterology138(6): 2177–2190.
  2. Siegel R, DeSantis C, Virgo K, Stein K, Mariotto A, Smith T, Cooper D, et al. 2012. Cancer treatment and survivorship statistics, 2012.CA. Cancer J. Clin.62(4): 220–241.
  3. Velikova G, Booth L, Smith AB, Brown PM, Lynch P, Brown JM, and Selby PJ. 2004. Measuring Quality of Life in Routine Oncology Practice Improves Communication and Patient Well-Being: A Randomized Controlled Trial.J. Clin. Oncol.22(4): 714–724.
  4. Basch E, Abernethy AP, Mullins CD, Reeve BB, Smith ML, Coons SJ, Sloan J, et al. 2012. Recommendations for Incorporating Patient-Reported Outcomes Into Clinical Comparative Effectiveness Research in Adult Oncology.J. Clin. Oncol. 30(34): 4249–4255.
  5. Trotti A, Colevas AD, Setser A, and Basch E. 2007. Patient-Reported Outcomes and the Evolution of Adverse Event Reporting in Oncology.J. Clin. Oncol.25(32): 5121–5127.
  6. Färkkilä N, Sintonen H, Saarto T, Järvinen H, Hänninen J, Taari K, and Roine RP. 2013. Health-related quality of life in colorectal cancer.Colorectal Dis.15(5): e215–e222.
  7. Rotonda C, Conroy T, Mercier M, Bonnetain F, Uwer L, Miny J, Montcuquet P, et al. 2008. Validation of the French version of the colorectal-specific quality-of-life questionnaires EORTC QLQ-CR38 and FACT-C.Qual. Life Res. 17(3): 437–445.
  8. Uwer L, Rotonda C, Guillemin F, Miny J, Kaminsky M-C, Mercier M, Tournier-Rangeard L, et al. 2011. Responsiveness of EORTC QLQ-C30, QLQ-CR38 and FACT-C quality of life questionnaires in patients with colorectal cancer.Health Qual. Life Outcomes9(1):70.
  9. Mooney KH, Beck SL, Friedman RH, and Farzanfar R. 2002. Telephone-Linked Care for Cancer Symptom Monitoring.Cancer Pract.10(3): 147–154.
  10. Macartney G, Stacey D, Carley M, and Harrison MB. 2012. Priorities, barriers and facilitators for remote support of cancer symptoms: a survey of Canadian oncology nurses.Can. Oncol. Nurs. J. Rev. Can. Nurs. Oncol.22(4): 235–247.
  11. Stacey D, Bakker D, Ballantyne B, Chapman K, Cumminger J, Green E, Harrison M, et al. 2012. Managing symptoms during cancer treatments: evaluating the implementation of evidence-informed remote support protocols.Implement. Sci.7(1): 110.
  12. Basch E, Artz D, Dulko D, Scher K, Sabbatini P, Hensley M, Mitra N, Speakman J, McCabe M, and Schrag D. 2005. Patient Online Self-Reporting of Toxicity Symptoms During Chemotherapy.J. Clin. Oncol.23(15): 3552–3561.
  13. Basch E, Iasonos A, Barz A, Culkin A, Kris MG, Artz D, Fearn P, et al. 2007. Long-Term Toxicity Monitoring via Electronic Patient-Reported Outcomes in Patients Receiving Chemotherapy.J. Clin. Oncol.25(34): 5374–5380.
  14. Wright EP, Selby PJ, Crawford M, Gillibrand A, Johnston C, Perren TJ, Rush R, et al. 2003. Feasibility and Compliance of Automated Measurement of Quality of Life in Oncology Practice.J. Clin. Oncol.21(2): 374–382.
  15. Mistiaen P and Poot E. 1996. Telephone follow-up, initiated by a hospital-based health professional, for postdischarge problems in patients discharged from hospital to home. InCochrane Database of Systematic Reviews. John Wiley & Sons, Ltd.
  16. Krishna S, Boren SA, and Balas EA. 2009. Healthcare via cell phones: a systematic review.Telemed. J. E-Heal. Off. J. Am. Telemed. Assoc.15(3): 231–240.
  17. McCann L, Maguire R, Miller M, and Kearney N. 2009. Patients’ perceptions and experiences of using a mobile phone-based advanced symptom management system (ASyMS©) to monitor and manage chemotherapy related toxicity.Eur. J. Cancer Care (Engl.)18(2): 156–164.
  18. Maguire R, McCann L, Miller M, and Kearney N. 2008. Nurse’s perceptions and experiences of using of a mobile-phone-based Advanced Symptom Management System (ASyMS©) to monitor and manage chemotherapy-related toxicity.Eur. J. Oncol. Nurs.12(4): 380–386.
  19. Gibson F, Aldiss S, Taylor RM, Maguire R, McCann L, Sage M, and Kearney N. 2010. Utilization of the Medical Research Council evaluation framework in the development of technology for symptom management: the ASyMS-YG Study.Cancer Nurs.33(5): 343–352.
  20. McCall K, Keen J, Farrer K, Maguire R, McCann L, Johnston B, McGill M, Sage M, and Kearney N. 2008. Perceptions of the use of a remote monitoring system in patients receiving palliative care at home.Int. J. Palliat. Nurs.14(9): 426–431.
  21. Gibson F, Aldiss S, Taylor RM, Maguire R, and Kearney N. 2009. Involving health professionals in the development of an advanced symptom management system for young people: The ASyMS©-YG study.Eur. J. Oncol. Nurs.13(3): 187–192.
  22. Weaver A, Young AM, Rowntree J, Townsend N, Pearson S, Smith J, Gibson O, Cobern W, Larsen M, and Tarassenko L. 2007. Application of mobile phone technology for managing chemotherapy-associated side-effects.Ann. Oncol.18(11): 1887–1892.
  23. Richardson LA and Jones GW. 2009. A review of the reliability and validity of the Edmonton Symptom Assessment System.Curr. Oncol.16(1): 55.
  24. Fromme EK, Eilers KM, Mori M, Hsieh Y-C, and Beer TM. 2004. How Accurate Is Clinician Reporting of Chemotherapy Adverse Effects? A Comparison With Patient-Reported Symptoms From the Quality-of-Life Questionnaire C30.J. Clin. Oncol.22(17): 3485–3490.
  25. Petersen MA, Larsen H, Pedersen L, Sonne N, and Groenvold M. 2006. Assessing health-related quality of life in palliative care: Comparing patient and physician assessments.Eur. J. Cancer42(8): 1159–1166.
  26. Basch E, Jia X, Heller G, Barz A, Sit L, Fruscione M, Appawu M, et al. 2009. Adverse Symptom Event Reporting by Patients vs Clinicians: Relationships With Clinical Outcomes.J. Natl. Cancer Inst.101(23): 1624–1632.
  27. Quinten C, Maringwa J, Gotay CC, Martinelli F, Coens C, Reeve BB, Flechtner H, et al. 2011. Patient Self-Reports of Symptoms and Clinician Ratings as Predictors of Overall Cancer Survival.J. Natl. Cancer Inst.103(24): 1851–1858.
  28. Ware JH. 2006. The Limitations of Risk Factors as Prognostic Tools.N. Engl. J. Med.355(25): 2615–2617.
  29. Basch E, Artz D, Iasonos A, Speakman J, Shannon K, Lin K, Pun C, et al. 2007. Evaluation of an Online Platform for Cancer Patient Self-reporting of Chemotherapy Toxicities.J. Am. Med. Inform. Assoc.14(3): 264–268.
  30. Pietanza MC, Basch EM, Lash A, Schwartz LH, Ginsberg MS, Zhao B, Shouery M, et al. 2013. Harnessing Technology to Improve Clinical Trials: Study of Real-Time Informatics to Collect Data, Toxicities, Image Response Assessments, and Patient-Reported Outcomes in a Phase II Clinical Trial.J. Clin. Oncol.31(16): 2004–2009.
  31. Basch E, Bennett A, and Pietanza MC. 2011. Use of Patient-Reported Outcomes to Improve the Predictive Accuracy of Clinician-Reported Adverse Events. J. Natl. Cancer Inst. 103(24): 1808–1810.