Original studyCapturing Acute Toxicity Data During Lung Radiotherapy by Using a Patient-Reported Assessment Tool
Introduction
Patient-reported outcomes (PRO), namely treatment toxicity and symptoms experienced, are more comprehensive and accurate than clinician-reported assessments.1, 2 PROs are commonly used in health-related quality-of-life and symptom research but not in monitoring toxicity experienced by patients undergoing radiotherapy (RT).3, 4, 5, 6, 7 The Quantitative Analysis of Normal Tissue Effects in the Clinic Group has highlighted the importance of reporting and recording toxicity.8 At present, RT toxicity information is collected most often in clinical trials or research protocols and less formally in clinical practice. When it is collected, this information involves clinicians obtaining, interpreting, and documenting patient symptoms. This form of toxicity data collection can be challenging due to clinician time constraints, lack of patient empowerment to report toxicity, and communication barriers between patients and clinicians. Furthermore, results of research have shown low concordance among patient and clinician rating of symptoms,5, 9, 10, 11 especially when reporting subjective symptoms such as fatigue and dyspnea.12, 13 These factors contribute to under-reporting of treatment-related toxicity and potentially suboptimal management of patients' symptoms.
The National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) is the recommended standard for the collection and documentation of toxicity information in cancer treatment trials.14 Several groups have successfully adapted salient CTCAE items into language suitable for patients undergoing RT to the head and neck or to the pelvis, and chemotherapy for lung cancers.12, 15, 16 These tools have demonstrated high levels of patient use and satisfaction, and clinician acceptance. However, to date, a patient-based toxicity reporting tool based on CTCAE has not been developed to assess treatment-related adverse effects in patients undergoing lung RT. In this study, we evaluated the feasibility, utility, and agreement between patients and clinicians reporting of toxicity events by using a Thoracic Symptom Self-Assessment Tool (TSSAT) developed at our center.
Section snippets
Materials and Methods
The TSSAT was developed by selecting and adapting lung cancer–specific items from the CTCAE v3.0 into language suitable for English speaking patients. Items selected were fatigue, insomnia, cough, hemoptysis, dyspnea, chest pain, dysphagia, odynophagia, voice changes, skin changes, nausea, and vomiting. These items were reviewed and agreed upon by health care professionals (radiation oncologists, radiation therapists, and nurses) of the lung-site group at our center. Instructions specified the
Statistical Analysis
Standard descriptive statistics summarized the participating patient characteristics and identified factors associated with patient compliance. Rates of compliance were compared by using the χ2 test. The average data completion rate by patients was calculated by tabulating the total number of completed TSSATs and by dividing that number by the total number of weeks of RT treatment for each patient. Because it was not usual practice at our center for clinicians to work with a checklist of
Results
From May 2008 to April 2009, 300 patients received thoracic RT at our center. Of the 49% (148/300) who agreed to participate, the majority were treated with a radical intent (n = 103). Patient participation and compliance differed by treatment intent. Rates of patients who completed the TSSAT at least once were 87% (103/119) for patients receiving radical intent RT and 25% (45/181) for patients who received palliative intent RT (P < .0001).
Of the 103 patients treated with radical intent, 26
TSSAT Feasibility and Utility
This study evaluated the feasibility and utility of the TSSAT in assessing acute toxicity in the RT treatment environment. In general, we have observed a good level of patient use and acceptance, although few patients completed the TSSAT every week throughout the course of treatment. Possible reasons for the low patient compliance include treatment intent, and TSSAT design-related issues. These are discussed below.
Disclosure
The authors have stated that they have no conflicts of interest.
References (20)
- et al.
The early toxicity of escalated versus standard dose conformal radiotherapy with neo-adjuvant androgen suppression for patients with localised prostate cancer: results from the MRC RT01 trial (ISRCTN47772397)
Radiother Oncol
(2007) - et al.
Four-week course of radiation for breast cancer using hypofractionated intensity modulated radiation therapy with an incorporated boost
Int J Radiat Oncol Biol Phys
(2007) - et al.
Patient-reported acute gastrointestinal toxicity in men receiving 3-dimensional conformal radiation therapy for prostate cancer with or without neoadjuvant androgen suppression therapy
Urol Oncol
(2005) - et al.
Quantitative analyses of normal tissue effects in the clinic (QUANTEC): an introduction to the scientific issues
Int J Radiat Oncol Biol Phys
(2010) - et al.
Grading xerostomia by physicians or by patients after intensity-modulated radiotherapy of head-and-neck cancer
Int J Radiat Oncol Biol Phys
(2006) - et al.
Clinically meaningful differences in patient-reported outcomes with amifostine in combination with chemoradiation for locally advanced non-small-cell lung cancer: an analysis of RTOG 9801
Int J Radiat Oncol Biol Phys
(2008) - et al.
Patient versus clinician symptom reporting using the National Cancer Institute common terminology criteria for adverse events: results of a questionnaire-based study
Lancet Oncol
(2006) - et al.
CTCAE 3.0: development of a comprehensive grading system for the adverse effects of cancer treatment
Semin Radiat Oncol
(2003) - et al.
Developing a CTCAEs patient questionnaire for late toxicity after head and neck radiotherapy
Eur J Cancer
(2009) - et al.
Inter-professional variability in the assignment and recording of acute toxicity grade using the RTOG system during prostate radiotherapy
Radiother Oncol
(2009)
Cited by (6)
Feasibility and Pilot Studies in Palliative Care Research: A Systematic Review
2017, Journal of Pain and Symptom ManagementCitation Excerpt :Four of these 25 studies were designated as pilot studies, but did not report feasibility objectives.19,21–22,39 Although the remaining 22 studies did not explicitly state they were of a pilot or feasibility study design, feasibility was a key feature of the objectives of these studies.18,53–73 Twenty-three of the 56 studies provided statements about feasibility measures (Table 4).
Investigation of a Patient Reported Outcome tool to assess radiotherapy-related toxicity prospectively in patients with lung cancer
2014, Radiotherapy and OncologyCitation Excerpt :Possible reasons for these discrepancies include time constraints in clinics, the subjective nature of the symptoms, clinicians’ tendency to underestimate the severity of toxicities, patients’ reluctance to disclose personal information, clinicians’ hesitancy to discuss these issues due to (perceived) lack of training and communication barriers between patients and clinicians [17,18]. To our knowledge, this is the second study (following the recent study from the Toronto Group [13]) and the first study in Europe to assess patients’ and clinicians’ agreement and evaluate the feasibility and effectiveness of a PRO tool in lung cancer patients receiving radiotherapy. The Toronto Group showed that the TSSAT, a PRO tool assessing acute radiotherapy toxicity was feasible and acceptable to patients.
Implementing a method for evaluating patient-reported outcomes associated with oral oncolytic therapy
2017, Journal of Oncology Practice