Capturing Acute Toxicity Data During Lung Radiotherapy by Using a Patient-Reported Assessment Tool

doi:10.1016/j.cllc.2012.06.003

Clinical Lung Cancer

Volume 14, Issue 2, March 2013, Pages 108-112

https://doi.org/10.1016/j.cllc.2012.06.003 Get rights and content

Abstract

Background

Comprehensive and accurate assessment of symptoms experienced by patients undergoing lung radiotherapy (RT) is challenging. This study aims to evaluate the feasibility and utility of collecting acute toxicity information by using a patient-reported instrument, the Thoracic Symptom Self-Assessment Tool (TSSAT).

Methods

The TSSAT is based on the CTCAE v3.0(Common Toxicity Criteria of Adverse Events). All patients undergoing lung RT at our center from May 2008 to April 2009 were asked to complete the TSSAT on day 1 and weekly during RT. TSSAT scores were compared with clinician reporting of the same symptoms. Descriptive statistics and weighted kappa values were calculated to measure the agreement between patient- and clinician-reported acute toxicity.

Results

Of 300 consecutive patients approached, 49% (148/300) completed the TSSAT at least once. Patient participation and compliance were associated with treatment intent; radical (87%) vs. palliative (25%); P = <.0001. The average data completion rate by patients was 72%, and the average toxicity documentation rate by clinicians was 67%. Agreement between patients and clinicians was fair to moderate for most symptoms; the majority (>79%) of the differences were within one grade. Patients reported greater severity than clinicians for subjective symptoms. Clinicians graded greater severity than patients for the more observable symptoms.

Conclusions

The TSSAT has been shown to be feasible and accepted by patients receiving radical dose RT. Patient-reported assessments may improve acute symptom management in the future.

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.

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Cited by (6)

Feasibility and Pilot Studies in Palliative Care Research: A Systematic Review
2017, Journal of Pain and Symptom Management
Citation 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).
Feasibility and pilot study designs are common in palliative care research. Finding standard guidelines on the structure and reporting of these study types is difficult.
In feasibility and pilot studies in palliative care research, to determine 1) how commonly a priori feasibility are criteria reported and whether results are subsequently reported against these criteria? and 2) how commonly are participants' views on acceptability of burden of the study protocol assessed?
Four databases (OVID Medline, EMBASE, CINAHL, and PubMed via caresearch.com.au.) were searched. Search terms included palliative care, terminal care, advance care planning, hospice, pilot, feasibility, with a publication date between January 1, 2012 and December 31, 2013. Articles were selected and appraised by two independent reviewers.
Fifty-six feasibility and/or pilot studies were included in this review. Only three studies had clear a priori criteria to measure success. Sixteen studies reported participant acceptability or burden with measures. Forty-eight studies concluded feasibility.
The terms “feasibility” and “pilot” are used synonymously in palliative care research when describing studies that test for feasibility. Few studies in palliative care research outline clear criteria for success. The assessment of participant acceptability and burden is uncommon. A gold standard for feasibility study design in palliative care research that includes both clear criteria for success and testing of the study protocol for participant acceptability and burden is needed. Such a standard would assist with consistency in the design, conduct and reporting of feasibility and pilot studies.
Investigation of a Patient Reported Outcome tool to assess radiotherapy-related toxicity prospectively in patients with lung cancer
2014, Radiotherapy and Oncology
Citation 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.
There is a paucity of data regarding the feasibility and relevance of Patient Reported Outcome (PRO) tools to assess radiotherapy-related toxicity in lung cancer.
From January to June 2013, lung cancer patients undergoing thoracic radiotherapy/chemo-radiotherapy completed nine patient-adapted Common Terminology Criteria for Adverse Events (CTCAE), the European Organisation for Research and Treatment of Cancer Quality of Life (QoL) questionnaire and the Hospital Anxiety and Depression Scale (HADS) at baseline, the end of radiotherapy and at follow-up. Clinicians completed the same CTCAE items and agreement between patients’ and clinicians’ reporting was assessed using weighted kappa coefficients. QoL and HADS scores were correlated with the patients’ and clinicians’ reported toxicity.
70/116 patients completed the questionnaires for at least one time point excluding baseline. Agreement between patients’ and clinicians’ reported toxicity ranged from slight to substantial. Most discrepancies were within one grade and patients reported greater severity than clinicians for most symptoms. QoL and HADS scores were more strongly correlated with the patients’ compared to clinicians’ matching toxicity reports. The PRO tool was found to be statistically reliable.
The use of a PRO tool in lung cancer radiotherapy is feasible, reliable and acceptable to patients. PROs should be integrated in future clinical trials evaluating new radiotherapy approaches to assess toxicity.
An Empirical Comparative Assessment of Inter-Rater Agreement of Binary Outcomes and Multiple Raters
2022, Symmetry
Implementing a method for evaluating patient-reported outcomes associated with oral oncolytic therapy
2017, Journal of Oncology Practice
The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review
2016, Supportive Care in Cancer
Cognitive interviewing of the US national cancer institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE)
2014, Quality of Life Research

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Original studyCapturing Acute Toxicity Data During Lung Radiotherapy by Using a Patient-Reported Assessment Tool

Abstract

Background

Methods

Results

Conclusions

Introduction

Section snippets

Materials and Methods

Statistical Analysis

Results

TSSAT Feasibility and Utility

Disclosure

Radiother Oncol

Int J Radiat Oncol Biol Phys

Urol Oncol

Int J Radiat Oncol Biol Phys

Int J Radiat Oncol Biol Phys

Int J Radiat Oncol Biol Phys

Lancet Oncol

Semin Radiat Oncol

Eur J Cancer

Radiother Oncol

Original study
Capturing Acute Toxicity Data During Lung Radiotherapy by Using a Patient-Reported Assessment Tool