Protocol for the CHEST Australia Trial: a phase II randomised controlled trial of an intervention to reduce time-to-consult with symptoms of lung cancer

Abstract

IntroductionLung cancer is the most common cancer worldwide, with 1.3 million new cases diagnosed every year. It has one of the lowest survival outcomes of any cancer because over two-thirds of patients are diagnosed when curative treatment is not possible. International research has focused on screening and community interventions to promote earlier presentation to a healthcare provider to improve early lung cancer detection. This paper describes the protocol for a phase II, multisite, randomised controlled trial, for patients at increased risk of lung cancer in the primary care setting, to facilitate early presentation with symptoms of lung cancer.Methods/analysisThe intervention is based on a previous Scottish CHEST Trial that comprised of a primary-care nurse consultation to discuss and implement a self-help manual, followed by self-monitoring reminders to improve symptom appraisal and encourage help-seeking in patients at increased risk of lung cancer. We aim to recruit 550 patients from two Australian states: Western Australia and Victoria. Patients will be randomised to the Intervention (a health consultation involving a self-help manual, monthly prompts and spirometry) or Control (spirometry followed by usual care). Eligible participants are long-term smokers with at least 20 pack years, aged 55 and over, including ex-smokers if their cessation date was less than 15 years ago. The primary outcome is consultation rate for respiratory symptoms.Ethics and disseminationEthical approval has been obtained from The University of Western Australia's Human Research Ethics Committee (RA/4/1/6018) and The University of Melbourne Human Research Committee (1 441 433). A summary of the results will be disseminated to participants and we plan to publish the main trial outcomes in a single paper. Further publications are anticipated after further data analysis. Findings will be presented at national and international conferences from late 2016.Trial registration numberAustralian New Zealand Clinical Trial Registry ACTRN 1261300039 3752.

Lung cancer symptom appraisal among people with chronic obstructive pulmonary disease: A qualitative interview study

“…Our study provides insights into how to intervene at different levels of influence to improve the likelihood of patients and health care professionals suspecting and acting on potential lung cancer. Studies testing health care–based interventions addressing symptom awareness/normalisation and fatalism in patients at high risk of lung cancer are ongoing . Our study highlights the potential need for similar interventions in patients with COPD, and we have developed recommendations in order to help mitigate specific issues within this sample (see Box ).…”

“…Studies testing health care-based interventions addressing symptom awareness/normalisation and fatalism in patients at high risk of lung cancer are ongoing. 27,28 Our study highlights the potential need for similar interventions in patients with COPD, and we have developed recommendations in order to help mitigate specific issues within this sample (see Box 1). For example, raising the awareness of the link between cancer and COPD in patients will help in identifying symptoms as something different, but this needs to be dealt with sensitively to avoid increased fatalism.…”

Promoting Help-Seeking in Response to Symptoms amongst Primary Care Patients at High Risk of Lung Cancer: A Mixed Method Study

“…Recent studies have also indicated the potential effectiveness of targeted, local GP-based interventions, which combine symptom awareness, education, and strategies that reduce complexity in appointment scheduling specifically for patients at-risk of lung cancer[34,45,46]. A randomised controlled trial of one such intervention is currently underway in Australia[47]. …”

Improving early diagnosis of symptomatic cancer

“…promoting earlier presentation of potential cancer symptoms [3][4][5][6][7] ; the use of new technologies in the assessment of pigmented skin lesions 8 ; the use of computerized decision-support tools in the diagnosis of cancer in primary care 9 ; cancer-specific education for general practitioners (GPs) 5,10 ; direct access to low-dose CT for the early detection of lung cancer in primary care 11 ; and lower symptom thresholds for urgent use of chest radiography 12 . Thus far, no trial has included a sufficiently large cohort to address the issue of whether or not expedited cancer diagnosis in primary care is beneficial, in terms of either mortality or morbidity.…”