Integrative supportive care trial to enhance physical activity in malignant pleural effusion—Protocol for the ISC-TEAM/AMPLE-5 randomised controlled trial

Abstract

Background: Malignant pleural effusion (MPE) heralds advanced cancer with poor patient outcomes. High symptom burden of weight loss, fatigue, breathlessness, distress, and anxiety leaves many patients unable to participate in desired activities of daily life and is associated with poor outcomes. Freedom from symptoms and maintaining daily activities are the key wishes of patients and carers. For the best outcome, accessible services aimed at prevention and management of malnutrition, care of psychological well-being, and support for increasing physical activity are required. Methods: The Integrative Supportive Care Trial to Enhance physical Activity in Malignant pleural effusion (ISC-TEAM) study is a two-armed, parallel group randomised controlled trial. Participants (n = 100) diagnosed with MPE will be randomly assigned to receive standard clinical care or integrative supportive care. Integrative supportive care will entail an individualised multidisciplinary program of dietetics, exercise physiology, and psychological input over 12 weeks. Participants will receive telehealth consultations with each discipline at week 1, week 4, and week 8. The primary outcome is device-assessed daily physical activity (steps/day). Secondary outcomes include quality of life, malnutrition risk, psychopathology, symptoms, physical activity profile, and program acceptability and compliance. Discussion: This randomised trial will evaluate the effects of a multidisciplinary supportive care program in MPE aimed at improving participants ability to engage in physical activities. Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN12624000038594; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=386529&isReview=true