Multimodal prehabilitation in patients with non-small cell lung cancer undergoing anatomical resection: protocol of a non-randomised feasibility study

Abstract

Background: The preoperative period can be used to enhance a patient's functional capacity with multimodal prehabilitation and consequently improve and fasten postoperative recovery. Especially, non-small cell lung cancer (NSCLC) surgical patients may benefit from this intervention, since the affected and resected organ is an essential part of the cardiorespiratory fitness. Drafting a prehabilitation programme is challenging, since many disciplines are involved, and time between diagnosis of NSCLC and surgery is limited. We designed a multimodal prehabilitation programme prior to NSCLC surgery and aimed to conduct a study to assess feasibility and indicative evidence of efficacy of this programme. Publication of this protocol may help other healthcare facilities to implement such a programme.

Methods: The multimodal prehabilitation programme consists of an exercise programme, nutritional support, psychological support, smoking cessation, patient empowerment and respiratory optimisation. In two Dutch teaching hospitals, 40 adult patients with proven or suspected NSCLC will be included. In a non-randomised fashion, 20 patients follow the multimodal prehabilitation programme, and 20 will be assessed in the control group, according to patient preference. Assessments will take place at four time points: baseline, the week before surgery, 6 weeks postoperatively and 3 months postoperatively. Feasibility and indicative evidence of efficacy of the prehabilitation programme will be assessed as primary outcomes.

Discussion: Since the time between diagnosis of NSCLC and surgery is limited, it is a challenge to implement a prehabilitation programme. This study will assess whether this is feasible, and evidence of efficacy can be found. The non-randomised fashion of the study might result in a selection and confounding bias. However, the control group may help putting the results of the prehabilitation group in perspective. By publishing this protocol, we aim to facilitate others to evaluate and implement a multimodal prehabilitation programme for surgical NSCLC patients.

Trial registration: The current study is registered as NL8080 in the Netherlands Trial Register on the 10th of October 2019, https://www.trialregister.nl/trial/8080 . Secondary identifiers: CCMO (Central Committee on Research Involving Human Subjects) number NL70578.015.19, reference number of the Medical Ethical Review Committee of Máxima MC W19.045.

Keywords: Anatomical resection; Enhanced recovery after thoracic surgery; Feasibility; Functional capacity; Lung surgery; Non-small cell lung cancer; Physical conditioning; Postoperative outcome; Prehabilitation; Preoperative intervention.

Fig. 1

SPIRIT-derived overview of time points, assessments and recorded variables. 6MWT, 6-min walk test; BIA, bio-impedance electrical analysis; BMI, body mass index; EORTC QLQ-LC13, European Organisation for Research and Treatment of Cancer, quality of life of cancer patients — lung cancer-specific module; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer, quality of life of cancer patients module; EQ-5D-5L, general health-related quality of life questionnaire; HADS, Hospital Anxiety and Depression Scale; iMCQ, Institute for Medical Technology Assessment (iMTA) Medical Consumption Questionnaire; Indirect 1-RM strength test, indirect 1-repetition maximum; iPCQ, iMTA Productivity Cost Questionnaire; ISI, Insomnia Severity Index; MIP, maximal inspiratory pressure; PG-SGA, Patient-Generated Subjective Global Assessment; SRT, steep ramp test. *All questionnaires will be sent by e-mail