Boosting REcovery and Activity THrough Early WELLness (BREATHE WELL), A Prehabilitation program for Lung and Esophageal Cancer: A Study Protocol for a Nonrandomized Trial (Preprint)
Authors: Langley Jodi E , Sibley Daniel , Chiekwe Joy , Keats Melanie R , Snow Stephanie , Purcell Judith , Sollows Stephen , Hill Leslie , Watton David , Gaudry Abbigael , Hashish Ibrahim , Wallace Alison 
Published: May 2024

BACKGROUND

Cancer is the leading cause of death in Canada, responsible for 28.2% of all deaths. Based on surgical candidacy and disease status both lung and esophageal cancer are treated through surgical resection by a thoracic surgeon. Although surgery contributes to improved outcomes, patients experience risk of 30-day post-operative mortality as high as 10% and 2.8% respectively. Evidence has shown that prehabilitation is a way in which patients can have improved post-operative outcomes. Prehabilitation is multimodal, often including some form of movement, nutrition, stress management, and smoking cessation. Given the complexity of the healthcare system, pragmatic trials are important methodological tools to assess internal validity and improve current practice under real world conditions. Concurrently, using community resources is imperative to keep people active in their community and create sustainable programming.

OBJECTIVE

The objective of Boosting REcovery and Activity THrough Early WELLness (BREATHE WELL) is to explore the feasibility, implementation, and preliminary effectiveness of a clinically integrated, community-based prehabilitation health coaching program, including nutrition, smoking cessation, sleep hygiene and movement for individuals scheduled to undergo surgery for lung or esophageal cancer.

METHODS

This is a pilot, non-randomized, pragmatic, repeated measures, mixed methods trial. We will recruit 32 participants diagnosed with lung or esophageal cancer and are scheduled to undergo surgical resection into the prehabilitation program. Participants who agree will then go through an 8-week tailored prehabilitation program (in-person or online) covering movement, nutrition, stress management, nutrition, goal setting and smoking cessation. They will complete 6 sessions prior to surgery and then have 4 session, 1x/ week following surgery. Following the completion of the program, they will have 3 boosters session via phone or Zoom. The primary outcomes is feasibility i) recruitment feasibility: recruitment rate (# of participants referred per month), enrollment rate (# of enrolled participants / # of referred participants), reasons for declining, prehabilitation window (time between consent and surgery) and ii) intervention feasibility: adherence to the movement intervention, attrition, safety, study completion rate, and adverse events). Secondary outcomes include measures of preliminary effectiveness including patient reported outcomes including well-being as measured by the Functional Assessment of Cancer Therapy – Lung OR Esophageal and fatigue (Functional Assessment of Chronic Illness Therapy – Fatigue) and functional measures (stair climb, grip strength, 5x chair stand). All measures will be assessed pre, mid- and post prehabilitation program.

RESULTS

This study has been funded by Dalhousie University, Department of Surgery. The protocol was approved by Nova Scotia Health Research Ethics Board (REB# 1030020). Enrollment is anticipated to begin in September 2024.

CONCLUSIONS

This study will inform feasibility, implementation, and preliminary effectiveness of a clinically integrated community-based prehabilitation program in Nova Scotia, Canada for people scheduled to undergo curative intent surgery for lung and esophageal cancer.

CLINICALTRIAL

NCT06354959