This is a pilot, nonrandomized, pragmatic, repeated measures, mixed methods trial to assess the feasibility, implementation, and effectiveness of a clinically integrated, community-based, multimodal prehabilitation program for patients with lung and esophageal cancers in an urban academic health center in Halifax, Nova Scotia, Canada. Participant flow throughout the study is presented in Figure 1. This study aligns with the TREND (Transparent Reporting of Evaluations of Nonrandomized Design) checklist (Multimedia Appendix 1) for nonrandomized trials [19].

Based on a monthly surgical volume of 10 patients per month to the referring surgeon, assuming an enrollment rate of 25% while accounting for 20% attrition within a 16-month recruitment window, we will seek to recruit 64 participants (aged 18 years and older) diagnosed with lung or esophageal cancer (32 in the program and 32 who decline). This is based on the number of surgical candidates that the current surgeon sees in a 2-year period. Participants will be identified based on the following inclusion criteria: (1) confirmed diagnosis of lung or esophageal cancer; (2) treatment plan includes surgery (at least 2 weeks from the time of consent) [20]; (3) fluent in English; and (4) surgical oncologist approval. Exclusion criteria include (1) unstable or symptomatic cardiac disease, musculoskeletal injury, or comorbid disease that precludes the ability to safely engage in physical activity or (2) significant cognitive limitations.

Feasibility (primary outcome) will include (1) recruitment feasibility—recruitment rate (the number of participants referred per month), enrollment rate (the number of enrolled participants divided by the number of referred participants), reasons for declining, and prehabilitation window (time between consent and surgery); and (2) intervention feasibility (adherence to the movement intervention, attrition, safety, study completion rate, and adverse events). The feasibility target for recruitment is a 25% enrollment rate. The feasibility target for adherence is 70% or more, measured by attendance to movement sessions with the qualified exercise professional. The feasibility target for attrition is 20% or less [22]. A timeline of feasibility measures is available in Table 3.

Participant outcome measures will include demographic information (age, sex, gender, socioeconomic status, race, marital status, educational level, and health knowledge), anthropometric measurements (height, weight, and BMI), medical information (surgery type, diagnosis, date of diagnosis, treatment status, and other chronic conditions), and patient-reported outcomes (PROs) that include quality of life (Functional Assessment of Cancer Therapy–Lung or Functional Assessment of Cancer Therapy–Esophageal) [23,24] and fatigue (Functional Assessment of Chronic Illness Therapy–Fatigue) [25]. Both the Functional Assessment of Cancer Therapy–Lung or Functional Assessment of Cancer Therapy–Esophageal and Functional Assessment of Chronic Illness Therapy–Fatigue have been extensively validated and are reliable and widely used tools in the oncology setting [23]. Participants will have the option of completing surveys using the web-based (REDCap [Research Electronic Data Capture]; Vanderbilt University) database or using a pen and paper–based survey. A comprehensive assessment of functionality will be conducted in person in the clinic by the surgeon. Functional assessments are based on the Canadian Society of Exercise Physiology’s Physical Activity Training for Health Protocol and include height, weight, resting heart rate and blood pressure, 5× chair sit-stand, stair climbing test, and grip strength. As part of standard of care, participants will undergo pulmonary function tests; these measures include tidal volume, forced vital capacity, vital capacity, and functional residual capacity.

The participants will be interviewed prior to the commencement of the program to better understand their perception of prehabilitation health coaching and to better understand their history with movement and healthy lifestyle behaviors. This will include questions that are based on past behaviors and future goals. This interview will be audio recorded and transcribed verbatim. A content analysis will be done using the Behavior Change Wheel and Theoretical Domains Frameworks [26,27]. This will aid in better understanding the behavior and barriers or facilitators to engage in the behavior. For sustained behavior change, participants need to have the Capability, Opportunity, and Motivation to perform the behavior [27]. Participants will also be interviewed at the end of the program to better understand their satisfaction with the program. This will also aid in understanding participants’ perceptions of where they are regarding long-term behavior change. Postprogram interviews will be conducted to better understand their perspective on the program and how or if they found the program beneficial; these interviews will probe the understanding of sustained health behavior change and program satisfaction.

Postoperative outcomes include length of hospital stay and postoperative complications. The severity of complications will be graded according to the Clavien-Dindo classification [28,29]. Return to the emergency department within 90 days after the operation and 90-day mortality will also be assessed.

The statistical analysis for this trial will be conducted with R (R Foundation for Statistical Computing). Participant characteristics will be summarized using descriptive statistics (mean, SD, frequency, and percentage). We will report on reasons for exclusion, attrition, and adverse events with frequency and percentages for each group. Safety will be determined by examining the total number of adverse events that occur over the duration of the program. Adherence to movement sessions will be summarized as a percentage (the number of movement sessions attended divided by the number of available movement sessions).

Baseline demographic and disease-related variables will be compared between prehabilitation and data-only participants using 1-way ANOVA for continuous variables and a chi-square test for categorical variables. The effectiveness analysis will include a linear mixed model to assess the difference in physical fitness and PROs from baseline (T0) to the preoperative (T1), postoperative (T2), 4-6 weeks postoperative (T3), and 32-week long-term follow-up (PROs only) time points, where the time point is the fixed effect and the individual participant is the random effect. A sensitivity analysis will be performed adjusting for sex, surgical type, and age. Linear mixed effect models will also be used to determine between-group differences. An α of .05 will be considered statistically significant. Point estimates and 95% CIs will be calculated for changes in the physical function and PROs at each timepoint and will also be used to provide important information for future sample size calculations. A Poisson regression will be used to estimate differences between groups for postoperative outcomes (ie, length of hospital stays, postoperative complications, return to emergency department, and mortality). Missing outcome data will be imputed using multiple imputation effects. Conclusions will be drawn using comparisons of each time point relative to the baseline.

Qualitative description is used to describe rather than interpret phenomena. Content analysis, the process of making sense of the meaning in the data will also be used during our thematic analysis. The research assistant will work with an experienced qualitative researcher to conduct multiple reviews of the transcripts and tapes (step 1) to familiarize themselves with the data. The analysis will be initiated as soon as the first interview is completed and continued concurrently with data collection. The analysis will examine what individual, structural, cultural, and institutional contexts are hypothesized to affect success. Additional codes will emerge to develop a thematic framework (step 2) that reflects the language and experiences of participants. An audit trial will be used to document the decision-making process. Sections of the transcripts will be charted into themes (step 3). Codes will be combined into themes during a series of research team meetings in which the relationships between behavior and the patient’s capability, opportunity, and motivation to do said behavior will be explored and summarized. Analysts will review the codes and associate themes multiple times to check for potential biases, to ensure they reflect participants’ words, and to improve and validate the interpretation (step 4) of the interviews. Additional interviews may be added when new themes emerge. Initial findings will be shared with a group of participants to help with interpretation and generate meaning from the data.

This prehabilitation study includes human participants and was ethically approved by the Nova Scotia Health Research Ethics Board (REB# 1030020) in April 2024. All participants will go through a written informed consent procedure and will be aware that this study is completely confidential and voluntary. Participants will be given a small amount of money to offset the price of gas and parking when participating in an in-person program.

This study brings together a multidisciplinary team with extensive expertise in research and clinical practice within the field of exercise oncology (JEL, DS, JC, and MRK); exercise measurement, evaluation, and prescription (JEL, DS, JC, and MRK); medical oncology (SS and AW); thoracic surgery (AW); policy implementation (LH and JP); and care experience (SS). The study team has a history of collaboration and has brought in key knowledge users to assist with the implementation of this project after the completion of research funding.

The current standard of care for patients undergoing surgery does not include prehabilitation, although multiple randomized controlled trials have shown the efficacy of these programs [9,10,20,30]. Evidence is growing for the use of prehabilitation in standard of care, yet its implementation in clinical settings is still limited. BREATHE WELL will inform clinicians and knowledge users how structured prehabilitation programming using community settings and resources can bridge the gap between health care and the community. To maximize care pathways, it is imperative that those suited for community programs are triaged accordingly. Further, it is important to ensure that community-based resources are well equipped and trained to work with patients in prehabilitation to allow for sustained health behavior change and safe movement programming. Individuals living with and beyond cancer during and after treatment benefit from engaging in movement; however, they often lack the knowledge, resources, and guidance on how to do so safely and effectively [31-35]. By using an “exercise and educate” model focused on MI and health coaching, the emphasis will be on empowering participants to see the long-term benefits of behavior change and increase overall well-being for individuals. Also, previous community-based physical activity interventions with individuals living with and beyond cancer do see a longer-term increase in physical activity [11]. This could be due to familiarity with the environment and having increased support upfront, which can lead to better physical activity adherence. This study builds on previous evidence that prehabilitation is efficacious, yet its uptake into the standard of care is still lacking [14].

As part of this study, the intentional engagement of knowledge users including key health system partners, clinical care programs, and patients as team members will ensure high-quality evidence. It also provides an excellent infrastructure for rapid dissemination of findings into policy, practice, and clinical care. Knowledge translation initiatives will be ongoing throughout this research, including integrated and end-of-grant knowledge translation. We will regularly engage with all research team members, which includes key knowledge users (JP and LH) and patient partners (SS). The preliminary findings will be shared, when necessary, at team meetings, and interim research summary reports will be circulated via email and existing webinars and continuing education infrastructure established through our team members and collaborators. To support the further development of this project, we will generate an end-of-study summary report of key findings to policy and clinical partners. Findings will be disseminated to lung and esophageal cancer–specific audiences in Canada and internationally through conferences (eg, Canadian Association of Thoracic Surgeons Annual Meeting, American Association of Thoracic Surgeons Annual Meeting, Canada Cancer Research Alliance Annual Meeting, Canadian Society for Exercise Physiology Annual Meeting, and American Society of Clinical Oncology) and will be published in open access journals (eg, BMC Health Services Research) to enhance accessibility and potential for global reach and impact. This research will also be disseminated to patients and lay audiences through infographics to increase accessibility to a wider nonacademic audience.

There are several strengths to this study: (1) a pragmatic design allows for a deeper understanding of implementation and feasibility, which will aid in further understanding of prehabilitation in real-world settings; (2) the use of community-based facilities allows for a strong likelihood of not only system-level sustainability but also greater confidence for individuals to adhere to physical activity upon completion of the prehabilitation program; and (3) the use of a standard-of-care comparator group allows for preliminary effect estimates to understand if prehabilitation improves quality of care. However, this study is not without limitations. First, we have limited our sample to patients who have undergone thoracic surgery, which may not be generalizable to other populations with cancer. Second, the prehabilitation window is short (2-3 weeks), which precludes physiological changes. This is due to constraints from the diagnosis to the surgery date; if participants do have a longer window, they will be offered a longer presurgical program. However, with continued support after the surgery, participants will be supported to create long-term positive lifestyle changes and habits. Finally, this is a nonrandomized trial, which may decrease internal validity. However, the focus of this study is pragmatic in nature and the primary outcome is feasibility.

Prehabilitation is a key health intervention for those undergoing cancer surgery, with growing efficacy in the literature, yet the implementation of prehabilitation in real-world settings is lacking. BREATHE WELL will contribute to implementation science regarding approaches to support prehabilitation for surgical patients in a sustainable way that leverages the strengths of the health care and community setting.