The feasibility of implementing an exercise programme for deconditioned cancer survivors in a national cancer centre: FIXCAS Study

Introduction

There are currently more than 150,000 cancer survivors in Ireland, and this number continues to rise (Department of Health, 2017). Furthermore, with advances in early detection and treatment of cancer in the context of an aging population, by 2020 1 in 2 Irish people will be a cancer survivor (Department of Health, 2017). Subsequently, as both the number of cancer survivors and the length of survival time are increasing, long-term health complications related to cancer treatment are becoming more prevalent (Miller et al., 2016; Rowland & Bellizzi, 2014).

Depending on treatment pathways, cancer survivors can face several negative consequences of cancer treatment that include psychological (depression or anxiety, fear of recurrence, cognitive impairment) and/or physical symptoms (pain, peripheral neuropathy, sexual dysfunction, gait and balance deficits, joint mobility issues and lymphoedema) (Beesley et al., 2007; Caraceni & Portenoy, 1999; Hendren et al., 2005; Massie, 2004; Mehnert et al., 2009; Mock et al., 2001; O'Dell & Stubblefield, 2009; Quasthoff & Hartung, 2002; Vardy et al., 2007). Numerous systematic reviews demonstrate that exercise can mitigate a number of these factors in cancer survivors and improve quality of life, fatigue, physical function and cardiorespiratory fitness and can optimise functional status, preserving the ability to remain in the workforce and fulfil other life roles (Courneya & Friedenreich, 1999; Galvão & Newton, 2005; McNeely et al., 2006).

Despite the robust body of existing literature, addressing the long-term side effects of cancer is a major challenge for health care policy and the integration and delivery of exercise rehabilitation and survivorship into standard clinical cancer care continues to remain the exception rather than the norm (Mulcahy et al., 2018). Internationally, models of cancer survivorship care have been developing rapidly in recent years, many centring on the provision of exercise rehabilitation programmes across diverse delivery settings (Oeffinger & McCabe, 2006). However, referral to exercise specialists is not a part of the standard care received by oncology patients in Ireland, with a distinct lack of rehabilitation services available for cancer survivors (Mulcahy et al., 2018).

The aim of the FIXCAS study is to examine the feasibility of implementing a 10-week multi-modal exercise rehabilitation programme to deconditioned cancer survivors in a National Cancer Centre. The implementation of the programme would be a large step towards the integration of exercise rehabilitation into survivorship services in Ireland.

Methods

Safety

All serious adverse events (SAE)/adverse events (AE) will be recorded on study specific adverse event forms. All AEs will be registered with the principle investigator (PI). These will be discussed at regular team meetings and collected and registered at the end of the study. In the case of an SAE, the PI will be informed at time of occurrence (with 24 h). The investigator can decide to withdraw a participant from the study for urgent medical reasons or safety concerns. Participants can leave the study at any time for any reason if they wish to do so without any consequences. Participants who withdraw from the study will be invited to attend assessment.

Data management

Data will be collected and recorded in a paper-based study case report form (extended data (Sheill, 2019)). The case report form will maximise the quality of the data captured and minimise the risk of erroneous data collection. Each case report form will be assigned the participant study identification code to ensure patient anonymity. Qualitative interviews will be recorded using a dictaphone and transcribed. Coded information will be stored on a secure, password protected, encrypted computer. The key to the participants code will be stored separately in a password protected file, on a secure, password protected, encrypted computer at the study site. All hard copies of study data, electronic interview transcripts and audio recordings will be retained and stored securely for 10 years at Trinity College Dublin.

The data repository will be maintained by designated members of the research team who will input data. Data will be only be accessible to authorised members of the research team. All authorised team members will receive training regarding the data management plan before authorisation is granted for data processing. In line with open access publication requirements, the anonymised final data set will be archived in a secure online data repository.

Statistical analysis

Data analysis will be performed using IBM SPSS Statistics version 24 (SPSS Inc, Chicago, IL). As this is a feasibility study, a sample size calculation was not performed. Summary statistics for continuous variables (means and standard deviations or medians and ranges as appropriate) and categorical variables (counts and proportions) will be presented. Graphical summaries will be used to compare the distributions of each response variable and for patient characteristics. A linear mixed model will be used to model the longitudinal change in the primary measures while adjusting for the response variable and for the within subject correlation in the repeated measures across time.

Ethics and dissemination

Ethics approval will be granted by St. James’s Hospital and Tallaght University Hospital Research Ethics Committee (approval pending). The study results will be used to optimise the intervention content and may serve as the foundation for a larger definitive trial. We aim to disseminate the results through peer-review journals, presentation at conferences and relevant clinical groups. The International Committee of Medical Journal Editors (ICJME) recommendations will be adhered to in all reporting of trial data.

Study status

The study is currently pending local Research and Ethics Committee approval and is not yet recruiting.

Discussion

The article describes the protocol of a feasibility study evaluating an individualised 10-week FIXCAS multi-modal exercise programme in deconditioned cancer survivors aiming to improve physical function and quality of life.

Research has demonstrated that cancer survivors experience physical deficits including low levels of physical activity, poor cardiorespiratory fitness (Gannon et al., 2017) and sarcopenia (Elliott et al., 2017). As physical fitness has been broadly linked to the quality of life of cancer survivors, fitness can be considered a modifiable factor that can subsequently impact positively on quality of life (Cheema & Gaul, 2006; Courneya et al., 2003; O’Neill et al., 2018).

Despite robust evidence supporting the role of exercise in cancer recovery, none of the eight cancer centres in Ireland provide exercise based survivorship programmes for cancer survivors and exercise rehabilitation is not an element of standard care for patients with cancer in Ireland (Mulcahy et al., 2018). High feasibility and acceptability of exercise interventions in a research setting has been demonstrated for oesophageal cancer survivors in Ireland. A 12 week supervised and home- based exercise and education sessions resulted in clinically significant improvements in functional performance and QoL (O’Neill et al., 2017). However, the feasibility of offering an exercise rehabilitation programme to a broad range of cancer survivor groups in the clinical setting of a national cancer centre requires further exploration.

The intervention consists of a 10 week (2 sessions weekly) individualised multi-modal exercise programme. The content of the intervention was modelled on national and cancer-specific recommendations of the American College of Sports Medicine and evidence from existing literature and guidelines (Schmitz et al., 2010). The American College of Sports Medicine (ACSM) has concluded that exercise both during and after cancer treatment is safe and should be encouraged, although prescriptions should be individualised according to the patient (Schmitz et al., 2010). Therefore, the FIXCAS programme will be tailored to each individual patient taking into consideration their current health status, physical activity levels, and individual post treatment impairments following the ACSM recommendations.

Important strengths of the intervention include the application of the programme in a real-world clinical practice setting. Secondly, we consider the timing of the intervention to be advantageous. Surveys of cancer survivors clearly show a preference for commencing an exercise program after primary treatments have been completed, with many studies indicating a preference for the 3–6-month period after completion of treatment (Broderick et al., 2013). This time period, termed the ‘recovery or rehabilitation period’, may be the optimal window for commencing an exercise program to reverse a downward trajectory in activity levels and fitness as well as addressing any lingering treatment-related side effects (Broderick et al., 2013).

Conclusion

In this article, we present the study design to investigate the feasibility of delivering a 10-week multi-modal exercise rehabilitation programme in a national cancer care centre. In addition, we outlined the protocol of an intervention aimed at improving physical fitness, quality of life and other health related outcomes in cancer survivors. The results of the feasibility study may be used for optimisation of the intervention content and may serve as a foundation for evaluating the intervention in a larger randomised controlled trial.

Ethics approval

St. James’s Hospital and Tallaght University Hospital Research and Ethics Committee (approval pending). Any protocol modifications will be communicated in writing to the Research and Ethics Committee and updated on the trial registration.

Data availability