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Background
Head and neck cancer (HNC) and its treatment with concurrent chemo-radiotherapy (CRT) have a profound negative impact on physical functioning, body composition, fatigue and quality of life (QoL).
Studies in other cancer populations have shown the benefits of physical exercise on these side effects of cancer treatment. HNC patients may also benefit from exercising during treatment, but studies in this population are scarce.
Due to the high symptom load associated with CRT, engaging in exercise programmes is challenging for these patients. Therefore, a feasibility study is needed to assess uptake, adherence, tolerability and participant satisfaction of such a programme during CRT.
Hypothesis and objectives
We hypothesise that, ultimately, an exercise intervention will have beneficial effects on fitness, body composition, fatigue, treatment tolerability and QoL. Therefore, we here propose a feasibility study in order to design an optimal, large-scale RCT for testing our hypothesis.
Primary objective (feasibility)
- To determine adherence to and compliance with the exercise intervention.
- To explore patients’ satisfaction with the exercise intervention.
- To determine recruitment and retention rates.
Secondary objectives
- To obtain preliminary data for power calculations for a future RCT.
- To compare changes in physical performance and muscle strength, body composition, fatigue, QoL, and CRT tolerability in our sample to those reported in the literature for this population.
Settings and methods
Design
A 2-centre pre-post study using a mixed methods design. Quantitative measures will be obtained on intervention feasibility, physical function and self-reported health outcomes, and qualitative methods (interviews) will be used to gain insight into the participants’ perspective on feasibility, satisfaction and intervention improvements.
Population
Thirty-seven HNC patients scheduled for CRT.
Intervention
The 10-week intervention (duration of CRT+3 weeks) consists of 30 minutes of moderate-intensity aerobic activity (six days/week), and resistance exercises for three days/week. At least one exercise session/week is supervised, further home-based. The intervention is adapted to individual capacity, and behavioural support is offered during the supervised exercise sessions. Nutritional support will be provided as part of usual care.
Outcomes
Feasibility outcomes are adherence to and compliance with the exercise programme, recruitment and retention in the study. The experiences of study participants with the intervention will be explored in semi-structured interviews. Preliminary outcome data on physical fitness, body composition, fatigue, QoL and CRT tolerability will be obtained at baseline and 12-week post-baseline.
Statistical analysis
Quantitative results will be presented descriptively with percentages, means and standard deviations. Changes in physical fitness, body composition, fatigue and QoL data are estimated as medians with 95% confidence intervals obtained by bootstrapping. Semi-structured interviews will be analysed using thematic descriptive analyses and the software package NVivo.
Impact
The outcomes of this feasibility study will have an impact on the design of an RCT, comparing the exercise intervention to usual care during CRT as developed, tested and optimized here. If demonstrated to be effective in a future RCT, the intervention can be implemented in usual care and should improve health outcomes for this population.
Grant publication
Kok A, Passchier E, May AM, Jager-Wittenaar H, Veenhof C, de Bree R, Stuiver MM, Speksnijder CM. Expectations and Experiences of Participating in a Supervised and Home-Based Physical Exercise Intervention in Patients with Head and Neck Cancer during Chemoradiotherapy: A Qualitative Study. Current Oncology. 2024; 31(2):885-899.