ACTivity as medicine In Oncology for Head and Neck (ACTIOHN): Protocol for a feasibility study investigating a patient-centred approach to exercise for people with head and neck cancer

PLoS One. 2023 Aug 25;18(8):e0289911. doi: 10.1371/journal.pone.0289911. eCollection 2023.

Abstract

Background and aim: Attempts at personalisation of exercise programmes in head and neck cancer (HaNC) have been limited. The main aim of the present study is to investigate the feasibility and acceptability of introducing a remotely delivered, fully personalised, collaborative, and flexible approach to prescribing and delivering exercise programmes into the HaNC usual care pathway.

Methods: This is a single arm, feasibility study. Seventy patients diagnosed with HaNC will be recruited from two regional HaNC centres in the United Kingdom. Patients will undertake an 8-week exercise programme designed and delivered by cancer exercise specialists. The exercise programme will start any time between the time of diagnosis and up to 8 weeks after completing treatment, depending on patient preference. The content of the exercise programme will be primarily based on patient needs, preferences, and goals, but guided by current physical activity guidelines for people with cancer. The primary outcome measure is retention to the study. Secondary quantitative outcomes are uptake to the exercise programme, different measures of exercise adherence, pre- and post-intervention assessments of fatigue (Multidimensional Fatigue Symptom Inventory-Short Form), quality of life (SF-36), physical activity levels (International Physical Activity Questionnaire-Short Form), and various components of physical fitness. The outcomes of the nested qualitative study are acceptability and feasibility of the intervention evaluated via interviews with patients, health care professionals, and the cancer exercise specialists. Intervention and participant fidelity will be determined using checklists and scrutiny of each patient's logbook and the cancer exercise specialists' meeting notes. Analysis of quantitative data will be via standard summary statistics. Qualitative data will be analysed using thematic analysis.

Expected results: This feasibility study will inform the design and conduct of a future randomised controlled trial. Success will be defined according to a traffic light system for identifying the appropriateness of progression to a randomised controlled trial.

Trial registration: International Standard Randomised Controlled Trial Number registry (ISRCTN82505455).

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Exercise
  • Fatigue
  • Feasibility Studies
  • Head and Neck Neoplasms* / therapy
  • Humans
  • Quality of Life*
  • Randomized Controlled Trials as Topic

Grants and funding

This project is funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number NIHR 202773), which was awarded to authors AWM, ARL, SNR, RCB, VB, SL, MMN, RP, AGS, BY, and JMP. The funder played no role in the design of the study or the writing of this protocol paper. They will play no role in data collection, data analysis, the writing of the results papers, or in the dissemination of the study findings. Funder website: https://www.nihr.ac.uk/explore-nihr/funding-programmes/research-for-patient-benefit.htm.