Nessa Millet, Hilary J McDermott, Fehmidah Munir, Charlotte L Edwardson, Tatiana Plekhanova, Esther L Moss
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引用次数: 0
Abstract
Background: Cervical cancer treatment can be associated with long-term physical, psychological and emotional issues leading to compromised quality of life (QOL). Physical activity (PA) may improve QOL in cervical cancer survivors.
Methods: A one-arm pre/post-feasibility study with parallel process evaluation was conducted to test the feasibility and acceptability of a 12-week PA intervention (ACCEPTANCE). Feasibility was determined by using pre-established criteria relating to inclusion criteria, recruitment and retention, compliance with intervention components and compliance with evaluation measures. The 12-week intervention consisted of (1) an online education session on the benefits of PA and a barrier identification and problem-solving session; (2) a Fitbit monitor; (3) daily and weekly diary entries; (4) brief fortnightly online health coaching sessions; and (5) organising and participating in group walks; (6) online social interaction via a messaging group. Measures included accelerometer assessed PA and sleep, quality-of-life and PA behaviour change questionnaires distributed at 4-time points (baseline, week 6, week 12, and week 24). Process evaluation measures were questionnaires on the acceptance of intervention components and semi-structured interviews with participants after completion.
Results: Thirty participants were recruited with a retention rate of 77% at week 24. The education session, health coaching and Fitbit PA monitor were deemed to be feasible based on compliance rates whilst the online messaging group, diary and group walking compliance suggested that modifications would be needed for these components. Accelerometer and questionnaires were deemed to be feasible evaluation measures based on compliance rates. Process evaluation results suggest that the Fitbit and health coaching sessions were perceived to be the most beneficial aspects of the programme as they enabled self-monitoring of behaviour and goal setting. Unexpected mechanisms of behaviour change were the integration of a small change approach and formation of habits to facilitate PA, whilst barriers to behaviour change included the online, virtual nature of the programme, poor mental health, and environmental challenges. PA levels were higher after the intervention, whilst global QOL was seen to worsen throughout the study, and depression and anxiety symptoms improved.
Conclusions: The ACCEPTANCE study is deemed to be feasible based on criteria established a priori, and only minor modifications would needed to implement in a definitive randomised control trial. The intervention showed potential to increase PA, through hypothesised mechanisms of self-monitoring behaviour and problem solving and unexpected mechanisms such as habit formation.
Trial registration: ISRCTN16349793, Registered 30 September 2020.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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