ACCEPTANCE: protocol for a feasibility study of a multicomponent physical activity intervention following treatment for cervical cancer

Abstract

IntroductionCervical cancer treatment can have life changing sequelae and be associated with poor short-term and long-term quality of life. Physical activity (PA; that is, bodily movement) is known to improve health outcomes and quality of life for cancer survivors, both physically and psychologically. To date, no interventions to increase PA following cervical cancer have been evaluated. This study aims to (1) determine the feasibility of conducting a PA intervention after cervical cancer and (2) to explore the acceptability of the programme and evaluation measures.Methods and analysisThe design is a pre study and post study design. Thirty participants aged between 18 and 60 years from the Midlands region, UK, who have completed primary treatment for cervical cancer at least 6 months previously and do not meet the national PA guidelines will be recruited. Identification of potential participants will take place through the University Hospitals of Leicester National Health Service (NHS) Trust. Participants will receive an intervention focused on increasing PA through the provision of education, action planning, goal setting, problem solving and self-monitoring of PA behaviour, particularly steps per day. Device assessed PA and questionnaires will be completed at baseline, week 6, week 12 and week 24. Feasibility will be assessed in terms of recruitment, retention, attrition, completion of measures and intervention compliance, for which specific feasibility criteria have been established. The process evaluation will explore the experiences and acceptability of the intervention components and evaluation measures.Ethics and disseminationEthical approval has been granted by the West of Scotland Research Ethics Committee 1 for this study. Results will inform intervention refinement for the design of a definitive pilot trial. These results will be disseminated via peer-reviewed publications and international conferences while input from a patient and public involvement (PPI) group will inform effective ways to circulate results among the wider community.Trial registration numberISRCTN16349793, Registered 30 September 2020.

The feasibility and acceptability of delivering and evaluating a physical activity intervention (ACCEPTANCE) for cervical cancer survivors

“…4. Contextual factors: Understanding the context in which the intervention was delivered Full details of the qualitative and quantitative process evaluation methods are published separately [34] and are available in the associated PhD thesis [48].…”

“…Feasibility thresholds were determined a priori in the study protocol using NIHR guidance. [34] Means and standard deviations (SDs) were used to describe PA and sleep metrics from the accelerometer at each evaluation time point (baseline = T0; week-6 = T1; week-12 = T2; week-24 = T3).Constructs measured via questionnaire were computed using standard scoring procedures. Change scores were calculated for each outcome for participants who provided data at each time point: T0 and T1; T1 and T2; T2 and T3; T0 and T3.…”

“…Details on the intervention development [4] and the study protocol including feasibility objectives [34] have been published previously. In brief, the aim of the multi-component intervention was to increase PA levels of the target population, speci cally through individual and group-based walking over 12 consecutive weeks.…”