Participants will take part in a 12 week intervention, with at least one follow up at 24 +/- 2 weeks. Each participant will be provided with support, motivation and professional guidance about improving physical activity (PA) levels and will be given a commercially available PA tracker. The PA tracker will also include a smartphone or web-based application, where participants can upload their exercise performed each day, and keep up to date with their goals using their smartphone or by logging on to their computer. The aim of the study is to find out how useful and effective technology with support from a healthcare professional is in helping cancer survivors to become more physically active. This study will measure objective PA levels of the participants at the start of the study and at the end. The acceptability of using this intervention to promote PA in cancer survivors will also be investigated.
The overall aim is to determine the feasibility of a specific PA intervention, combining technology and professional input, in the cancer survivor population. Study Design: A single arm feasibility trial of a PA intervention using technology and behavioural change theories as tools to achieve increased PA. Participants in the study will receive 12 weeks of the intervention. Outcomes will be measured at baseline, 12 weeks and 24 weeks (+/- 2 weeks) post baseline. Patient recruitment: Participants will be recruited from those attending the St. James' Hospital oncology and haematology services. Study personnel will provide further information to these patients and assess them for eligibility. Informed consent will be gained from each participant. Sample size: Proposed sample size is 60 (based on Sim and Lewis, 2012 recommendations) and allowing for 20% drop-out. Intervention: This study will use the commercially available 'Fitbit' wearable technology with its paired smartphone application. PA goals will be prescribed by a qualified, chartered physiotherapist using the American Cancer Society (ACS) guidelines (Doyle et al 2006). Participants will use the Fitbit and its paired application for 12 weeks. The Fitbit device is a tool for motivation and monitoring of PA behaviours in this intervention. This study will also use evidence-based psychological behavioural change theory. Behavioural change techniques include 'self-monitoring of behaviour', 'goal-setting', 'feedback on behaviour' and 'information about health consequences'. Procedures: This study includes time-points at baseline, 12 weeks (Intervention end) and 24 weeks post baseline (+/- 2 weeks (Follow-up). Pre-intervention:Consent and PA measurement * Consent: Study personnel meets potential participants at their outpatient appointment. The agreement of the patient's consultant to exercise has been obtained before the patient information leaflet (PIL) is provided. The researcher explains the study and gives the potential participant a consent form and a patient information leaflet and a verbal explanation of the study. * Initial PA measurement: Participants who consent are given an Actigraph PA monitor which they will be instructed to wear for 7 days to measure their baseline physical activity levels. Participants who wish to consider the study can take the PIL home, post it back, and receive the Actigraph by post. Baseline Session: Participants attend * 1\) An educational session, delivered by the lead researcher, a chartered physiotherapist. This is a group information session on PA following cancer treatment. * 2\) Educational session to introduce the technological component to the participants and instruct them in use and upload of Fitbit data to allow monitoring by researcher(s). * 3\) Measurement of height, weight, BMI and body composition and 6 minute walk test During intervention. (week 1-12) * Participants wear Fitbit and upload data for self-monitoring and monitoring by chartered physiotherapist researcher. * Participants receive scheduled structured telephone calls, giving them feedback on their achievement of goals and reminders about uploading data as follows; 2 calls each week till week 4, 1 call a week between week 4 and 8 and 2 calls, 2 weeks apart between week 8 and week 12. After intervention ends (12 weeks): * Measurement of height, weight, BMI and body composition and 6 minute walk test * Participants wear Actigraph x 7 days 12 weeks after end of intervention: * Measurement of height, weight, BMI and body composition and 6 minute walk test * Participants wear Actigraph x 7 days
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
60
A physical activity intervention, delivered remotely using a combination of the Fitbit application and support from a chartered physiotherapist.
St. James's Hospital Dublin
Dublin, Ireland
Change in Physical Activity (Objective)
Accelerometry will be used to monitor 7 days of activity at Week 0, Week 12 (+/- 2 weeks) and 24 weeks (+/- 2 weeks) post baseline.
Time frame: Baseline, 12 weeks, 24 weeks
Evaluation of recruitment capability and resulting sample characteristics
The number of participants we can recruit will be assessed. This will explore the potential sample size of the randomised control trial.
Time frame: 12 weeks
Data collection procedures and outcome measures
Procedures to collect data will be assessed for suitability and outcome measures used will be analysed for optimisation of measurement of clinical outcomes
Time frame: 12 weeks
Acceptability and suitability of the intervention and study procedures
Compliance with daily logging of exercise information and adherence to the intervention duration will be assessed
Time frame: 12 weeks
Use of resources and ability to manage and implement the study and intervention
The ability of study personnel and the availability of resources to implement the study will be assessed, demonstrated by successful implementation of the intervention
Time frame: 12 weeks
Preliminary evaluation of participant responses to intervention
The qualitative outcome in this feasibility study will invite participants' to provide feedback on the intervention's likelihood of being successful. Satisfaction with the technological intervention will be measured using a questionnaire given to participants at study end (12 weeks).
Time frame: 12 weeks
Change in body composition
This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in percentage body fat.
Time frame: Baseline, 12 weeks and 24 weeks
Change in self-report PA
A modified version of the Godin Leisure Time Exercise Questionnaire will be used.
Time frame: Baseline, 12 weeks and 24 weeks
Change in quality of life
The FACT-G scale (general) (Cella et al 1993) will be used to assess quality of life.
Time frame: Baseline, 12 weeks and 24 weeks
Change in aerobic capacity/endurance
This will be measured using the 6MWT (Six minute walk test).
Time frame: Baseline,12 weeks and 24 weeks
Change in BMI
This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in kg/m\^2.
Time frame: Baseline, 12 weeks and 24 weeks
Change in Body Weight (kg)
This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in kg.
Time frame: Baseline,12 weeks and 24 weeks
Change in waist circumference
This will be measured at baseline, 12 weeks (Intervention end) and 24 weeks post -baseline (Follow-up). This will be measured in cm.
Time frame: Baseline,12 weeks and 24 weeks
Change in quality of life
The physical functional measure of the SF-36 (Brazier et al 1992) will be used to measure quality of life.
Time frame: Baseline,12 weeks and 24 weeks
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