None listed
Conditions
Brief summary
This study is investigating if a physiotherapy led assessment and management service based on a stepped care framework where people are referred to the most appropriate exercise service for their needs, for people with prostate cancer is feasible as compared to usual care without physiotherapy assessment and management. Who is it for? You may be eligible for this trial if you are aged 18 years or over, within 6 months of prostate cancer diagnosis and living independently in the community. Study details Participants will be randomly allocated to one of two groups: 1) Physiotherapist delivered stepped care for exercise; or 2) usual care without physiotherapy. At 6 months after you start the study, data regarding quality of life, physical capacity and health service utilisation will be collected. It is hoped this study will determine the feasibility of a steeped model of physiotherapy care aimed at improving physical activity levels after prostate cancer diagnosis.
Interventions
What is the intervention: ProActive (Getting Prostate cancer survivors ACTIVE using the Cancer Rehabilitation to Recreation Framework). Physiotherapist-led exercise support using a stepped approach to care. Patients are referred to hospital-based rehabilitation, community-based exercise/fitness group or local gym following a comprehensive assessment by the physiotherapist. Patients are referred to the most appropriate service depending on their needs whereby those who have high levels of symptom
What is the intervention: ProActive (Getting Prostate cancer survivors ACTIVE using the Cancer Rehabilitation to Recreation Framework). Physiotherapist-led exercise support using a stepped approach to care. Patients are referred to hospital-based rehabilitation, community-based exercise/fitness group or local gym following a comprehensive assessment by the physiotherapist. Patients are referred to the most appropriate service depending on their needs whereby those who have high levels of symptoms, low confidence to exercise and low functional level will be referred to hospital based rehabilitation programs. If patients display higher levels of function, confidence and lower syptoms, they will be referred to community-based exercise with a trained exercise professional or local gym. The comprehensive assessment includes review of patients cancer and other relevant medical history, exercise history, mobility, symptoms, confidence to exercise and exercise capacity using the 6-minute walk or 2 minute step test, 5 times sit to stand test, repetition max testing, timed up and go test and other relevant balance tests as indicated. Clinical decision making is guided by the Personalised Exercise Rehabilitation for Cancer Survivorship (PERCS) algorithm. Types of exercises: Treadmill walking, stationary bike, pin-loaded weights machines, resistance bands, body weight exercise, free weights Mode of delivery; will depend on location of delivery. Rehabilitation and fitness services may be delivered 1:1 or in a group depending on individual needs. Recreation will be individual Who delivers it and their relevant expertise: Physiotherapist trained in oncology and exercise, and behavioural counselling to provide intervention. Local fitness providers who have received education in exercise oncology and supported by a cancer physiotherapist may provide part of the intervention in the community with appropriate patients based on physiotherapist screening. How it is delivered: face to face or phone/online depending on patient preference, individual. Group sessions may be conducted in the community if patient is referred to a local rehabilitation program depending on their needs. How often and for how long: 4 consultation sessions(1x 1 hour, 3x 30 minutes) in 6-month period. These will have a focus on exercise behaviour change and will include exercise demonstration and practice, motivational interviewing style exercise counselling including advice on how to stay active and goalsetting If patients referred to an exercise service, they may participate in supervised exercise 2 to 3 times weekly for periods of 8 to 12 weeks. Supervised exercise will aim to be delivered at moderate intensity and monitored using BORG/RPE scales Where it is delivered: Hospital inpatient/outpatient clinic setting/home, local gym Adherence: Physiotherapy session attendance recorded and an audit of exercise completed in the community
Sponsors
La Trobe University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Aged 18 years and over Diagnosed with prostate cancer within the last 6-months Able to ambulate independently with or without a walking aid Have an Eastern Cooperative Oncology Group score of equal to or less than 2 (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours) Able to communicate in conversational English Able to give written informed consent as recorded in the medical record or as assessed by their treating clinician or trial assessor.
Exclusion criteria
Have a medical condition that contraindicates exercise (e.g., severe immunocompromise; unstable angina, unstable hypertension, or unstable heart failure) or deemed at potential risk of medical deterioration as determined by the research physiotherapist and/or medical team. The physiotherapist will have experience and additional training in exercise and cancer and guided by published recommendations (23). Have a cognitive impairment as determined by their treating clinician Are receiving end of life care.
Outcome results
None listed