Clinical Research Facility, St James's Hospital
Dublin, Ireland
NCT Number: NCT05615285
There is strong evidence that exercise can help improve physical and mental wellbeing after treatment for cancer. However, at present, people with cancer in Ireland are not given the opportunity to have an individual assessment of their physical and psychological wellbeing as part of standard care and are not routinely prescribed exercise-based rehabilitation.
The researchers will run and evaluate a system to i. assess physical and psychological wellbeing of people who have completed cancer treatment, ii. apply a rehabilitation triage system, based on findings of the assessment, iii. refer participants to one of three rehabilitation pathways, as per outcome of the triage process.
Rehabilitation pathways are as follows:
1. Participants who are currently active and have no cancer-specific impairments will receive advice from the physiotherapist on maintaining their current levels of activity. 2. Participants who are not active and have no cancer-specific impairments will be referred to a suitable community-based exercise programme. This programme must contain both resistance and aerobic training and should have some level of supervision from a fitness professional. 3. Participants who are not active and have ongoing cancer-specific impairments will be referred to an oncology specialist physiotherapist, funded through this work, at St James's Hospital for assessment and treatment.
All participants will be encouraged to visit www.cancerrehabilitation.ie for information through out the study. Participants will be reassessed 12 weeks after the initial assessment.
The implementation of this system will be evaluated using the RE-AIM framework.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Dublin, Ireland
Background During and following treatment for cancer, people can experience negative side-effects of treatment, including loss of fitness, weakness, fatigue and psychological issues such as depression and anxiety. There is strong evidence that exercise can help improve these symptoms. The impact of the COVID-19 pandemic means that many people who had cancer treatment since March 2020 may need additional support to achieve optimum physical and psychological wellbeing. At present, people with cancer in Ireland are not given the opportunity to have an individual assessment of their physical and psychological wellbeing as part of standard care and are not routinely prescribed exercise-based rehabilitation.
Aim To run and evaluate an exercise-based rehabilitation triage and assessment clinic for people who had cancer treatment since the beginning of the COVID-19 pandemic.
Study Design:
Patients who were diagnosed with cancer in St James Hospital since March 2020 will be invited to participate in the study. Participants will attend an appointment with a physiotherapist, who will assess their physical and mental wellbeing. On the basis of the assessment findings, participants will be assigned to one of three categories, which will determine their ongoing rehabilitation plan. The three categories are as follows:
All participants will also be advised to visit a website designed by the PERCS research group through a co-design process with patient representatives (www.cancerrehabilitation.ie.) Participants will receive a follow-up phone call one week after the first assessment and will then be re-assessed 12 weeks after the first assessment. A further follow-up phone call will be conducted, if the PERCS research team feel it is needed.
The assessment and triage clinic will be assessed using a framework for evaluating intervention; this will look at how the intervention was implemented and how it will best operate in future practice.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Anyone who is unable to provide informed consent Any person with known or signs or symptoms suggestive of cardiovascular, metabolic or renal disease will require medical clearance from a physiotherapist or medical professional prior to participation, based on criteria outlined in the Safety Reference Guide to support the safe delivery of exercise services to people with cancer by Santa Mina et al. (2018). Preparticipation screening will be completed in accordance with the American College of Sports Medicine Preparticipation health screening recommendations.
Participants will undergo an assessment of physical function and psychosocial wellbeing. Researchers will apply a triage algorithm, based on findings of assessment. Participants will be referred to one of three exercise-based rehabilitation pathways which will best meet their rehabilitation needs. Participants will be re-assessed after 12 weeks. System will be evaluated using RE-AIM framework.
Time frame: Data reported by 12 months
Evaluation of system Reach, Effectiveness, Adoption, Implementation, Maintenance
Time frame: Data reported by 12 months
Referral - Eligible referral rate from prehabilitation group
Time frame: Data reported by 12 months
Referral - Eligible referral rate from clinical teams
Time frame: Data reported by 12 months
Enrolment rate
Time frame: Data reported by 12 months
Assessment completion rate
Time frame: Data reported by 12 months
Attrition rate - referrals
Time frame: Data reported by 12 months
Attrition rate - assessments
Time frame: Data reported by 12 months
Referral outcome - time frame and acceptance
Time frame: Data reported by 12 months
Triage results
Time frame: Data reported by 12 months
Adverse events
Time frame: Data reported by 12 months
Qualitative feasibility
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Physical activity levels assessment Health Behaviour and Stages of Change Questionnaire Self-Efficacy for Exercise Scale
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Readiness to change assessment Health Behaviour and Stages of Change Questionnaire Self-Efficacy for Exercise Scale
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Physical activity self efficacy assessment Health Behaviour and Stages of Change Questionnaire Self-Efficacy for Exercise Scale
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Self-reported function. Scale from 0 - 10, higher score indicates higher perceived ability to do task
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Falls Risk
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Muscle strength
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Funcational lower body strength
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
aerobic capacity &endurance
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Anthropometrics
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Anthropometrics
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Anthropometrics
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Anthropometrics
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Nutritional
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Performance status
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Quality of life
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Fatigue
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Anxiety & depression; Scale from 0 - 21, higher score indicates higher levels of anxiety and/or depression.
Time frame: T0 assessment; data reported by 12 months
Time frame: T0 assessment; data reported by 12 months
University of Dublin, Trinity College
Other
Acronym: PERCS
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