Personalised Exercise Rehabilitation for Cancer Survivorship

Study Overview
=================
Brief Summary
-----------------
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: Participants who are currently active and have no cancer-specific impairments will receive advice from the physiotherapist on maintaining their current levels of activity. 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. 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.

Detailed Description
-----------------
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: Participants who are currently active and have no cancer-specific impairments will receive advice from the physiotherapist on maintaining their current levels of activity. 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. 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 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.

Official Title
-----------------
Personalised Exercise Rehabilitation for Cancer Survivorship

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Other: PERCS Triage and Referral System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will be eligible to participate if they: Were diagnosed with cancer at St James's Hospital since March 2020 Have completed adjuvant chemotherapy and/or radiotherapy Are at least 6 weeks post-surgery Do not show signs of recurrent or metastatic disease at the time of enrolment Are over the age of 18 years 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: A feasibility and implementation study of the PERCS triage and referral system. Participants are triaged into one of three groups, but the outcomes of the groups will not be compared from an intervention perspective. The system will be evaluated as a whole.
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: PERCS Triage and Referral System|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.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RE-AIM Framework | Evaluation of system Reach, Effectiveness, Adoption, Implementation, Maintenance | Data reported by 12 months | 
| Percentage of patients on Prehabilitation list which are eligible for the study | Referral - Eligible referral rate from prehabilitation group | Data reported by 12 months | 
| The percentage of referrals to the study from clinical team which are eligible for the study | Referral - Eligible referral rate from clinical teams | Data reported by 12 months | 
| Percentage of people enrolled in study who have received both recruitment letter and phone call | Enrolment rate | Data reported by 12 months | 
| Percentage of people attending scheduled assessments at i. T0 and ii. T1 | Assessment completion rate | Data reported by 12 months | 
| Percentage of people who attended assessment who proceed to attend level 2 or level 3 referral service | Attrition rate - referrals | Data reported by 12 months | 
| Percentage of people who attended T0 assessment that attend T1 assessment | Attrition rate - assessments | Data reported by 12 months | 
| i. Time from assessment to referral being sent ii. Percentage of referral accepted at initial site iii. Time from referral sent to initial appointment | Referral outcome - time frame and acceptance | Data reported by 12 months | 
| i. Percentage of people triaged to each level (1, 2 or 3) ii. Percentage triaged to another level after initial triage and why | Triage results | Data reported by 12 months | 
| Number and nature of adverse events occurring in assessment process | Adverse events | Data reported by 12 months | 
| Information related to feasibility gathered from semi-structured interviews with participants | Qualitative feasibility | Data reported by 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Physical Activity Questionnaire | Physical activity levels assessment Health Behaviour and Stages of Change Questionnaire Self-Efficacy for Exercise Scale | T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months | 
| Health Behaviour and Stages of Change Questionnaire | Readiness to change assessment Health Behaviour and Stages of Change Questionnaire Self-Efficacy for Exercise Scale | T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months | 
| Self-efficacy for exercise scale | Physical activity self efficacy assessment Health Behaviour and Stages of Change Questionnaire Self-Efficacy for Exercise Scale | T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months | 
| Patient specific funcational scale | Self-reported function. Scale from 0 - 10, higher score indicates higher perceived ability to do task | T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months | 
| Timed Up and Go | Falls Risk | T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months | 
| Hand grip strength | Muscle strength | T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months | 
| 30 second Sit-to-Stand | Funcational lower body strength | T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months | 
| Six minute walk test | aerobic capacity &endurance | T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months | 
| Height | Anthropometrics | T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months | 
| Weight | Anthropometrics | T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months | 
| Waist Circumference | Anthropometrics | T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months | 
| Mid-arm Circumference | Anthropometrics | T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months | 
| Mini Nutritional Assessment | Nutritional | T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months | 
| EOCG-PS | Performance status | T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months | 
| European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC- QLQ-C30) | Quality of life | T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months | 
| Multidimensional Fatigue Inventory (MFI-20) | Fatigue | T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months | 
| Hospital Anxiety and Depression Scale (HADS) | Anxiety & depression; Scale from 0 - 21, higher score indicates higher levels of anxiety and/or depression. | T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months | 
| Sociodemographic details |  | T0 assessment; data reported by 12 months | 
| Medical history |  | T0 assessment; data reported by 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer rehabilitation, Exercise, Triage