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Personalised Exercise Rehabilitation for Cancer Survivorship

Personalised Exercise Rehabilitation for Cancer Survivorship

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05615285
Acronym
PERCS
Enrollment
70
Registered
2022-11-14
Start date
2022-12-12
Completion date
2023-10-31
Last updated
2023-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Cancer rehabilitation, Exercise, Triage

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: 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.

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: 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 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.

Interventions

OTHERPERCS 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.

Sponsors

Irish Cancer Society
CollaboratorOTHER
National Cancer Control Programme, Ireland
CollaboratorUNKNOWN
Trinity St James's Cancer Institute, Dublin, Ireland
CollaboratorUNKNOWN
Royal College of Surgeons, Ireland
CollaboratorOTHER
Technological University Dublin, Ireland
CollaboratorUNKNOWN
La Trobe University, Melbourne, Australia
CollaboratorUNKNOWN
Wellcome Trust
CollaboratorOTHER
University of Dublin, Trinity College
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

Implementation study designed to operate closely to clinical practice: no masking appropriate or required.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients will be eligible to participate if they: 1. Were diagnosed with cancer at St James's Hospital since March 2020 2. Have completed adjuvant chemotherapy and/or radiotherapy 3. Are at least 6 weeks post-surgery 4. Do not show signs of recurrent or metastatic disease at the time of enrolment 5. 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.

Design outcomes

Primary

MeasureTime frameDescription
i. Time from assessment to referral being sent ii. Percentage of referral accepted at initial site iii. Time from referral sent to initial appointmentData reported by 12 monthsReferral outcome - time frame and acceptance
RE-AIM FrameworkData reported by 12 monthsEvaluation of system Reach, Effectiveness, Adoption, Implementation, Maintenance
Percentage of patients on Prehabilitation list which are eligible for the studyData reported by 12 monthsReferral - Eligible referral rate from prehabilitation group
The percentage of referrals to the study from clinical team which are eligible for the studyData reported by 12 monthsReferral - Eligible referral rate from clinical teams
Percentage of people enrolled in study who have received both recruitment letter and phone callData reported by 12 monthsEnrolment rate
Percentage of people attending scheduled assessments at i. T0 and ii. T1Data reported by 12 monthsAssessment completion rate
Percentage of people who attended assessment who proceed to attend level 2 or level 3 referral serviceData reported by 12 monthsAttrition rate - referrals
Percentage of people who attended T0 assessment that attend T1 assessmentData reported by 12 monthsAttrition rate - assessments
i. Percentage of people triaged to each level (1, 2 or 3) ii. Percentage triaged to another level after initial triage and whyData reported by 12 monthsTriage results
Number and nature of adverse events occurring in assessment processData reported by 12 monthsAdverse events
Information related to feasibility gathered from semi-structured interviews with participantsData reported by 12 monthsQualitative feasibility

Secondary

MeasureTime frameDescription
Mid-arm CircumferenceT0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 monthsAnthropometrics
Mini Nutritional AssessmentT0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 monthsNutritional
EOCG-PST0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 monthsPerformance status
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC- QLQ-C30)T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 monthsQuality of life
International Physical Activity QuestionnaireT0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 monthsPhysical activity levels assessment Health Behaviour and Stages of Change Questionnaire Self-Efficacy for Exercise Scale
Hospital Anxiety and Depression Scale (HADS)T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 monthsAnxiety & depression; Scale from 0 - 21, higher score indicates higher levels of anxiety and/or depression.
Sociodemographic detailsT0 assessment; data reported by 12 months
Medical historyT0 assessment; data reported by 12 months
Multidimensional Fatigue Inventory (MFI-20)T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 monthsFatigue
Health Behaviour and Stages of Change QuestionnaireT0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 monthsReadiness to change assessment Health Behaviour and Stages of Change Questionnaire Self-Efficacy for Exercise Scale
Self-efficacy for exercise scaleT0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 monthsPhysical activity self efficacy assessment Health Behaviour and Stages of Change Questionnaire Self-Efficacy for Exercise Scale
Patient specific funcational scaleT0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 monthsSelf-reported function. Scale from 0 - 10, higher score indicates higher perceived ability to do task
Timed Up and GoT0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 monthsFalls Risk
Hand grip strengthT0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 monthsMuscle strength
30 second Sit-to-StandT0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 monthsFuncational lower body strength
Six minute walk testT0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 monthsaerobic capacity &endurance
HeightT0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 monthsAnthropometrics
WeightT0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 monthsAnthropometrics
Waist CircumferenceT0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 monthsAnthropometrics

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026