- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05615285
Personalised Exercise Rehabilitation for Cancer Survivorship (PERCS)
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Dublin, Ireland
- Clinical Research Facility, St James's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
RE-AIM Framework
Time Frame: Data reported by 12 months
|
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
Time Frame: Data reported by 12 months
|
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
Time Frame: Data reported by 12 months
|
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
Time Frame: Data reported by 12 months
|
Enrolment rate
|
Data reported by 12 months
|
Percentage of people attending scheduled assessments at i. T0 and ii. T1
Time Frame: Data reported by 12 months
|
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
Time Frame: Data reported by 12 months
|
Attrition rate - referrals
|
Data reported by 12 months
|
Percentage of people who attended T0 assessment that attend T1 assessment
Time Frame: Data reported by 12 months
|
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
Time Frame: Data reported by 12 months
|
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
Time Frame: Data reported by 12 months
|
Triage results
|
Data reported by 12 months
|
Number and nature of adverse events occurring in assessment process
Time Frame: Data reported by 12 months
|
Adverse events
|
Data reported by 12 months
|
Information related to feasibility gathered from semi-structured interviews with participants
Time Frame: Data reported by 12 months
|
Qualitative feasibility
|
Data reported by 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
International Physical Activity Questionnaire
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
|
T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
|
Health Behaviour and Stages of Change Questionnaire
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
|
T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
|
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
|
T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
|
Patient specific funcational 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
|
T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
|
Timed Up and Go
Time Frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
|
Falls Risk
|
T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
|
Hand grip strength
Time Frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
|
Muscle strength
|
T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
|
30 second Sit-to-Stand
Time Frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
|
Funcational lower body strength
|
T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
|
Six minute walk test
Time Frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
|
aerobic capacity &endurance
|
T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
|
Height
Time Frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
|
Anthropometrics
|
T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
|
Weight
Time Frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
|
Anthropometrics
|
T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
|
Waist Circumference
Time Frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
|
Anthropometrics
|
T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
|
Mid-arm Circumference
Time Frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
|
Anthropometrics
|
T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
|
Mini Nutritional Assessment
Time Frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
|
Nutritional
|
T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
|
EOCG-PS
Time Frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
|
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)
Time Frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
|
Quality of life
|
T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
|
Multidimensional Fatigue Inventory (MFI-20)
Time Frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
|
Fatigue
|
T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
|
Hospital Anxiety and Depression Scale (HADS)
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.
|
T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
|
Sociodemographic details
Time Frame: T0 assessment; data reported by 12 months
|
T0 assessment; data reported by 12 months
|
|
Medical history
Time Frame: T0 assessment; data reported by 12 months
|
T0 assessment; data reported by 12 months
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PERCS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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