Personalised Exercise Rehabilitation for Cancer Survivorship (PERCS)

November 28, 2023 updated by: Emer Guinan, University of Dublin, Trinity College

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Louise Brennan, PhD
  • Phone Number: 0035318964809
  • Email: brennl10@tcd.ie

Study Contact Backup

  • Name: Emer Guinan, PhD
  • Phone Number: 0035318964809
  • Email: guinane1@tcd.ie

Study Locations

  • Ireland
      • Dublin, Ireland
        • Clinical Research Facility, St James's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Dublin, Trinity College

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Royal College of Surgeons, Ireland
Irish Cancer Society
National Cancer Control Programme, Ireland
Trinity St James's Cancer Institute, Dublin, Ireland
Technological University Dublin, Ireland
La Trobe University, Melbourne, Australia
Wellcome Trust-HRB Clinical Research Facility, St James's Hospital, Dublin, Ireland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 12, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PERCS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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