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Completed

NCT Number: NCT05615285

Personalised Exercise Rehabilitation for Cancer Survivorship

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Facility, St James's Hospital

Dublin, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PERCS Triage and Referral System

Other

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.

Primary outcomes

  1. RE-AIM Framework

    Time frame: Data reported by 12 months

    Evaluation of system Reach, Effectiveness, Adoption, Implementation, Maintenance

  2. 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

  3. 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

  4. Percentage of people enrolled in study who have received both recruitment letter and phone call

    Time frame: Data reported by 12 months

    Enrolment rate

  5. Percentage of people attending scheduled assessments at i. T0 and ii. T1

    Time frame: Data reported by 12 months

    Assessment completion rate

  6. 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

  7. Percentage of people who attended T0 assessment that attend T1 assessment

    Time frame: Data reported by 12 months

    Attrition rate - assessments

  8. 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

  9. 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

  10. Number and nature of adverse events occurring in assessment process

    Time frame: Data reported by 12 months

    Adverse events

  11. Information related to feasibility gathered from semi-structured interviews with participants

    Time frame: Data reported by 12 months

    Qualitative feasibility

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Timed Up and Go

    Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months

    Falls Risk

  6. Hand grip strength

    Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months

    Muscle strength

  7. 30 second Sit-to-Stand

    Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months

    Funcational lower body strength

  8. Six minute walk test

    Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months

    aerobic capacity &endurance

  9. Height

    Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months

    Anthropometrics

  10. Weight

    Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months

    Anthropometrics

  11. Waist Circumference

    Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months

    Anthropometrics

  12. Mid-arm Circumference

    Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months

    Anthropometrics

  13. Mini Nutritional Assessment

    Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months

    Nutritional

  14. EOCG-PS

    Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months

    Performance status

  15. 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

  16. Multidimensional Fatigue Inventory (MFI-20)

    Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months

    Fatigue

  17. 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.

  18. Sociodemographic details

    Time frame: T0 assessment; data reported by 12 months

  19. Medical history

    Time frame: T0 assessment; data reported by 12 months

Sponsors and collaborators

Lead sponsor

University of Dublin, Trinity College

Other

Collaborators

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

Registry information

Acronym: PERCS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 14, 2022
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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