PERCS: Personalised Exercise Rehabilitation for Cancer Survivorship

Sponsor
University of Dublin, Trinity College (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05615285
Collaborator
Irish Cancer Society (Other), National Cancer Control Programme, Ireland (Other), Trinity St James's Cancer Institute, Dublin, Ireland (Other), Royal College of Surgeons, Ireland (Other), Technological University Dublin, Ireland (Other), La Trobe University, Melbourne, Australia (Other), Wellcome Trust-HRB Clinical Research Facility, St James's Hospital, Dublin, Ireland (Other)
100
7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: PERCS Triage and Referral System
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
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.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)
Masking Description:
Implementation study designed to operate closely to clinical practice: no masking appropriate or required.
Primary Purpose:
Supportive Care
Official Title:
Personalised Exercise Rehabilitation for Cancer Survivorship
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Outcome Measures

Primary Outcome Measures

  1. RE-AIM Framework [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 [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 [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 [Data reported by 12 months]

    Enrolment rate

  5. Percentage of people attending scheduled assessments at i. T0 and ii. T1 [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 [Data reported by 12 months]

    Attrition rate - referrals

  7. Percentage of people who attended T0 assessment that attend T1 assessment [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 [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 [Data reported by 12 months]

    Triage results

  10. Number and nature of adverse events occurring in assessment process [Data reported by 12 months]

    Adverse events

  11. Information related to feasibility gathered from semi-structured interviews with participants [Data reported by 12 months]

    Qualitative feasibility

Secondary Outcome Measures

  1. International Physical Activity Questionnaire [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 [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 [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 [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 [T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months]

    Falls Risk

  6. Hand grip strength [T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months]

    Muscle strength

  7. 30 second Sit-to-Stand [T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months]

    Funcational lower body strength

  8. Six minute walk test [T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months]

    aerobic capacity &endurance

  9. Height [T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months]

    Anthropometrics

  10. Weight [T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months]

    Anthropometrics

  11. Waist Circumference [T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months]

    Anthropometrics

  12. Mid-arm Circumference [T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months]

    Anthropometrics

  13. Mini Nutritional Assessment [T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months]

    Nutritional

  14. EOCG-PS [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) [T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months]

    Quality of life

  16. Multidimensional Fatigue Inventory (MFI-20) [T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months]

    Fatigue

  17. Hospital Anxiety and Depression Scale (HADS) [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 [T0 assessment; data reported by 12 months]

  19. Medical history [T0 assessment; data reported by 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Emer Guinan, Assistant Professor, University of Dublin, Trinity College
ClinicalTrials.gov Identifier:
NCT05615285
Other Study ID Numbers:
  • PERCS
First Posted:
Nov 14, 2022
Last Update Posted:
Nov 14, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Emer Guinan, Assistant Professor, University of Dublin, Trinity College

Study Results

No Results Posted as of Nov 14, 2022