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Clinical Trials/NCT05615285
NCT05615285
Completed
N/A

Personalised Exercise Rehabilitation for Cancer Survivorship

University of Dublin, Trinity College1 site in 1 country70 target enrollmentDecember 12, 2022
ConditionsCancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cancer
Sponsor
University of Dublin, Trinity College
Enrollment
70
Locations
1
Primary Endpoint
Percentage of people who attended assessment who proceed to attend level 2 or level 3 referral service
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 12, 2022
End Date
October 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emer Guinan

Assistant Professor

University of Dublin, Trinity College

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

RE-AIM Framework

Time Frame: Data reported by 12 months

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

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

Time Frame: Data reported by 12 months

Assessment completion rate

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

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

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

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

Time Frame: Data reported by 12 months

Enrolment rate

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

Number and nature of adverse events occurring in assessment process

Time Frame: Data reported by 12 months

Adverse events

Percentage of people who attended T0 assessment that attend T1 assessment

Time Frame: Data reported by 12 months

Attrition rate - assessments

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

Time Frame: Data reported by 12 months

Qualitative feasibility

Secondary Outcomes

  • Sociodemographic details(T0 assessment; data reported by 12 months)
  • International Physical Activity Questionnaire(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
  • Timed Up and Go(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
  • Hand grip strength(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
  • Six minute walk test(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
  • Height(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
  • EOCG-PS(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
  • Medical history(T0 assessment; data reported by 12 months)
  • Health Behaviour and Stages of Change Questionnaire(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
  • Self-efficacy for exercise scale(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
  • Patient specific funcational scale(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
  • 30 second Sit-to-Stand(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
  • Weight(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
  • Waist Circumference(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
  • Mid-arm Circumference(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
  • Mini Nutritional Assessment(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)(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
  • Multidimensional Fatigue Inventory (MFI-20)(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)
  • Hospital Anxiety and Depression Scale (HADS)(T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months)

Study Sites (1)

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