Personalised Exercise Rehabilitation for Cancer Survivorship

NCT05615285 | Completed

• 1 other identifier: PERCS
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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. 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. 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. 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.

Conditions

Cancer

Keywords

Cancer rehabilitation; Exercise; Triage

Outcome Measures

Primary Outcomes (11)

• RE-AIM Framework

  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

  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

  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

  Enrolment rate

  Data reported by 12 months

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

  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

  Attrition rate - referrals

  Data reported by 12 months

• Percentage of people who attended T0 assessment that attend T1 assessment

  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

  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

  Triage results

  Data reported by 12 months

• Number and nature of adverse events occurring in assessment process

  Adverse events

  Data reported by 12 months

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

  Qualitative feasibility

  Data reported by 12 months

Secondary Outcomes (19)

• International Physical Activity Questionnaire

  T0 assessment, T1 (+12 weeks from 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

• Timed Up and Go

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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Clinical Research Facility, St James's Hospital

Dublin, Ireland

Location

Related Publications (3)

• Brennan L, Kennedy M, Grehan S, Connolly H, Sheill G, Donohoe CL, Guinan E. Patient experiences of participating in a cancer rehabilitation triage and referral system in the Irish healthcare system. J Cancer Surviv. 2025 Mar 27. doi: 10.1007/s11764-025-01785-6. Online ahead of print.

  PMID: 40146479 DERIVED

• Brennan L, Sheill G, Collier S, Browne P, Donohoe C, Guinan E. Personalised exercise rehabilitation in cancer survivorship: Findings from a triage and referral feasibility study. J Cancer Surviv. 2024 Nov 12. doi: 10.1007/s11764-024-01684-2. Online ahead of print.

  PMID: 39528780 DERIVED

• Brennan L, Sheill G, Collier S, Browne P, Donohoe CL, O'Neill L, Hussey J, Guinan EM. Personalised exercise rehabilitation in cancer survivorship: the percs triage and referral system study protocol. BMC Cancer. 2024 Apr 23;24(1):517. doi: 10.1186/s12885-024-12266-x.

  PMID: 38654198 DERIVED

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Implementation study designed to operate closely to clinical practice: no masking appropriate or required.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: November 14, 2022
• Study Start: December 12, 2022
• Primary Completion: September 30, 2023
• Study Completion: October 31, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)