MedDataX Logo

Personalised Exercise Rehabilitation for Cancer Survivorship

NCT ID: NCT05615285

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-12

Study Completion Date

2023-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Cancer rehabilitation Exercise Triage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Implementation study designed to operate closely to clinical practice: no masking appropriate or required.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PERCS Triage and Referral System

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Irish Cancer Society

OTHER

Sponsor Role collaborator

National Cancer Control Programme, Ireland

UNKNOWN

Sponsor Role collaborator

Trinity St James's Cancer Institute, Dublin, Ireland

UNKNOWN

Sponsor Role collaborator

Royal College of Surgeons, Ireland

OTHER

Sponsor Role collaborator

Technological University Dublin, Ireland

UNKNOWN

Sponsor Role collaborator

La Trobe University, Melbourne, Australia

UNKNOWN

Sponsor Role collaborator

Wellcome Trust

OTHER

Sponsor Role collaborator

University of Dublin, Trinity College

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Emer Guinan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinical Research Facility, St James's Hospital

Dublin, , Ireland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Ireland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40146479 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39528780 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38654198 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PERCS

Identifier Type: -

Identifier Source: org_study_id