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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05615285
Other study ID # PERCS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 12, 2022
Est. completion date October 31, 2023

Study information

Verified date November 2023
Source University of Dublin, Trinity College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
Ireland Clinical Research Facility, St James's Hospital Dublin

Sponsors (8)

Lead Sponsor Collaborator
University of Dublin, Trinity College 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-HRB Clinical Research Facility, St James's Hospital, Dublin, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Primary RE-AIM Framework Evaluation of system Reach, Effectiveness, Adoption, Implementation, Maintenance Data reported by 12 months
Primary Percentage of patients on Prehabilitation list which are eligible for the study Referral - Eligible referral rate from prehabilitation group Data reported by 12 months
Primary 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
Primary Percentage of people enrolled in study who have received both recruitment letter and phone call Enrolment rate Data reported by 12 months
Primary Percentage of people attending scheduled assessments at i. T0 and ii. T1 Assessment completion rate Data reported by 12 months
Primary 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
Primary Percentage of people who attended T0 assessment that attend T1 assessment Attrition rate - assessments Data reported by 12 months
Primary 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
Primary 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
Primary Number and nature of adverse events occurring in assessment process Adverse events Data reported by 12 months
Primary Information related to feasibility gathered from semi-structured interviews with participants Qualitative feasibility Data reported by 12 months
Secondary International Physical Activity Questionnaire Physical activity levels assessment Health Behaviour and Stages of Change Questionnaire Self-Efficacy for Exercise Scale T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Secondary Health Behaviour and Stages of Change Questionnaire Readiness to change assessment Health Behaviour and Stages of Change Questionnaire Self-Efficacy for Exercise Scale T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Secondary Self-efficacy for exercise scale Physical activity self efficacy assessment Health Behaviour and Stages of Change Questionnaire Self-Efficacy for Exercise Scale T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Secondary Patient specific funcational scale Self-reported function. Scale from 0 - 10, higher score indicates higher perceived ability to do task T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Secondary Timed Up and Go Falls Risk T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Secondary Hand grip strength Muscle strength T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Secondary 30 second Sit-to-Stand Funcational lower body strength T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Secondary Six minute walk test aerobic capacity &endurance T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Secondary Height Anthropometrics T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Secondary Weight Anthropometrics T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Secondary Waist Circumference Anthropometrics T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Secondary Mid-arm Circumference Anthropometrics T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Secondary Mini Nutritional Assessment Nutritional T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Secondary EOCG-PS Performance status T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Secondary European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC- QLQ-C30) Quality of life T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Secondary Multidimensional Fatigue Inventory (MFI-20) Fatigue T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Secondary Hospital Anxiety and Depression Scale (HADS) Anxiety & depression; Scale from 0 - 21, higher score indicates higher levels of anxiety and/or depression. T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Secondary Sociodemographic details T0 assessment; data reported by 12 months
Secondary Medical history T0 assessment; data reported by 12 months
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