Personalised Exercise Rehabilitation for Cancer Survivorship

Cancer Clinical Trial

— PERCS  

Official title:

Personalised Exercise Rehabilitation for Cancer Survivorship

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05615285
• Other study ID #: PERCS
• Status: Completed
• Phase: N/A
• 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
• 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

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