CancerPERCSNCT05615285
Personalised Exercise Rehabilitation for Cancer Survivorship
A study testing PERCS Triage and Referral System in people with Cancer, run by University of Dublin, Trinity College at 1 site in Ireland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- PERCS Triage and Referral System
- How many people
- 70 participants
- Where
- 1 siteIreland
- Study dates
- 12 Dec 2022to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
Rehabilitation pathways are as follows:
- Participants who are currently active and have no cancer-specific impairments will receive advice from the physiotherapist on maintaining their current levels of activity.
- 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.
- 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.
Read the 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:
- Participants who are currently active and have no cancer-specific impairments will receive advice from the physiotherapist on maintaining their current levels of activity.
- 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.
- 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
- Cancer
- Being tested
- PERCS Triage and Referral System
- Keywords
- Cancer rehabilitation, Exercise, Triage
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PERCS Triage and Referral SystemOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
RE-AIM Framework
Evaluation of system Reach, Effectiveness, Adoption, Implementation, Maintenance
Measured: Data reported by 12 months
Percentage of patients on Prehabilitation list which are eligible for the study
Referral - Eligible referral rate from prehabilitation group
Measured: 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
Measured: Data reported by 12 months
Percentage of people enrolled in study who have received both recruitment letter and phone call
Enrolment rate
Measured: Data reported by 12 months
Percentage of people attending scheduled assessments at i. T0 and ii. T1
Assessment completion rate
Measured: 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
Measured: Data reported by 12 months
Percentage of people who attended T0 assessment that attend T1 assessment
Attrition rate - assessments
Measured: 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
Measured: 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
Measured: Data reported by 12 months
Number and nature of adverse events occurring in assessment process
Adverse events
Measured: Data reported by 12 months
Information related to feasibility gathered from semi-structured interviews with participants
Qualitative feasibility
Measured: Data reported by 12 months
Secondary outcomes (19)
International Physical Activity Questionnaire
Physical activity levels assessment Health Behaviour and Stages of Change Questionnaire Self-Efficacy for Exercise Scale
Measured: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Health Behaviour and Stages of Change Questionnaire
Readiness to change assessment Health Behaviour and Stages of Change Questionnaire Self-Efficacy for Exercise Scale
Measured: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Self-efficacy for exercise scale
Physical activity self efficacy assessment Health Behaviour and Stages of Change Questionnaire Self-Efficacy for Exercise Scale
Measured: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Patient specific funcational scale
Self-reported function. Scale from 0 - 10, higher score indicates higher perceived ability to do task
Measured: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Timed Up and Go
Falls Risk
Measured: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Hand grip strength
Muscle strength
Measured: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
30 second Sit-to-Stand
Funcational lower body strength
Measured: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Six minute walk test
aerobic capacity \&endurance
Measured: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Height
Anthropometrics
Measured: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Weight
Anthropometrics
Measured: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Waist Circumference
Anthropometrics
Measured: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Mid-arm Circumference
Anthropometrics
Measured: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Mini Nutritional Assessment
Nutritional
Measured: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
EOCG-PS
Performance status
Measured: 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)
Quality of life
Measured: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Multidimensional Fatigue Inventory (MFI-20)
Fatigue
Measured: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Hospital Anxiety and Depression Scale (HADS)
Anxiety \& depression; Scale from 0 - 21, higher score indicates higher levels of anxiety and/or depression.
Measured: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Sociodemographic details
Measured: T0 assessment; data reported by 12 months
Medical history
Measured: T0 assessment; data reported by 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start12 Dec 2022
- Primary completion30 Sep 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Collaborators
- Irish Cancer Society, National Cancer Control Programme, Ireland, Trinity St James's Cancer Institute, Dublin, Ireland, Royal College of Surgeons, Ireland, Technological University Dublin, Ireland, La Trobe University, Melbourne, Australia, Wellcome Trust
- Responsible party
- Principal investigator, Emer Guinan, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615285
- Sponsor's protocol ID
- PERCS
- Acronym
- PERCS
- Status last verified
- Nov 2023
- First submitted
- 21 Oct 2022
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40146479Brennan 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. 2026 Apr;20(2):752-765. doi: 10.1007/s11764-024-01684-2. Epub 2024 Nov 12.
PubMed 39528780Brennan 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.
PubMed 38654198
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalised Exercise Rehabilitation for Cancer Survivorship
- ClinicalTrials.gov ID
- NCT05615285
- Acronym / sponsor ID
- PERCS / PERCS
- Conditions
- Cancer
- Keywords
- Cancer rehabilitation, Exercise, Triage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Collaborators
- Irish Cancer Society, National Cancer Control Programme, Ireland, Trinity St James's Cancer Institute, Dublin, Ireland, Royal College of Surgeons, Ireland, Technological University Dublin, Ireland, La Trobe University, Melbourne, Australia, Wellcome Trust
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Participants who are currently active and have no cancer-specific impairments will receive advice from the physiotherapist on maintaining their current levels of activity.
- 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.
- 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:
- Participants who are currently active and have no cancer-specific impairments will receive advice from the physiotherapist on maintaining their current levels of activity.
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- 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.
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients will be eligible to participate if they:
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PERCS Triage and Referral SystemParticipants 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. | Other | – |
Primary outcome
RE-AIM Framework
Time frame: Data reported by 12 months
Evaluation of system Reach, Effectiveness, Adoption, Implementation, Maintenance
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
Percentage of people attending scheduled assessments at i. T0 and ii. T1
Time frame: Data reported by 12 months
Assessment completion rate
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
Percentage of people who attended T0 assessment that attend T1 assessment
Time frame: Data reported by 12 months
Attrition rate - assessments
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
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
Information related to feasibility gathered from semi-structured interviews with participants
Time frame: Data reported by 12 months
Qualitative feasibility
19 secondary outcomes
International Physical Activity Questionnaire
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Health Behaviour and Stages of Change Questionnaire
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Self-efficacy for exercise scale
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Patient specific funcational scale
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Timed Up and Go
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Hand grip strength
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
30 second Sit-to-Stand
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Six minute walk test
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Height
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Weight
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Waist Circumference
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Mid-arm Circumference
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Mini Nutritional Assessment
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
EOCG-PS
Time frame: 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)
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Multidimensional Fatigue Inventory (MFI-20)
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Hospital Anxiety and Depression Scale (HADS)
Time frame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
Sociodemographic details
Time frame: T0 assessment; data reported by 12 months
Medical history
Time frame: T0 assessment; data reported by 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Derived from this study: PubMed 40146479Brennan 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.
- Derived from this study: PubMed 39528780Brennan 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. 2026 Apr;20(2):752-765. doi: 10.1007/s11764-024-01684-2. Epub 2024 Nov 12.
- Derived from this study: PubMed 38654198Brennan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PERCS Triage and Referral System in people with Cancer, run by University of Dublin, Trinity College at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RE-AIM Framework (time frame: Data reported by 12 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05615285, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.