Clinical trial NCT05615285: Personalised Exercise Rehabilitation for Cancer Survivorship
Official title: Personalised Exercise Rehabilitation for Cancer Survivorship
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Cancer rehabilitation
Exercise
Triage
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
Collaborators: name: Irish Cancer Society
name: National Cancer Control Programme, Ireland
name: Trinity St James's Cancer Institute, Dublin, Ireland
name: Royal College of Surgeons, Ireland
name: Technological University Dublin, Ireland
name: La Trobe University, Melbourne, Australia
name: Wellcome Trust
First posted: 2022-11-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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. 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: RE-AIM Framework
timeFrame: Data reported by 12 months
measure: Percentage of patients on Prehabilitation list which are eligible for the study
timeFrame: Data reported by 12 months
measure: The percentage of referrals to the study from clinical team which are eligible for the study
timeFrame: Data reported by 12 months
measure: Percentage of people enrolled in study who have received both recruitment letter and phone call
timeFrame: Data reported by 12 months
measure: Percentage of people attending scheduled assessments at i. T0 and ii. T1
timeFrame: Data reported by 12 months
measure: Percentage of people who attended assessment who proceed to attend level 2 or level 3 referral service
timeFrame: Data reported by 12 months
measure: Percentage of people who attended T0 assessment that attend T1 assessment
timeFrame: Data reported by 12 months
measure: i. Time from assessment to referral being sent ii. Percentage of referral accepted at initial site iii. Time from referral sent to initial appointment
timeFrame: Data reported by 12 months
measure: i. Percentage of people triaged to each level (1, 2 or 3) ii. Percentage triaged to another level after initial triage and why
timeFrame: Data reported by 12 months
measure: Number and nature of adverse events occurring in assessment process
timeFrame: Data reported by 12 months
measure: Information related to feasibility gathered from semi-structured interviews with participants
timeFrame: Data reported by 12 months
Secondary outcomes:
measure: International Physical Activity Questionnaire
timeFrame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
measure: Health Behaviour and Stages of Change Questionnaire
timeFrame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
measure: Self-efficacy for exercise scale
timeFrame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
measure: Patient specific funcational scale
timeFrame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
measure: Timed Up and Go
timeFrame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
measure: Hand grip strength
timeFrame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
measure: 30 second Sit-to-Stand
timeFrame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
measure: Six minute walk test
timeFrame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
measure: Height
timeFrame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
measure: Weight
timeFrame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
measure: Waist Circumference
timeFrame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
measure: Mid-arm Circumference
timeFrame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
measure: Mini Nutritional Assessment
timeFrame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
measure: EOCG-PS
timeFrame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC- QLQ-C30)
timeFrame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
measure: Multidimensional Fatigue Inventory (MFI-20)
timeFrame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: T0 assessment, T1 (+12 weeks from T0 assessment); data reported by 12 months
measure: Sociodemographic details
timeFrame: T0 assessment; data reported by 12 months
measure: Medical history
timeFrame: T0 assessment; data reported by 12 months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Clinical Research Facility, St James's Hospital
Study officials:
References: