CancerWesFitNCT03509428
The Wessex Fit-4-Cancer Surgery Trial
A study testing SRETP and Psychological support in people with Cancer, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Trial Phase: Phase III: A multi-centre efficacy pragmatic factorial design randomised controlled trial with patient informed development and process evaluation Indication: Patients undergoing major electively resectable intra - cavity cancer surgery with or without neoadjuvant cancer treatments (including chemotherapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- SRETP and Psychological support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,560 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Mar 2018to 1 Mar 2022
- 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
- Male or female patients
- aged over 18 years old
- scheduled to have major intra-cavity cancer surgery with a curative intent, defined as thoracic, colorectal, oesophagogastric, urological and hepatobiliary (inc. pancreatic).
- surgery alone (unimodal)
- surgery combined (multimodal) with cancer treatments (neoadjuvant chemotherapy, chemoradiotherapy or immunotherapies).
- All patients deemed by the MDT as potentially curable or undergoing neoadjuvant cancer treatments prior to restaging and surgery.
Who cannot join
- Patients will be excluded if under the age of 18 years,
- if their tumour is considered surgically non- resectable,
- having absolute or relative contraindications to completing a CPET,
- patients are unable to perform CPET due to other coexisting acute illness or conditions (e.g. lower limb dysfunction),
- patients decline surgery,
- if their weight exceeds 145kg
- patients unable to give informed consent.
- Patients having >2 mm ST depression if symptomatic or 4 mm if asymptomatic or >1 mm ST elevation during any CPET will need to be withdrawn from study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hopsitals Southampton
Southampton
Sandy Jack, PhD
About this study
Official title: A Pragmatic Factorial Design Randomised Controlled Study to Assess the Efficacy of the Implementation of a Prehabilitation Programme in Patients Undergoing Elective Major Intra - Cavity Cancer Surgery in Wessex
Trial Phase: Phase III: A multi-centre efficacy pragmatic factorial design randomised controlled trial with patient informed development and process evaluation
Indication: Patients undergoing major electively resectable intra - cavity cancer surgery with or without neoadjuvant cancer treatments (including chemotherapy (NAC), chemoradiotherapy (CRT), or immunotherapy).
Read more
Objective: To investigate the efficacy of a community based Structured Responsive Exercise-training Programme (SRETP) ± psychological support on surgical outcome by reducing postoperative length of stay (LOS) and complications.
Secondary Objective:
To investigate the efficacy of a community based Structured Responsive Exercise-training Programme (SRETP) ± psychological support to improve disease-free overall survival. Cardiopulmonary Exercise test (CPET) variables, physical activity, morbidity, radiological markers of sarcopenia, toxicity, tumour down-staging, tumour regression, disability adjusted survival (WHODAS) overall survival and quality of life (QoL).
Read the detailed description
Rationale: Fitter patients have better surgical outcomes. Poor physical fitness measured objectively using cardiopulmonary exercise testing has been associated with increased LOS, increased morbidity and mortality in many patient cohorts undergoing major cancer surgery. Chemotherapy and radiotherapy have detrimental effects on physical fitness, which may in turn have a detrimental effect on the patients' ability to withstand surgery. Research suggests psychological factors including depression and self-efficacy (confidence to manage cancer-related problems) prior to surgery predict recovery trajectories in health-related quality of life up to 2 years after major surgery for colorectal cancer.
The aim is to investigate whether SRETP (Prehabilitation) ± psychological support prior to and during cancer treatment before major elective surgery reduces LOS, increases survival and improves their ability to self manage. Additionally, we aim to see if this intervention can bring about long-term behavioural change in relation to physical activity.
Trial Design: Phase III: A pragmatic factorial design randomised controlled to assess the effectiveness of a prehabilitation programme delivered prior to cancer treatments and/or major cancer surgery in patients undergoing elective intra-cavity major cancer surgery in Wessex.
Sample size: 1560
Intervention:
- An in-hospital transition to a community based Structured Responsive Exercise-Training Programme (SRETP) ± psychological support (delivered in community/ council gyms or Cancer Support Centers). The intervention/s will be delivered before surgery. Patients receiving neoadjuvant cancer treatments prior to surgery will receive the intervention during and after these treatments.
- Control: Standard care with extra monitoring
- Conditions
- Cancer
- Being tested
- SRETP, Psychological support
- Keywords
- Exercise, mortality, morbidity, surgery, colorectal, upper gastrointestinal, hepatobiliary, urology, lung, nutrition, psychology
- 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.
SRETPBehavioural
SRETP will involve short periods of exercise at a high intensity interspersed with short periods of exercise at a moderate intensity (aerobic interval training). We will also include resistance training in each session. Exercise intensities during the interval exercise-training program are specific to each patient and derived from CPET. Moderate intensity exercise is below the anaerobic threshold (AT). Patients will exercise at 80% of oxygen uptake (VO2) obtained at the anaerobic threshold (80%AT) for moderate intensity exercise - 3 minutes. Severe exercise intensity is recognised as 50% of the difference between the VO2 AT and VO2 Peak (50%∆) - 2 minutes.
Psychological supportBehavioural
Support sessions will be patient-centred, giving the patient an opportunity to raise any issues/concerns they are having, this may include (but will not be limited to) ways of coping with their reactions to cancer, family and relationship issues, exploring personal issues and dealing with practical issues. Patients will have access to other resources available at the cancer centres including but not restricted to further information about their condition and how to access financial support. These processes reflect the best practice currently being delivered by cancer support centre staff in the Wessex region. Any patient deemed at risk (i.e. from suicidal ideation or self harm) will be reported to their GP, followed up by a letter.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual care plus additional monitoring |
| SRETP | Experimental | Structured Responsive Exercise Training Programme (SRETP) prior to surgery Receives: Behavioral: SRETP |
| Psychological support | Experimental | Psychological support prior to surgery Receives: Behavioral: Psychological support |
| SRETP and psychological support | Experimental | Structured Responsive Exercise Training Programme (SRETP) and psychological support prior to surgery Receives: Behavioral: SRETP; Behavioral: Psychological support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative length of hospital stay
Date of hospital admission minus date of discharge would equal length of post-operative stay (LOS).
Measured: up to 1 year
Secondary outcomes (43)
Change in objectively measured cardiopulmonary exercise testing variables - Oxygen uptake at anaerobic threshold (ml/kg/min) and oxygen uptake at peak exercise (ml/kg/min)
Change in cardiopulmonary exercise variables i.e. oxygen uptake (VO2) at anaerobic threshold (AT) and at peak exercise. A clinically significant difference in physical fitness is defined as ≥ 2ml/min/kg VO2 at AT.
Measured: up to 15 weeks
Overall survival - 1
Overall survival at 1 year post surgery
Measured: 1 year post-operatively
Overall survival -2
Overall survival at 5 year post surgery
Measured: 5 years post-operatively
Disease free survival
Clinical or radiologically measured disease free survival
Measured: 1 year post-operatively
Post-operative morbidity -1
Patients post-operative morbidity survey (POMS) will be characterised on day 3, 5, 7 and 15. The POMS 18-item survey will be used to address nine domains of postoperative morbidity (pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, wound complication, haematological and pain).
Measured: POMS at day 3,5,7 and 15.
Post-operative morbidity -2
On day of discharge, patient's surgical complications (if any) will be graded using the Clavien-Dindo classification of surgical complications This classification is used to assess overall hospital morbidity following surgical procedures. Patients are graded as 0 (no complications) or Grade I-V based on the level of complication, including the number of organ system involvement. Grade V is defined as death of a patient. A record of the Comprehensive Complication Index (CCI) - an update of the Clavien-Dindo classification will also be collected
Measured: up to 1 year
Physical activity -1
Number of steps while active using a triaxial accelerometer eg. Senseware
Measured: Baseline up to 1 year post-operatively
Physical activity -2
sleep efficiency using a triaxial accelerometer eg. Senseware
Measured: Baseline up to 1 year post-operatively
Physical activity -3
metabolic equivalents using a triaxial accelerometer eg. Senseware
Measured: Baseline up to 1 year post-operatively
Physical activity -4
Godin Leisure Time and Exercise questionnaire - A self-reported measure of physical activity
Measured: Baseline up to 1 year post-operatively
Health related quality of life -1
Changes in health related quality of life measurements using validated questionnaires; including:
EQ-5D-5L is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care as well as in population health surveys
Measured: Baseline up to 1 year post-operatively
Health related quality of life -2
Changes in health related quality of life measurements using validated questionnaires; including:
Cancer specific quality of life will be measured using the EORTC-QLQ-C30.
Measured: Baseline up to 1 year post-operatively
Health related quality of life -3
Changes in health related quality of life measurements using validated semi-structured interview techniques
Measured: Baseline up to 1 year post-operatively
Mental well being -1
Self-efficacy (confidence) to self-manage chronic disease (SEMCD), measured using the Lorig SEMCD scale
A confidence scale that represents the patients confidence that a regular task can be achieved. 1 = Not confident at all and 10= totally confident.
Measured: Baseline up to 1 year post-operatively
Mental well being -2
Patients knowledge skills and confidence to manage their own health and care will be measured using the Patient Activation Measure (PAM)
Agreement or disagreement with statements. Choice between disagree strongly, disagree, agree, agree strongly and not applicable
Measured: Baseline up to 1 year post-operatively
Mental well being -3
Anxiety and depression will be measured using the Hospital Anxiety and Depression Scale (HADS)
A tick box questionnaire relating to anxieties and depression that a patient might have felt over the past week. Choices are most of the time, a lot fo the time, from time to time, and not at all for most questions.
Measured: Baseline up to 1 year post-operatively
Mental well being -4
Resilience, measured using the Connor-Davidson Resilience Scale (CD-RISC2)
Patients are asked to choose "x" in a box that best indicates how much they agree with the following statements resilience over the past month.
Options are not at all true; rarely true; sometimes true; often true; true nearly all of the time
Measured: Baseline up to 1 year post-operatively
Mental well being -5
Brief illness perception questionnaire (B-IPQ) - A self- reported nine-item scale designed to rapidly assess the cognitive and emotional representations of illness by a questionnaire.
Various illness questions are asked and the patient picks a number from 0 to 10; 0= no affect at all and 10= severely affects my life.
Measured: Baseline up to 1 year post-operatively
Complex health interventions evaluation
Medical research council (MRC) RE-AIM reporting
Measured: Baseline up to 1 year post-operatively
Radiological markers of sarco-cachexia measured from routine CT scans
CT, MRI, PET CT full report from radiologist including TNM stage, venous invasion, resection margin involvement, tumour metabolic activity, RECIST staging and any other cancer pathway specific staging/restaging test. Raw DICOM files from radiological softwares or via the PACS team will be downloaded securely to measure radiological markers of sarco-cachexia.
Measured: Baseline up to 1 year post-operatively
Toxicity and adverse events
Neoadjuvant cancer therapy induced toxicity measured using the CTC AE v4
Measured: Baseline up to 1 year post-operatively
Tumour outcomes -1
Radiology - CT, MRI, PET CT - Tumour Node Metastasis (TNM v7) stage
Measured: Baseline up to 1 year post-operatively
Tumour outcomes -2
Radiology - CT, MRI, PET CT full report from radiologist mainly including venous invasion
Measured: Baseline up to 1 year post-operatively
Tumour outcomes -3
Radiology - CT, MRI, PET CT full report from radiologist mainly including resection margin involvement
Measured: Baseline up to 1 year post-operatively
Tumour outcomes -4
Radiology - CT, MRI, PET CT full report from radiologist mainly including tumour metabolic activity
Measured: Baseline up to 1 year post-operatively
Tumour outcomes -5
Radiology - CT, MRI, PET CT full report from radiologist mainly including RECIST staging
Measured: Baseline up to 1 year post-operatively
Tumour outcomes -6
Radiology - CT, MRI, PET CT full report from radiologist mainly including tumour regression score
Measured: Baseline up to 1 year post-operatively
Tumour outcomes -7
Histopathology - TNM score version 7
Measured: Baseline up to 1 year post-operatively
Tumour outcomes -8
Histopathology - differentiation grading using TNM version 7
Measured: Baseline up to 1 year post-operatively
Tumour outcomes -9
Histopathology - extramural tumour extension using TNM version 7
Measured: Baseline up to 1 year post-operatively
Tumour outcomes -10
Histopathology - lymphovascular invasion using TNM version 7
Measured: Baseline up to 1 year post-operatively
Tumour outcomes -11
Histopathology - perineural invasion using TNM version 7
Measured: Baseline up to 1 year post-operatively
Tumour outcomes -12
Histopathology - venous invasion using TNM version 7
Measured: Baseline up to 1 year post-operatively
Tumour outcomes -13
Histopathology -resection margin status using TNM version 7
Measured: Baseline up to 1 year post-operatively
Tumour outcomes -14
Histopathology - tumour regression grading (TRG/ Mandard Score)
Measured: Baseline up to 1 year post-operatively
Tumour outcomes -15
Histopathology -lymph node status using TNM version 7
Measured: Baseline up to 1 year post-operatively
Tumour outcomes -16
Histopathology - number of lymph nodes involved using TNM version 7
Measured: Baseline up to 1 year post-operatively
Disability adjusted survival
WHODAS v2.0 will ask patients to rate whether their health condition has had impact upon them in regards to 7 disability and functionality domains (understanding and communicating, getting around, self-care, getting along with others, life activities: household, life activities: work/school, and participation in society). This includes a measure of cost effectiveness.
Measured: Baseline up to 1 year post-operatively
Tumour microenvironment
Endoscopic and surgical paired tumour biopsies will be taken as part of the oesophageal cancer clinical and molecular stratification study (OCCAMS) if the patient has been consented to the bio-banking study. Endoscopic and surgical paired tumour biopsies will be taken as part of TARGET LUNG study if the patient has been consented to the bio-banking study. Other tumor types will be banked in centers taking part in the International Cancer Genome Consortium. Clinical cancer pathway pathological samples embedded in paraffin and used in routine clinical practice may also be requested at a later stage for tumour analyses.
Tumour biopsy +/- at endoscopic ultrasound (pre Cancer treatments and upon diagnosis) and at surgery (where possible depending on availability at site and cancer cohort)
Measured: Baseline up to 1 year post-operatively
Nutrition -1
Height (cms) and weight (kg) will be combined to report BMI in kg/m^2
Measured: Baseline up to 1 year post-operatively
Nutrition -2
Patient Reported Experience Measures (PREMS) including symptom and appetite questionnaires (Council of Nutrition Appetite Questionnaire- CNAQ) (in My Medical Record as part of standard clinical care)
Measured: Baseline up to 1 year post-operatively
Nutrition -3
Patient self-completing online assessment (myFood24 incorporated in My Medical Record)
Measured: Baseline up to 1 year post-operatively
Nutrition -4
Malnutrition Universal Screening Tool as part of standard clinical care
Measured: Baseline up to 1 year post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start26 Mar 2018
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2 factorial design randomised controlled interventional trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, Portsmouth Hospitals NHS Trust, Hampshire Hospitals NHS Foundation Trust, Poole Hospital NHS Foundation Trust, Isle of Wight NHS Trust, Dorset County Hospital NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Samantha Leggett, Study director, University Hospitals Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509428
- Sponsor's protocol ID
- RHM CRI 0360
- Acronym
- WesFit
- Status last verified
- May 2019
- First submitted
- 7 Mar 2018
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
West M, Bates A, Grimmett C, Allen C, Green R, Hawkins L, Moyses H, Leggett S, Z H Levett D, Rickard S, Varkonyi-Sepp J, Williams F, Wootton S, Hayes M, P W Grocott M, Jack S. The Wessex Fit-4-Cancer Surgery Trial (WesFit): a protocol for a factorial-design, pragmatic randomised-controlled trial investigating the effects of a multi-modal prehabilitation programme in patients undergoing elective major intra-cavity cancer surgery. F1000Res. 2021 Sep 21;10:952. doi: 10.12688/f1000research.55324.2. eCollection 2021.
PubMed 36247802
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Factorial Design Randomised Controlled Study to Assess the Efficacy of the Implementation of a Prehabilitation Programme in Patients Undergoing Elective Major Intra - Cavity Cancer Surgery in Wessex
- ClinicalTrials.gov ID
- NCT03509428
- Acronym / sponsor ID
- WesFit / RHM CRI 0360
- Conditions
- Cancer
- Keywords
- Exercise, mortality, morbidity, surgery, colorectal, upper gastrointestinal, hepatobiliary, urology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,560 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, Portsmouth Hospitals NHS Trust, Hampshire Hospitals NHS Foundation Trust, Poole Hospital NHS Foundation Trust, Isle of Wight NHS Trust, Dorset County Hospital NHS Foundation Trust
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 26 Apr 2018 (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.
Trial Phase: Phase III: A multi-centre efficacy pragmatic factorial design randomised controlled trial with patient informed development and process evaluation
Indication: Patients undergoing major electively resectable intra - cavity cancer surgery with or without neoadjuvant cancer treatments (including chemotherapy (NAC), chemoradiotherapy (CRT), or immunotherapy).
Objective: To investigate the efficacy of a community based Structured Responsive Exercise-training Programme (SRETP) ± psychological support on surgical outcome by reducing postoperative length of stay (LOS) and complications.
Secondary Objective:
To investigate the efficacy of a community based Structured Responsive Exercise-training Programme (SRETP) ± psychological support to improve disease-free overall survival. Cardiopulmonary Exercise test (CPET) variables, physical activity, morbidity, radiological markers of sarcopenia, toxicity, tumour down-staging, tumour regression, disability adjusted survival (WHODAS) overall survival and quality of life (QoL).
Detailed description
Rationale: Fitter patients have better surgical outcomes. Poor physical fitness measured objectively using cardiopulmonary exercise testing has been associated with increased LOS, increased morbidity and mortality in many patient cohorts undergoing major cancer surgery. Chemotherapy and radiotherapy have detrimental effects on physical fitness, which may in turn have a detrimental effect on the patients' ability to withstand surgery. Research suggests psychological factors including depression and self-efficacy (confidence to manage cancer-related problems) prior to surgery predict recovery trajectories in health-related quality of life up to 2 years after major surgery for colorectal cancer.
The aim is to investigate whether SRETP (Prehabilitation) ± psychological support prior to and during cancer treatment before major elective surgery reduces LOS, increases survival and improves their ability to self manage. Additionally, we aim to see if this intervention can bring about long-term behavioural change in relation to physical activity.
Trial Design: Phase III: A pragmatic factorial design randomised controlled to assess the effectiveness of a prehabilitation programme delivered prior to cancer treatments and/or major cancer surgery in patients undergoing elective intra-cavity major cancer surgery in Wessex.
Sample size: 1560
Intervention:
- An in-hospital transition to a community based Structured Responsive Exercise-Training Programme (SRETP) ± psychological support (delivered in community/ council gyms or Cancer Support Centers). The intervention/s will be delivered before surgery. Patients receiving neoadjuvant cancer treatments prior to surgery will receive the intervention during and after these treatments.
- Control: Standard care with extra monitoring
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 2x2 factorial design randomised controlled interventional trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual care plus additional monitoring |
| SRETP | Experimental | Behavioral: SRETPStructured Responsive Exercise Training Programme (SRETP) prior to surgery |
| Psychological support | Experimental | Behavioral: Psychological supportPsychological support prior to surgery |
| SRETP and psychological support | Experimental | Behavioral: SRETP, Behavioral: Psychological supportStructured Responsive Exercise Training Programme (SRETP) and psychological support prior to surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients
- aged over 18 years old
- scheduled to have major intra-cavity cancer surgery with a curative intent, defined as thoracic, colorectal, oesophagogastric, urological and hepatobiliary (inc. pancreatic).
- surgery alone (unimodal)
- surgery combined (multimodal) with cancer treatments (neoadjuvant chemotherapy, chemoradiotherapy or immunotherapies).
Key exclusion criteria (8 listed)
- Patients will be excluded if under the age of 18 years,
- if their tumour is considered surgically non- resectable,
- having absolute or relative contraindications to completing a CPET,
- patients are unable to perform CPET due to other coexisting acute illness or conditions (e.g. lower limb dysfunction),
- patients decline surgery,
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 |
|---|---|---|
| SRETPSRETP will involve short periods of exercise at a high intensity interspersed with short periods of exercise at a moderate intensity (aerobic interval training). We will also include resistance training in each session. Exercise intensities during the interval exercise-training program are specific to each patient and derived from CPET. Moderate intensity exercise is below the anaerobic threshold (AT). Patients will exercise at 80% of oxygen uptake (VO2) obtained at the anaerobic threshold (80%AT) for moderate intensity exercise - 3 minutes. Severe exercise intensity is recognised as 50% of the difference between the VO2 AT and VO2 Peak (50%∆) - 2 minutes. | Behavioural | SRETP, SRETP and psychological support |
| Psychological supportSupport sessions will be patient-centred, giving the patient an opportunity to raise any issues/concerns they are having, this may include (but will not be limited to) ways of coping with their reactions to cancer, family and relationship issues, exploring personal issues and dealing with practical issues. Patients will have access to other resources available at the cancer centres including but not restricted to further information about their condition and how to access financial support. These processes reflect the best practice currently being delivered by cancer support centre staff in the Wessex region. Any patient deemed at risk (i.e. from suicidal ideation or self harm) will be reported to their GP, followed up by a letter. | Behavioural | Psychological support, SRETP and psychological support |
Primary outcome
Post-operative length of hospital stay
Time frame: up to 1 year
Date of hospital admission minus date of discharge would equal length of post-operative stay (LOS).
43 secondary outcomes
Change in objectively measured cardiopulmonary exercise testing variables - Oxygen uptake at anaerobic threshold (ml/kg/min) and oxygen uptake at peak exercise (ml/kg/min)
Time frame: up to 15 weeks
Overall survival - 1
Time frame: 1 year post-operatively
Overall survival -2
Time frame: 5 years post-operatively
Disease free survival
Time frame: 1 year post-operatively
Post-operative morbidity -1
Time frame: POMS at day 3,5,7 and 15.
Post-operative morbidity -2
Time frame: up to 1 year
Physical activity -1
Time frame: Baseline up to 1 year post-operatively
Physical activity -2
Time frame: Baseline up to 1 year post-operatively
Physical activity -3
Time frame: Baseline up to 1 year post-operatively
Physical activity -4
Time frame: Baseline up to 1 year post-operatively
Health related quality of life -1
Time frame: Baseline up to 1 year post-operatively
Health related quality of life -2
Time frame: Baseline up to 1 year post-operatively
Health related quality of life -3
Time frame: Baseline up to 1 year post-operatively
Mental well being -1
Time frame: Baseline up to 1 year post-operatively
Mental well being -2
Time frame: Baseline up to 1 year post-operatively
Mental well being -3
Time frame: Baseline up to 1 year post-operatively
Mental well being -4
Time frame: Baseline up to 1 year post-operatively
Mental well being -5
Time frame: Baseline up to 1 year post-operatively
Complex health interventions evaluation
Time frame: Baseline up to 1 year post-operatively
Radiological markers of sarco-cachexia measured from routine CT scans
Time frame: Baseline up to 1 year post-operatively
Toxicity and adverse events
Time frame: Baseline up to 1 year post-operatively
Tumour outcomes -1
Time frame: Baseline up to 1 year post-operatively
Tumour outcomes -2
Time frame: Baseline up to 1 year post-operatively
Tumour outcomes -3
Time frame: Baseline up to 1 year post-operatively
Tumour outcomes -4
Time frame: Baseline up to 1 year post-operatively
Tumour outcomes -5
Time frame: Baseline up to 1 year post-operatively
Tumour outcomes -6
Time frame: Baseline up to 1 year post-operatively
Tumour outcomes -7
Time frame: Baseline up to 1 year post-operatively
Tumour outcomes -8
Time frame: Baseline up to 1 year post-operatively
Tumour outcomes -9
Time frame: Baseline up to 1 year post-operatively
Tumour outcomes -10
Time frame: Baseline up to 1 year post-operatively
Tumour outcomes -11
Time frame: Baseline up to 1 year post-operatively
Tumour outcomes -12
Time frame: Baseline up to 1 year post-operatively
Tumour outcomes -13
Time frame: Baseline up to 1 year post-operatively
Tumour outcomes -14
Time frame: Baseline up to 1 year post-operatively
Tumour outcomes -15
Time frame: Baseline up to 1 year post-operatively
Tumour outcomes -16
Time frame: Baseline up to 1 year post-operatively
Disability adjusted survival
Time frame: Baseline up to 1 year post-operatively
Tumour microenvironment
Time frame: Baseline up to 1 year post-operatively
Nutrition -1
Time frame: Baseline up to 1 year post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
- Derived from this study: PubMed 36247802West M, Bates A, Grimmett C, Allen C, Green R, Hawkins L, Moyses H, Leggett S, Z H Levett D, Rickard S, Varkonyi-Sepp J, Williams F, Wootton S, Hayes M, P W Grocott M, Jack S. The Wessex Fit-4-Cancer Surgery Trial (WesFit): a protocol for a factorial-design, pragmatic randomised-controlled trial investigating the effects of a multi-modal prehabilitation programme in patients undergoing elective major intra-cavity cancer surgery. F1000Res. 2021 Sep 21;10:952. doi: 10.12688/f1000research.55324.2. eCollection 2021.
- Individual participant dataSharing planned: No
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Samantha Leggett study director
University Hospitals Southampton NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SRETP and Psychological support in people with Cancer, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
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 8 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: status not confirmed, as of the sponsor's last update on 9 May 2019. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandy Jack, PhD (023 81205308, s.jack@soton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative length of hospital stay (time frame: up to 1 year). 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 NCT03509428, which also lists 1 linked publication.
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 9 May 2019.