Cancer Clinical Trial
— WesFitOfficial 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).
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).
Status | Recruiting |
Enrollment | 1560 |
Est. completion date | March 1, 2022 |
Est. primary completion date | March 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hopsitals Southampton | Southampton |
Lead Sponsor | Collaborator |
---|---|
University Hospital Southampton NHS Foundation Trust | Dorset County Hospital NHS Foundation Trust, Hampshire Hospitals NHS Foundation Trust, Isle of Wight NHS Trust, Poole Hospital NHS Foundation Trust, Portsmouth Hospitals NHS Trust, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-operative length of hospital stay | Date of hospital admission minus date of discharge would equal length of post-operative stay (LOS). | up to 1 year | |
Secondary | 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. | up to 15 weeks | |
Secondary | Overall survival - 1 | Overall survival at 1 year post surgery | 1 year post-operatively | |
Secondary | Overall survival -2 | Overall survival at 5 year post surgery | 5 years post-operatively | |
Secondary | Disease free survival | Clinical or radiologically measured disease free survival | 1 year post-operatively | |
Secondary | 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). | POMS at day 3,5,7 and 15. | |
Secondary | 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 | up to 1 year | |
Secondary | Physical activity -1 | Number of steps while active using a triaxial accelerometer eg. Senseware | Baseline up to 1 year post-operatively | |
Secondary | Physical activity -2 | sleep efficiency using a triaxial accelerometer eg. Senseware | Baseline up to 1 year post-operatively | |
Secondary | Physical activity -3 | metabolic equivalents using a triaxial accelerometer eg. Senseware | Baseline up to 1 year post-operatively | |
Secondary | Physical activity -4 | Godin Leisure Time and Exercise questionnaire - A self-reported measure of physical activity | Baseline up to 1 year post-operatively | |
Secondary | 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 |
Baseline up to 1 year post-operatively | |
Secondary | 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. |
Baseline up to 1 year post-operatively | |
Secondary | Health related quality of life -3 | Changes in health related quality of life measurements using validated semi-structured interview techniques | Baseline up to 1 year post-operatively | |
Secondary | 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. |
Baseline up to 1 year post-operatively | |
Secondary | 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 |
Baseline up to 1 year post-operatively | |
Secondary | 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. |
Baseline up to 1 year post-operatively | |
Secondary | 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 |
Baseline up to 1 year post-operatively | |
Secondary | 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. |
Baseline up to 1 year post-operatively | |
Secondary | Complex health interventions evaluation | Medical research council (MRC) RE-AIM reporting | Baseline up to 1 year post-operatively | |
Secondary | 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. | Baseline up to 1 year post-operatively | |
Secondary | Toxicity and adverse events | Neoadjuvant cancer therapy induced toxicity measured using the CTC AE v4 | Baseline up to 1 year post-operatively | |
Secondary | Tumour outcomes -1 | Radiology - CT, MRI, PET CT - Tumour Node Metastasis (TNM v7) stage | Baseline up to 1 year post-operatively | |
Secondary | Tumour outcomes -2 | Radiology - CT, MRI, PET CT full report from radiologist mainly including venous invasion | Baseline up to 1 year post-operatively | |
Secondary | Tumour outcomes -3 | Radiology - CT, MRI, PET CT full report from radiologist mainly including resection margin involvement | Baseline up to 1 year post-operatively | |
Secondary | Tumour outcomes -4 | Radiology - CT, MRI, PET CT full report from radiologist mainly including tumour metabolic activity | Baseline up to 1 year post-operatively | |
Secondary | Tumour outcomes -5 | Radiology - CT, MRI, PET CT full report from radiologist mainly including RECIST staging | Baseline up to 1 year post-operatively | |
Secondary | Tumour outcomes -6 | Radiology - CT, MRI, PET CT full report from radiologist mainly including tumour regression score | Baseline up to 1 year post-operatively | |
Secondary | Tumour outcomes -7 | Histopathology - TNM score version 7 | Baseline up to 1 year post-operatively | |
Secondary | Tumour outcomes -8 | Histopathology - differentiation grading using TNM version 7 | Baseline up to 1 year post-operatively | |
Secondary | Tumour outcomes -9 | Histopathology - extramural tumour extension using TNM version 7 | Baseline up to 1 year post-operatively | |
Secondary | Tumour outcomes -10 | Histopathology - lymphovascular invasion using TNM version 7 | Baseline up to 1 year post-operatively | |
Secondary | Tumour outcomes -11 | Histopathology - perineural invasion using TNM version 7 | Baseline up to 1 year post-operatively | |
Secondary | Tumour outcomes -12 | Histopathology - venous invasion using TNM version 7 | Baseline up to 1 year post-operatively | |
Secondary | Tumour outcomes -13 | Histopathology -resection margin status using TNM version 7 | Baseline up to 1 year post-operatively | |
Secondary | Tumour outcomes -14 | Histopathology - tumour regression grading (TRG/ Mandard Score) | Baseline up to 1 year post-operatively | |
Secondary | Tumour outcomes -15 | Histopathology -lymph node status using TNM version 7 | Baseline up to 1 year post-operatively | |
Secondary | Tumour outcomes -16 | Histopathology - number of lymph nodes involved using TNM version 7 | Baseline up to 1 year post-operatively | |
Secondary | 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. | Baseline up to 1 year post-operatively | |
Secondary | 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) |
Baseline up to 1 year post-operatively | |
Secondary | Nutrition -1 | Height (cms) and weight (kg) will be combined to report BMI in kg/m^2 | Baseline up to 1 year post-operatively | |
Secondary | 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) | Baseline up to 1 year post-operatively | |
Secondary | Nutrition -3 | Patient self-completing online assessment (myFood24 incorporated in My Medical Record) | Baseline up to 1 year post-operatively | |
Secondary | Nutrition -4 | Malnutrition Universal Screening Tool as part of standard clinical care | Baseline up to 1 year post-operatively |
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