Cancer Clinical Trial
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).
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).
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:
1. 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.
2. Control: Standard care with extra monitoring
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05346796 -
Survivorship Plan HEalth REcord (SPHERE) Implementation Trial
|
N/A | |
Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
Completed |
NCT04867850 -
Effect of Behavioral Nudges on Serious Illness Conversation Documentation
|
N/A | |
Enrolling by invitation |
NCT04086251 -
Remote Electronic Patient Monitoring in Oncology Patients
|
N/A | |
Completed |
NCT01285037 -
A Study of LY2801653 in Advanced Cancer
|
Phase 1 | |
Completed |
NCT00680992 -
Study of Denosumab in Subjects With Giant Cell Tumor of Bone
|
Phase 2 | |
Completed |
NCT00062842 -
Study of Irinotecan on a Weekly Schedule in Children
|
Phase 1 | |
Active, not recruiting |
NCT04548063 -
Consent Forms in Cancer Research: Examining the Effect of Length on Readability
|
N/A | |
Completed |
NCT04337203 -
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
|
N/A | |
Recruiting |
NCT04349293 -
Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways
|
N/A | |
Terminated |
NCT02866851 -
Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy
|
N/A | |
Active, not recruiting |
NCT05304988 -
Development and Validation of the EFT for Adolescents With Cancer
|
||
Completed |
NCT00340522 -
Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
|
||
Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
Completed |
NCT03109041 -
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
|
Phase 1 | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
Recruiting |
NCT06206785 -
Resting Energy Expenditure in Palliative Cancer Patients
|
||
Recruiting |
NCT05318196 -
Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
|