Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-25 @ 11:49 PM
Study NCT ID:
NCT05547594
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2022-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prehabilitation in Patients With Cancer and Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-24', 'studyFirstSubmitDate': '2022-09-12', 'studyFirstSubmitQcDate': '2022-09-15', 'lastUpdatePostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hospital length of stay', 'timeFrame': '8 weeks after surgery', 'description': 'Number of days spent in the hospital after surgery'}, {'measure': '90-day readmission', 'timeFrame': '90 days after surgery', 'description': 'Number of readmissions during the 90 days after surgery'}, {'measure': 'Postsurgical complications', 'timeFrame': '6 months after surgery', 'description': 'Number of complications after surgery'}], 'primaryOutcomes': [{'measure': 'Changes in Short Physical Performance Battery (SPPB) at different time points from baseline to 1 year after surgery', 'timeFrame': 'upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery', 'description': 'Group of measures that combines the results of the gait speed, chair stand and balance tests, with scores ranging from 0 (worst performance) to 12 (best performance).'}], 'secondaryOutcomes': [{'measure': 'Changes in fasting glucose at different time points from baseline to 1 year after surgery', 'timeFrame': 'upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery', 'description': 'Blood fasting glucose obtained via finger prick'}, {'measure': 'Changes in fasting insulin at different time points from baseline to 1 year after surgery', 'timeFrame': 'upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery', 'description': 'Blood fasting insulin obtained via finger prick'}, {'measure': 'Changes in BMI at different time points from baseline to 1 year after surgery', 'timeFrame': 'upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery', 'description': 'Body mass index'}, {'measure': 'Changes in waist circumference at different time points from baseline to 1 year after surgery', 'timeFrame': 'upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery', 'description': 'Waist circumference'}, {'measure': 'Changes in hip circumference at different time points from baseline to 1 year after surgery', 'timeFrame': 'upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery', 'description': 'Hip circumferences'}, {'measure': 'Changes in Patient Health Questionnaire-9 (PHQ-9) at different time points from baseline to 1 year after surgery', 'timeFrame': 'upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery', 'description': 'Self-administered questionnaires to assess depression severity, with scores ranging from 0 (no depression) to 27 (severe depression)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer', 'Type 2 diabetes', 'surgery', 'prehabilitation', 'recovery', 'exercise', 'nutrition', 'protein', 'anxiety', 'quality of life', 'physical performance'], 'conditions': ['Cancer', 'Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '34204531', 'type': 'RESULT', 'citation': 'Wu F, Rotimi O, Laza-Cagigas R, Rampal T. The Feasibility and Effects of a Telehealth-Delivered Home-Based Prehabilitation Program for Cancer Patients during the Pandemic. Curr Oncol. 2021 Jun 17;28(3):2248-2259. doi: 10.3390/curroncol28030207.'}]}, 'descriptionModule': {'briefSummary': "Surgical prehabilitation refers to pre-operative interventions aimed at increasing patients' physiological reserve so that they can better cope with the stress of surgery, avoid post-operative complications and have a faster recovery after surgery. Multimodal prehabilitation combines different aspects related to a healthy lifestyle including but not limited to; physical activity, nutritional education, anxiety coping strategies, alcohol moderation and smoking cessation. Although these aspects are well known, having a cancer diagnosis and the likelihood of an incoming operation during the weeks after diagnosis, place patients in a situation where they may be more receptive to adopting lifestyle changes aimed at promoting health. Such changes could be incorporated, not just in the short-term in preparation for surgery, but also in the medium- and long-term, improving patients' wellbeing and potentially reducing the risk of cancer reoccurrence and other diseases.\n\nAlthough the benefits of prehabilitation before surgery are understood, the effects it may have in non-insulin-dependent Type 2 diabetes patients are unknown.\n\nThis project aims to: (i) Analyse the effects of a multimodal prehabilitation programme vs. the current National Health Service (NHS) standard approach, on physical performance in cancer patients with non-insulin-dependent Type 2 diabetes prior to surgery. (ii) Explore the impact of the programme on body composition and metabolic markers. (iii) Analyse the programme adherence, markers of well-being and quality of life during a post-surgery period of up to 12 months as well as its effects on clinical outcomes.", 'detailedDescription': "This study will take advantage of already existing infrastructures, by approaching a single National Health Service (NHS) hospital in England that is already run a prehabilitation service for its patients. This study will analyse the effect of the prehabilitation programme on a specific group of patients, those with cancer and Type 2 diabetes who do not require insulin as part of their diabetes treatment and who are waiting for surgery.\n\nSurgical prehabilitation refers to interventions done before surgery to increase the patient's overall health and fitness so that they can better cope with the stress of surgery, avoid complications/reduce, and have a faster recovery after surgery. Multimodal prehabilitation combines different aspects related to a healthy lifestyle, including but not limited to; physical activity, nutritional education, anxiety coping strategies, alcohol moderation and smoking cessation.\n\nMultimodal prehabilitation programmes may use a combination of telehealth and face-to-face delivery to provide flexibility according to the preferences of the patients.\n\nThe collaboration between the University of Greenwich and NHS will provide an opportunity to measure the impact of the programme on those participants with Type 2 diabetes, beyond variables like weight and fasting blood glucose (i.e., body composition, glycaemic behaviour, blood insulin concentration, immune system markers…).\n\nThe hospital prehabilitation team will identify potential study participants (patients with Type 2 diabetes who do not use insulin awaiting surgery) amongst those referred to their service. The prehabilitation team will present the idea of the study to the potential participants and will ask for consent to share their contact details with the sponsor. If consent is received, the researcher will contact them to briefly present to them the possibility of joining the study. This 1st contact will be overseen by the Chief Investigator.\n\nThose who accept to participate in the study will be allocated into 2 different groups. Patients undergoing prehabilitation will join the prehabilitation group of the study, while those declining prehabilitation will join the control group.\n\nRegardless of the group, all patients will undergo the same number of interactions with the researcher:\n\n1. Interview and consent The candidate will be provided with the patient information sheet and explained what they can expect and what will be expected from them if they decide to participate in the study. Candidates will be able to ask questions and, in case they decide to participate, they will sign the participant consent form.\n2. Baseline/initial assessment The participant will undergo a number of tests/measurements/questionnaires to obtain information on their physical performance quality of life, body composition, glycaemic markers and immune system markers.\n\n This assessment will take place a few weeks before surgery before the patient starts prehabilitation (prehab group) or upon joining the study (control group).\n3. Assessment before surgery The participant will undergo a number of tests/measurements/questionnaires to obtain information on their physical performance quality of life, body composition, glycaemic markers and immune system markers.\n\n This assessment will take place a few days before surgery.\n4. Assessment 6 weeks after surgery The participant will undergo a number of tests/measurements/questionnaires to obtain information on their physical performance quality of life, body composition, glycaemic markers and immune system markers.\n\n This assessment will take place 6 weeks after surgery, a time that generally allows the participant to recover enough to be able to move around comfortably and perform some light physical activity\n5. Assessment 6 months after surgery The participant will undergo a number of tests/measurements/questionnaires to obtain information on their physical performance quality of life, body composition, glycaemic markers and immune system markers.\n\n This assessment will take place 6 months after surgery, a time by which the patient will generally be fully recovered, potentially reaching their pre-surgical status, and will have been able to resume their regular day-to-day activity\n6. Assessment 12 months after surgery The participant will undergo a number of tests/measurements/questionnaires to obtain information on their physical performance quality of life, body composition, glycaemic markers and immune system markers.\n\nBoth groups (prehabilitation and control) will undergo the same previously described assessments. This will allow us to understand and compare how the measured variables change through time in both groups (prehabilitation vs control).\n\nThe investigators hypothesise that prehabilitation will improve patients' physical performance prior to surgery and will provide them with a range of tools to help them recover faster and manage their overall health better (including their diabetes control) for at least one year after surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Capacity to give consent\n* Newly diagnosed with cancer\n* Non-insulin-dependent Type 2 diabetes\n* Awaiting surgery for cancer\n\nExclusion Criteria:\n\n* Medical contraindication to engage in physical activity'}, 'identificationModule': {'nctId': 'NCT05547594', 'briefTitle': 'Prehabilitation in Patients With Cancer and Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Greenwich'}, 'officialTitle': 'Impact of a Multimodal Prehabilitation Programme on Markers of Health, Quality of Life and the Short and Long Post-surgery Recovery Period in Cancer Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'UoG_2022_CT2D_Prehab'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prehabilitation', 'description': 'Arm undergoing multimodal prehabilitation (physical activity, nutritional education and anxiety management) during the weeks leading up to surgery', 'interventionNames': ['Behavioral: Multimodal surgical prehabilitation']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'Arm receiving standard of care (no prehabilitation)'}], 'interventions': [{'name': 'Multimodal surgical prehabilitation', 'type': 'BEHAVIORAL', 'description': 'Participants will be encouraged to engage in regular physical activity (endurance and resistance exercise), eat healthily and undergo cognitive behavioural therapy (the latter only if required) during the weeks prior to surgery.', 'armGroupLabels': ['Prehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE9 2BT', 'city': 'Eltham', 'state': 'England', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Fernando Naclerio, PhD', 'role': 'CONTACT', 'email': 'f.j.naclerio@greenwich.ac.uk', 'phone': '0044 2083 318441'}, {'name': 'Roberto Laza-Cagigas, MSc', 'role': 'CONTACT', 'email': 'r.lazacagigas@greenwich.ac.uk', 'phone': '0044 7597 058406'}, {'name': 'Ian Swaine, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marcos Seijo, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Roberto Laza-Cagigas, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'School of Human Sciences, University of Greenwich, Avery Hill Campus, Sparrows Farm (Office SF112B)', 'geoPoint': {'lat': 51.45061, 'lon': 0.05225}}, {'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Roberto Laza, PhD/MPhil', 'role': 'CONTACT', 'email': 'R.LazaCagigas@greenwich.ac.uk'}], 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Fernando Naclerio, PhD', 'role': 'CONTACT', 'email': 'f.j.naclerio@greenwich.ac.uk', 'phone': '0044 2083 318441'}, {'name': 'Roberto Laza-Cagigas, MSc', 'role': 'CONTACT', 'email': 'r.lazacagigas@greenwich.ac.uk', 'phone': '0044 7597 058406'}], 'overallOfficials': [{'name': 'Fernando Naclerio, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Greenwich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Greenwich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in Strength Training and Sports Nutrition', 'investigatorFullName': 'Fernando Naclerio', 'investigatorAffiliation': 'University of Greenwich'}}}}