Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593639
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
Effect of Prehabilitation on Head and Neck Cancer Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Does Prehabilitation Be Able to Favorably Impact on the Pathway of Head and Neck Cancer Patients Candidate to Surgery or Chemoradiotherapy As Primary Treatment a Prospective Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HNCANCERFIT
Brief Summary:
The primary aim of the study is to investigate the feasibility of a prehabilitation program which consists of a set of strategies including physical activity nutritional support and psychological counseling carried out before and during cancer treatment for patients affected by head and neck tumors About 4 weeks before surgery or the start of curative chemo-radiotherapy the patient will begin the prehabilitation program which will continue in parallel throughout the duration of the treatment and for up to 2 weeks after its completion This prehabilitation program will include a combination of physical activity exercises nutritional counseling and psychological counseling sessions all of which will be individualized for each patient At the time of tumor diagnosis T0 after 4 weeks of prehabilitation and before the start of the planned treatment T1 2 weeks after the end of treatment T2 and after 6 months T3 the patient will undergo a medical visit to collect anthropometric data vital signs a 6-minute walk test and will complete a series of questionnaires aimed at assessing the risk of malnutrition the development of anxiety and depression and questionnaires to evaluate their quality of life Throughout the duration of the study ie up to T3 6 months after the end of cancer treatment the patient will wear an electronic watch provided by the study designed to measure vital signs the number of daily steps and the type and minutes of physical activity
Detailed Description:
Oncological prehabilitation is defined as the process within the care pathway that takes place between the moment of cancer diagnosis and the initiation of acute treatments Prehabilitation aims to improve physical emotional and cognitive health before the start of cancer therapy with the ultimate goal of preventing and reducing treatment-related comorbidities and mortality It has also proven effective in reducing the adverse events of cancer therapies during the active phase of treatment making it potentially useful at any stage of the care pathway for cancer patients The role of exercise nutrition and stress reduction in improving outcomes for cancer patients has long been recognized in surgical prehabilitation but the evidence for benefits in non-surgical cancer treatments is weaker due to fewer randomized clinical trials Improvements in muscle strength a reduction in cancer-related comorbidities eg dyspnea cardiotoxicity urinary incontinence and a positive impact on quality of life including social well-being and a reduction in anxiety depression and stress have been demonstrated However the literature regarding the role of multimodal prehabilitation in head and neck cancers is even weaker there is limited data on feasibility and effectiveness with most studies focusing on optimizing nutritional status in malnourished patients or improving dysphagia but lacking data from prospective clinical trials This study is designed as a prospective multicenter experimental non-randomized uncontrolled interventional trial The objectives are i to evaluate the feasibility of prehabilitation before and during curative treatment for patients with head and neck cancer ii to investigate the efficacy outcomes of prehabilitation iii to conduct a cost-effectiveness analysis of prehabilitation
Feasibility will be assessed by measuring patient acceptance adherence and satisfaction with the program To evaluate adherence to the physical activity intervention patients will be provided with wearable devices capable of measuring daily steps type and minutes of activity To evaluate adherence to nutritional support subjects will be asked to complete a food diary along with telephone interviews conducted by expert professionals Adherence to psychological support requires a combination of self-reported measures clinical evaluation and behavioral observation A patient will be considered adherent if they complete at least 80 of the assigned tasks The investigators will consider prehabilitation feasible if more than 50 of patients in the treatment group adhere to the program for the entire scheduled period To investigate the efficacy of the treatment validated questionnaires on quality of life and the patients health status will be administered Secondary endpoints will include the difference between questionnaire scores at the end versus the beginning of the intervention in terms of variables quantifying the response to cancer treatments and the patients physiological status It will also be possible to calculate both the cost-effectiveness and cost-utility balance of the intervention considering the difference between the intervention arm and the historical control arm in terms of quality-adjusted life years The activities carried out to achieve this objective will allow us to characterize the changes between the start and end of the intervention Any significant positive or negative variation between the start and end of the intervention will be considered a result
Feasibility will be assessed by measuring patient acceptance adherence and satisfaction with the program To evaluate adherence to the physical activity intervention patients will be provided with wearable devices capable of measuring daily steps type and minutes of activity To evaluate adherence to nutritional support subjects will be asked to complete a food diary along with telephone interviews conducted by expert professionals Adherence to psychological support requires a combination of self-reported measures clinical evaluation and behavioral observation A patient will be considered adherent if they complete at least 80 of the assigned tasks The investigators will consider prehabilitation feasible if more than 50 of patients in the treatment group adhere to the program for the entire scheduled period To investigate the efficacy of the treatment validated questionnaires on quality of life and the patients health status will be administered Secondary endpoints will include the difference between questionnaire scores at the end versus the beginning of the intervention in terms of variables quantifying the response to cancer treatments and the patients physiological status It will also be possible to calculate both the cost-effectiveness and cost-utility balance of the intervention considering the difference between the intervention arm and the historical control arm in terms of quality-adjusted life years The activities carried out to achieve this objective will allow us to characterize the changes between the start and end of the intervention Any significant positive or negative variation between the start and end of the intervention will be considered a result
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None