Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05722223
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2022-03-14
Brief Title:
Trimodal Prehabilitation in Pancreatic Cancer Patients Urdergoing Neoadjuvant Treatment
Sponsor:
Puerta de Hierro University Hospital
Organization:
Puerta de Hierro University Hospital
Study Overview
Official Title:
Trimodal Prehabilitation in Pancreatic Cancer Patients Candidate to Neoadjuvant Treatment A Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREPANC
Brief Summary:
Pancreatic cancer is a disease with a very poor prognosis and less than 10 of these patients live beyond 5 years from diagnosis Further it is expected to become the second leading cause of death in the coming years Today surgery remains the cornerstone in curing this disease but the addition of chemotherapy is needed to improve survival The impact of adjuvant treatment has been previously demonstrated and its efficacy is absolute However neoadjuvant chemotherapy pre-surgery improves the results after surgery achieving earlier stages and with better prognosis and would lead to better survival results Besides the moment of cancer diagnosis is a moment of special receptivity to change lifestyles teachable moment
Multimodal prehabilitation includes 1 physical exercise 2 nutritional and 3 psychological support The potential advantages of prehabilitation during neoadjuvant therapy would be 1 the possibility of achieving a better physical condition to face surgery 2 fewer postoperative complications 3 more likely to receive adjuvant treatment after surgery 4 better physical function at the end of treatments To date most studies have focused on lung and prostate cancer with a high prevalence of men in the series
This strategy has previously been explored showing that it is safe and feasible Loughney et al We have not identified any study of trimodal prehabilitation during neoadjuvant treatment and none that has integrated motivational strategies to maintain adherence
Patients during chemotherapy have perceived several adverse effects that could limit adherence to the program In this regard a review on the motivation and exercise in cancer survivors shows that it is necessary to apply theoretical frameworks to understand cognitive and motivational processes and develop educational interventions The self-determination theory is one of the motivational theories most applied today to the analysis of factors related to the adoption of healthy lifestyles Likewise patients who are motivated are more likely to improve healthy habits and obtain greater adherence to exercise performance Therefore we aimed of carrying out an intervention pilot study in ten patients to describe the feasibility of a trimodal prehabilitation program in the hospital environment applying motivational strategies and a mixed-method face-to-face and online
Multimodal prehabilitation includes 1 physical exercise 2 nutritional and 3 psychological support The potential advantages of prehabilitation during neoadjuvant therapy would be 1 the possibility of achieving a better physical condition to face surgery 2 fewer postoperative complications 3 more likely to receive adjuvant treatment after surgery 4 better physical function at the end of treatments To date most studies have focused on lung and prostate cancer with a high prevalence of men in the series
This strategy has previously been explored showing that it is safe and feasible Loughney et al We have not identified any study of trimodal prehabilitation during neoadjuvant treatment and none that has integrated motivational strategies to maintain adherence
Patients during chemotherapy have perceived several adverse effects that could limit adherence to the program In this regard a review on the motivation and exercise in cancer survivors shows that it is necessary to apply theoretical frameworks to understand cognitive and motivational processes and develop educational interventions The self-determination theory is one of the motivational theories most applied today to the analysis of factors related to the adoption of healthy lifestyles Likewise patients who are motivated are more likely to improve healthy habits and obtain greater adherence to exercise performance Therefore we aimed of carrying out an intervention pilot study in ten patients to describe the feasibility of a trimodal prehabilitation program in the hospital environment applying motivational strategies and a mixed-method face-to-face and online
Detailed Description:
outcome measures refer to feasibility of the intervention
Recruitment Attendance to the training sessions Attendance to psychologist and nutritionist sessions
And also to physical condition Cardiorespiratory fitness Muscular strength Body composition Physical activity Quality of life Fatigue score
Recruitment Attendance to the training sessions Attendance to psychologist and nutritionist sessions
And also to physical condition Cardiorespiratory fitness Muscular strength Body composition Physical activity Quality of life Fatigue score
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None