Trimodal Prehabilitation in Pancreatic Cancer Patients Urdergoing Neoadjuvant Treatment

Study Overview
=================
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 (SDT, Deci and Ryan) 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

Official Title
-----------------
Trimodal Prehabilitation in Pancreatic Cancer Patients Candidate to Neoadjuvant Treatment: A Pilot Study

Conditions
-----------------
Pancreatic Neoplasms

Intervention / Treatment
-----------------
* Combination Product: Trimodal prehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: More than 18 years old ECOG 0-2 Being able to complete the mile-time test Stages I-III Being able to understand the informed consent Pancreatic cancer diagnosed Exclusion Criteria: Metastasic cancer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: All the participants will receive trimodal prehabilitation. Only one arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training group<br>Pancreatic patients will participate in the trimodal prehabilitation: nutrition, psychological and exercise support. | Combination Product: Trimodal prehabilitation<br>* Pancreatic cancer patients (not stage 4) will undergo trimodal prehabilitation: nutrition, psychological, and exercise support.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To explore the feasibility of a trimodal prehabilitation program in the hospital setting | Adherence to 70% of supervised physical exercise sessions and to nutrition and psychologist sessions | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in (estimated) cardiorespiratory fitness | Mile-time test | 3-6 months (from 1st treatment to surgery) | 
| Changes in muscle strength | Handgrip by dynamometry | 3-6 months (from 1st treatment to surgery) | 
| Changes in body mass index | BMI (Body Mass Index kg/sm) | 3-6 months (from 1st treatment to surgery) | 
| Changes in body composition | waist, hip, calf circumferences | 3-6 months (from 1st treatment to surgery) | 
| Changes in levels of physical activity at week | Accelerometry | 3-6 months (from 1st treatment to surgery) | 
| Changes in quality of life | EORTC-QLQ-C30 (European Organization for Research and Treatment of Cancer. Quality of Life questionnaire. C30. all scores of the QLQ-C30 were transformed linearly so that all scales ranged from 0 to 100. In the function scales higher scores represent a better level of functioning while in the case of symptom scales/items higher scores mark a higher level of symptomatology or problems. | 3-6 months (from before1st treatment to surgery) | 
| Describe changes in fatigue levels | PERFORM (Multidimensional scale 12-60. The higher the less fatigue) | 3-6 months (from before 1st treatment to surgery) | 
| Dose intensity in neoadjuvant treatment | percentage of intended doses that are administered in the due time | 3-6 months (from 1st treatment to surgery) | 
| Describe post-surgical complications | Surgical wound and pancreatic fistula | three months | 
| Nutritional status | body mass index | 3-6 months (from 1st treatment to surgery) | 
| Percentage of pathological complete responses | Percentage of patients with no viable cells in the surgical specimen | 4-6 weeks after surgery | 
| Percentage of patients receiving adjuvant therapy | Patients that received at least two cycles after surgery | Three months after surgery | 
| Hindrances and facilitators of patients | Qualitative methods. semi-structured interviews and observation | During the prehabilitation program (3-6 months for each patient) | 
| Anxiety and depression | HADS questionnaire. Values 8-21. The higher the worse | 3-6 months (from 1st treatment to surgery) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise, pancreatic, cancer, trimodal