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).
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
14
Pancreatic cancer patients (not stage 4) will undergo trimodal prehabilitation: nutrition, psychological, and exercise support.
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
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
Time frame: 1 year
Changes in (estimated) cardiorespiratory fitness
Mile-time test
Time frame: 3-6 months (from 1st treatment to surgery)
Changes in muscle strength
Handgrip by dynamometry
Time frame: 3-6 months (from 1st treatment to surgery)
Changes in body mass index
BMI (Body Mass Index kg/sm)
Time frame: 3-6 months (from 1st treatment to surgery)
Changes in body composition
waist, hip, calf circumferences
Time frame: 3-6 months (from 1st treatment to surgery)
Changes in levels of physical activity at week
Accelerometry
Time frame: 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.
Time frame: 3-6 months (from before1st treatment to surgery)
Describe changes in fatigue levels
PERFORM (Multidimensional scale 12-60. The higher the less fatigue)
Time frame: 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
Time frame: 3-6 months (from 1st treatment to surgery)
Describe post-surgical complications
Surgical wound and pancreatic fistula
Time frame: three months
Nutritional status
body mass index
Time frame: 3-6 months (from 1st treatment to surgery)
Percentage of pathological complete responses
Percentage of patients with no viable cells in the surgical specimen
Time frame: 4-6 weeks after surgery
Percentage of patients receiving adjuvant therapy
Patients that received at least two cycles after surgery
Time frame: Three months after surgery
Hindrances and facilitators of patients
Qualitative methods. semi-structured interviews and observation
Time frame: During the prehabilitation program (3-6 months for each patient)
Anxiety and depression
Hospital Anxiety and Depression Scale questionnaire. Values 8-21. The higher the worse
Time frame: 3-6 months (from 1st treatment to surgery)
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