Trimodal Peri Operative Prehabilitation for Upper Oesogastric and Pancreatic Cancer: A Multicenter, Two-cohort, Open-label, Single-arm POP-UP GERCOR Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 23
- 主要终点
- The rate of eligible patients with successful completion of the 8-week trimodal prehabilitation program
研究概览
简要总结
This is a prospective, multicenter, two-cohort, open-label, single-arm feasibility study of a trimodal (nutritional, psychological, and personalized Adapted Physical Activity (APA)-individualized interventions) 8-week prehabilitation program in patients with localized pancreatic ductal adenocarcinoma (PDAC) or oesogastric cancer (OGC) receiving peri-operative triple chemotherapy and undergoing surgery.
详细描述
The POP-UP study aims to evaluate the feasibility of an 8-week trimodal pre/posthabilitation program (consisting of APA, nutritional assessment, and psychological support) with remote monitoring of the APA sessions and nurse coordination alongside perioperative triplet chemotherapy in patients with localized PDAC (resectable or borderline resectable tumor) or OGC (≥ cT2 or N+).
The prehabilitation program will be conducted during neoadjuvant chemotherapy and the 3-5 weeks prior to surgery for a total of 8 weeks before surgery. There will be a total of three prehabilitation hospital days during the prehabilitation program.
The preoperative prehabilitation will include:
- Once per month, a prehabilitation hospital-day with functional capacities assessment with validated tests made by a physiotherapist or an APA professional (according of center resources/functioning), medical and nurse assessment evaluating performance status, chemotherapy toxicity and tolerance, and nutritional assessment (according to the functioning of each center it will be made by these professionals -with university training on nutrition- or a dietician). A therapeutic training session on the adherence to the prehabilitation program will be done by the nurse (trained in therapeutic education).
- Weekly, an APA professional trainer will follow via using app (Activiti®) the APA home-based program. It will be based on the functional capacities assessment made during the prehabilitation hospital day. The exercise training program will consist of twice per week autonomy sessions, supervised and adapted by the APA professional, and once per week a guided session with the APA professional. The patient will have a total of 3 physical activity sessions per week.
- Once per week, the nurse practitioner (or case manager, according to center functioning) will evaluate the patient via a videoconference to assess the chemotherapy toxicity and tolerance and patient's weight modifications.
The posthabilitation program will start for a total of 8 weeks, one week after surgery discharge. The structure is the same as the prehabilitation program except for the follow of chemotherapy toxicity and tolerance that will be replaced by the follow of the surgical complications/consequences. There will be a total of three posthabilitation days at hospital during the posthabilitation program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated patient informed consent form (ICF) and willingness to comply with all study procedures and availability for the study duration,
- •Histologically or cytologically proven, localized PDAC or OGC,
- •Indication to a neoadjuvant treatment with triplet chemotherapy for ≥ 4 cycles (8 weeks) validated by the multidisciplinary board, Note: Patient treated for PDAC, dose reduction of oxaliplatin or irinotecan is authorized.
- •Age > 18 years; If aged ≥ 75 years: G8 score must be ≥ 14 and if < 14 validation of oncogeriatric specialist,
- •Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1 at the inclusion visit,
- •No prior treatment for PDAC or OGC before starting chemotherapy (FLOT or FOLFIRINOX),
- •At least one measurable or evaluable lesion as assessed by Computerized Tomography scan or Magnetic resonance imaging according to RECIST 1.1 and feasibility of repeated radiological assessments,
- •Adequate hematologic and end-organ function allowing the triple combination chemotherapy protocol,
- •Registration in a national health care system (PUMa - Protection Universelle Maladie included).
排除标准
- •Evidence of metastatic disease at imaging (validated in multidisciplinary team evaluation),
- •Histology of other than adenocarcinoma,
- •Any medical (including cardiovascular, respiratory, psychiatric, musculoskeletal, or neurological) condition contra-indicating exercise practice,
- •Patients with medical contraindication to surgery due to general condition or comorbidities
- •Pregnancy or breast-feeding,
- •Patient under a legal protection regime (guardianship, curatorship, judicial safeguard) or administrative decision or incapable of giving his/her consent,
研究组 & 干预措施
Cohort 1 and Cohort 2
Cohort 1 - Patients with PDAC
Cohort 2 - Patients with OGC
干预措施: Prehabilitation program (Other)
结局指标
主要结局
The rate of eligible patients with successful completion of the 8-week trimodal prehabilitation program
时间窗: 8 weeks
The success of prehabilitation is defined by the achievement of the following three criteria: 1. At least 75% of the (minimum) planned APA sessions, 6 of 8 sessions with an APA professional and 12 of 16 sessions in autonomy with remote APA supervision (note: the total number of APA sessions can be adapted according to the physical activity level of the patient, with a minimum of 8 supervised sessions and 16 autonomy sessions) and 2. Completion of at least 75% of the nutritional evaluations: 6 of 8 planned evaluations and 3. Psychological or psychiatric visit before the surgery in function of practice center /resources if a psychological need is shown by Hospital Anxiety and Depression Scale (HADS).
Rate of patients with successful completion of an 8-week trimodal prehabilitation program
时间窗: 8 weeks
The success of prehabilitation is defined by the achievement of the following three criteria: 1. Completion of at least 75% of the planned APA sessions: 6 of 8 sessions with an APA professional and 12 of 16 sessions in autonomy with remote APA supervision and 2. Completion of at least 75% of the nutritional evaluations: 6 of 8 planned evaluations and 3. Psychological or psychiatric visit before the surgery in function of practice center /resources if a psychological need is shown by Hospital Anxiety and Depression Scale
The feasibility of personalized, 8-week trimodal pre-habilitation program alongside perioperative triplet chemotherapy
时间窗: 8 weeks
The success of pre-habilitation is defined by the achievement of the following three criteria: 1. At least 75% of the (minimum) planned APA sessions, 6 of 8 sessions with an APA professional and 12 of 16 sessions in autonomy with remote APA supervision (note: the total number of APA sessions can be adapted according to the physical activity level of the patient, with a minimum of 8 supervised sessions and 16 autonomy sessions) and 2. Completion of at least 75% of the nutritional evaluations: 6 of 8 planned evaluations and 3. Psychological or psychiatric visit before the surgery in function of practice center /resources if a psychological need is shown by Hospital Anxiety and Depression Scale (HADS).
次要结局
- Disease-free survival (DFS) assessment(up to 12 months after surgery)
- Surgical rate assessment(8 weeks)
- Success rate of APA, nutritional, and psychological interventions(8 weeks)
- Overall survival (OS) assessment(up to 12 months after surgery)
- Health-related quality of life assessment by EORTC QLQ-C30(8 weeks)
- Health-related quality of life assessment by EORTC QLQ-PAN26(8 weeks)
- Health-related quality of life assessment by EORTC QLQ-OG25(8 weeks)
- Postoperative complications assessment(90 days post-surgery)
- Nurse intervention assessment(8 weeks)
- Behavioral changes in physical activity assessment(8 weeks)
- Adherence to APA program assessment(8 weeks)
- Pancreatic function assessment(8 weeks)
- G-CSF use and neutropenia assessment(8 weeks)
- Perioperative chemotherapy rate assessment(8 weeks)
- Chemotherapy dose received(8 weeks)
- Nutritional Status Assessment - Body composition(8 weeks)
- Nutritional Status Assessment - weight and BMI(8 weeks)
- Nutritional Status Assessment - Food intake(8 weeks)
- Nutritional Status Assessment - Serum Albumin evaluation(8 weeks)
- Nutritional Status Assessment - C-Reactive Protein (CRP) evaluation(8 weeks)
- Nutritional Status Assessment - Complete Blood Count (CBC) Parameters evaluation(8 weeks)
- Functional Status Assessment - Physical activity (IPAQ-S)(8 weeks)
- Functional Status Assessment - 6-minute walk test(8 weeks)
- Functional Status Assessment - Handgrip strength(8 weeks)
- Functional Status Assessment - Sit-to-stand test (STS)(8 weeks)
- Functional Status Assessment - Borg scale(8 weeks)
- Functional Status Assessment - Balance(8 weeks)
- Functional Status Assessment - Time Up and Go (≥70 years)(8 weeks)
- Rate of patients who start and complete post-habilitation Adapted Physical Activity (APA) sessions(8 weeks)
- Physical/functional test assessment(8 weeks)
- Nutritional status assessment(8 weeks)
- Number of patients with reduced chemotherapy tolerance(8 weeks)
- Success rate (as defined above) for Adapted Physical Activity (APA), nutritional, and psychological interventions measured separately.(8 weeks)
- Health-related quality of life (HRQoL) assessment(Up to 3 years)
- Rate of patients who complete the strategy(8 weeks)
- Disease-free survival (DFS) assessment(From inclusion up to 12 months after surgery)
- Adherence to Adapted Physical Activity (APA) program assessment(8 weeks)
- Number of patients with chemotherapy dose modification(8 weeks)
- Overall survival (OS) assessment(From inclusion up to 12 months after surgery)
- Number of patients with Granulocyte-colony stimulating factor (G-CSF) prescription and grade ≥ 2 neutropenia(8 weeks)
- Rate of patients with exocrine pancreatic insufficiency and the dose of pancreatic enzyme consumption(8 weeks)
- Physical activity behavior changes assessment(8 weeks)
- Nurse coordination(8 weeks)
- Rate of surgical complications(At 30 days after surgery)
- Chemotherapy tolerance assessment(8 weeks)
- Health-related quality of life assessment by EORTC QLQ-C30(Inclusion, week 4, week 8, week +1, week +5, Week +9, follow-up (up to 17 months))
- Health-related quality of life assessment by EORTC QLQ-PAN26(Inclusion, week 4, week 8, week +1, week +5, Week +9, follow-up (up to 17 months))
- Health-related quality of life assessment by EORTC QLQ-OG25(Inclusion, week 4, week 8, week +1, week +5, Week +9, follow-up (up to 17 months))
- Postoperative complications assessment(Surgery and postoperative period (up to 90 days post-surgery))
- Adherence to APA program assessment(Inclusion, week 4, week 8, week +1, week +5, week +9)
- Pancreatic function assessment(week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years))
- Surgical rate assessment(Surgery and postoperative period)
- Nutritional Status Assessment - Body composition(Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years))
- Nutritional Status Assessment - weight and BMI(Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years))
- Nutritional Status Assessment - Food intake(Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years))
- Nutritional Status Assessment - Serum Albumin evaluation(Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years))
- Nutritional Status Assessment - C-Reactive Protein (CRP) evaluation(Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years))
- Nutritional Status Assessment - Complete Blood Count (CBC) Parameters evaluation(Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months), end of study (at 4 years))
- Functional Status Assessment - Behavioral changes in physical activity (International Physical Activity Questionnaire [IPAQ-S])(Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months))
- Functional Status Assessment - 6-minute walk test(Inclusion, week 4, week 8, week +1, week +5, week +9)
- Functional Status Assessment - Handgrip strength(Inclusion, week 4, week 8, week +1, week +5, week +9)
- Functional Status Assessment - Sit-to-stand test (STS)(Inclusion, week 4, week 8, week +1, week +5, week +9)
- Functional Status Assessment - Borg scale(Inclusion, week 4, week 8, week +1, week +5, week +9)
- Functional Status Assessment - Balance(Inclusion, week 4, week 8, week +1, week +5, week +9)
- Functional Status Assessment - Time Up and Go (≥70 years)(Inclusion, week 4, week 8, week +1, week +5, week +9)
- Hospital Anxiety and Depression Scale (HADS) assessment(Inclusion, week 4, week 8, week +1, week +5, week +9, follow-up visits (up to 17 months))