PROADAPT is a standardized geriatric intervention that is currently being co-constructed during an exploratory phase on a multi-professional and multi-disciplinary basis after a systematic analysis of published data (Figure). It consists in: 1) before surgery: a prehabilitation of the patients including a nutritional, physical and educational preparation; 2) during the hospitalization for surgery: an optimisation of their treatments through a pharmaceutical conciliation, educational interventions, standardization of surgical procedures and enhanced rehabilitation after surgery; 3) bridging and post-discharge interventions for hospital-to-home transition. This intervention is based on a logic change model, constructed with literature data and validated by an expert group through a DELPHI method : the rehabilitation model. This intervention was designed to be implemented pragmatically in the centers according local habits and is currently being evaluated in several distinct hospital contexts under the name of "PROADAPT pilot study" in different tumor contexts thanks to a grant from the Regional Health Agency of Rhône-Alpes Auvergne region. PROADAPT intervention is planned to be evaluated in 4 tumor models inducing complex medico-surgical procedures considered at high risk of geriatric deconditioning. They have the same primary objectives in order to be evaluated into a meta-analysis. Results will be used to test the validity of the rehabilitation model. Therefore, it is a study reaching the goal of the population health intervention research. The purpose of the PROADAPT-ovary/EWOC-2 study is to evaluate the impact of PROADAPT on patient's post-surgical outcomes in patients ≥ 70 years old with an advanced ovarian cancer (AOC).
With the conjunction of increased life expectancy and the increasing incidence of cancer with aging, older patient represent an increasing proportion of cancer patients. Increasing age is also associated with increased risk of co-morbidities as well as a decline of functional reserve of multiple organ systems, eventually leading in the context of the disease-and/or the treatment-related stress to functional deconditioning or organ failure. Surgery or complex medico-surgical procedures can be considered as one proof-of principle of such risks, since major cancer surgery the older population is at higher risk of morbi-mortality and unplanned hospitalization for geriatric events1. In order to reduce complications after surgery, prehabilitation has often been considered, and 71% of the surgeons would accept a 4 weeks delay before surgery to improve patients' outcomes if shown to be beneficial2. However, the actual level of evidence depends on the interventions: high for pre-operative nutrition3, but low for physical exercise, due to heterogeneous programs with often bad adherence4. In addition, geriatric validated interventions, in order to prevent iatrogenic event, may be added in a multi-interventional model of intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
292
* A pre-intervention activity by telephone follow-ups every week for 12 weeks and then every month. * Pre-operative physical training including strength, endurance and breathing exercises. * A nutrition activity. * An activity to educate patients (on nutrition, exercise). * The implementation of standardised intervention procedures, established in agreement with the surgeons' representatives. * A pharmaceutical drug conciliation activity: optimization of the patient's different treatments with pharmaceutical expertise. * A transition activity from the hospital to the home, and a telephone follow-up up to 12 weeks after the surgery.
Chu Bordeaux Pellegrin
Bordeaux, France
COMPLETEDCH Métropole Savoie
Chambéry, France
RECRUITINGCentre Georges François Leclerc
Dijon, France
RECRUITINGHôpital Croix Rousse
Lyon, France
RECRUITINGService de Gériatrie, Centre Hospitalier Lyon Sud, 165 chemin du Grand Revoyet
Pierre-Bénite, France
RECRUITINGCentre hospitalier Annecy Genevois
Pringy, France
RECRUITINGCHU de St Etienne - Service gynécologie
Saint-Priest-en-Jarez, France
RECRUITINGCHU Nord Saint Etienne - Service oncologie médicale
Saint-Priest-en-Jarez, France
RECRUITINGInstitut Gustave Roussy
Villejuif, France
RECRUITINGMédipôle Hôpital Mutualiste
Villeurbanne, France
RECRUITING...and 1 more locations
Superiority for post-treatment complication grade≥3
• Superiority for post-treatment complication grade≥3 according the NCI-CTC-v4 (Common Terminology Criteria : CTC) at 30 days
Time frame: At 30 days post-treatment
Superiority of HRQOL on the dimensions
Superiority of HRQOL on the dimensions: Mobility, burden of illness, emotional and physical functioning, fatigue, at 3 months
Time frame: At 3 months
Post-operative morbidity according Clavien-Dindo classification at 30 and 90 days
Clavien Dindo classification consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study. Complications that have the potential for long-lasting disability after patient's discharge (e.g.: paralysis of a voice cord after thyroid surgery) are highlighted in the present classification by a suffix ("d" for disability). This suffix indicates that a follow-up is required to comprehensively evaluate the outcome and related long-term quality of life.
Time frame: At 30 and 90 days
Therapeutic strategy (treatment plan completion rate)
A complete therapeutic strategy consists of a complete cytoreductive surgery (CC0) 6 courses of chemotherapy at least in total, either in neo-adjuvant or in adjuvant setting, with at least 2 courses after surgery.
Time frame: 2 years
Progression free survival
Progression-free survival (PFS) is defined as the time from random assignment to disease progression or death from any cause.
Time frame: 2 years
Overall survival
Overall survival is defined as the time from randomization to death from any cause
Time frame: 2 years
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