PROADAPT-ovary/EWOC-2

Official title

Prehabilitation & Rehabilitation in Oncogeriatrics: Adaptation to Deconditioning Risk and Accompaniment of Patients' Trajectories-ovary/Elderly Women With Ovarian Cancer-2, a GINECO Multicenter Randomized Study (PROADAPT-ovary/EWOC-2)

Overview

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).

Detailed description

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.

Interventions

• Behavioral PROADAPT program
  * 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 p

Primary outcome measures

• Superiority for post-treatment complication grade≥3 [Time frame: At 30 days post-treatment]
• Superiority of HRQOL on the dimensions [Time frame: At 3 months]

Secondary outcome measures (4)

• Post-operative morbidity according Clavien-Dindo classification at 30 and 90 days [Time frame: At 30 and 90 days]
• Therapeutic strategy (treatment plan completion rate) [Time frame: 2 years]
• Progression free survival [Time frame: 2 years]
• Overall survival [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

• Woman ≥70 year old OR Woman ≥60 years with significant comorbid condition (modified Charlson index≥3) or disability (ADL score<6/6);
• Histologically or cytologically proven FIGO (International Federation of Gynecology and Obstetrics) stage III to IV epithelial ovarian cancer or peritoneal primary or fallopian tube. A cytological proof is accepted if associated with a ratio of CA125/CEA >25 and a radiological pelvic mass.
• Patient oriented towards a complex medical procedure defined by pelvic surgery preceded or not by antineoplastic treatment (neoadjuvant chemotherapy).
• Therapeutic decision validated in a multidisciplinary consultation meeting
• Life expectancy > 3 months.
• Written informed consent obtained.
• Covered by a Health System where applicable.

Exclusion criteria

• Any other progressive malignant tumor interfering with the patient's prognosis.
• Patient whose validated therapeutic management does not include cytoreductive surgery.
• Patient unable to be regularly followed up for any reason (geographic, family, social, psychological).
• Patient unable to understand the questionnaires.
• Patient unable to follow and adhere to test procedures for geographic, social or psychological reasons.
• Patient placed under guardianship or curatorship.
• Patient deprived of liberty.
• Concurrent participation in another interventional drug trial.
• Patient already included in this study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 11 centers

• Chu Bordeaux Pellegrin — Bordeaux
• CH Métropole Savoie — Chambéry
• Centre Georges François Leclerc — Dijon
• Hôpital Croix Rousse — Lyon
• Service de Gériatrie, Centre Hospitalier Lyon Sud, 165 chemin du Grand Revoyet — Pierre-Bénite
• Centre hospitalier Annecy Genevois — Pringy
• CHU de St Etienne - Service gynécologie — Saint-Priest-en-Jarez
• CHU Nord Saint Etienne - Service oncologie médicale — Saint-Priest-en-Jarez
• … and 3 more centers

Identifiers

NCT: NCT04284969 · 69HCL18_0359

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗