PROADAPT-ovary/EWOC-2

Condition(s) studied

Investigational drug(s) / intervention(s)

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 pharmaceutical expertise. * A transition activity from the hospital to the home, and a telephone follow-up up to 12 weeks after the surgery.

Study summary

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).

Eligibility

Primary outcome measure(s)

• Superiority for post-treatment complication grade≥3 — At 30 days post-treatment
  • Superiority for post-treatment complication grade≥3 according the NCI-CTC-v4 (Common Terminology Criteria : CTC) at 30 days
• Superiority of HRQOL on the dimensions — At 3 months
  Superiority of HRQOL on the dimensions: Mobility, burden of illness, emotional and physical functioning, fatigue, at 3 months

Trial sites (11)

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