Clinical trial NCT04284969: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Surgery
Keywords: Cytoreductive surgery
Older
Senior adult
Prehabilitation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 292
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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).

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.

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

Primary outcomes:
measure: Superiority for post-treatment complication grade≥3
timeFrame: At 30 days post-treatment
measure: Superiority of HRQOL on the dimensions
timeFrame: At 3 months
Secondary outcomes:
measure: Post-operative morbidity according Clavien-Dindo classification at 30 and 90 days
timeFrame: At 30 and 90 days
measure: Therapeutic strategy (treatment plan completion rate)
timeFrame: 2 years
measure: Progression free survival
timeFrame: 2 years
measure: Overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Chu Bordeaux Pellegrin
city: Chambery
country: France
facility: CH Métropole Savoie
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Lyon
country: France
facility: Hôpital Croix Rousse
city: Pierre-Bénite
country: France
facility: Service de Gériatrie, Centre Hospitalier Lyon Sud, 165 chemin du Grand Revoyet
city: Pringy
country: France
facility: Centre hospitalier Annecy Genevois
city: Saint-Priest-en-Jarez
country: France
facility: CHU de St Etienne - Service gynécologie
city: Saint-Priest-en-Jarez
country: France
facility: CHU Nord Saint Etienne - Service oncologie médicale
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Villeurbanne
country: France
facility: Médipôle Hôpital Mutualiste
city: Villeurbanne
country: France
facility: Villeurbanne Médipole MHP
Study officials:
References: