PROADAPT-ovary/EWOC-2

NCT04284969 | Recruiting

• 1 other identifier: 69HCL18_0359
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 11

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).

Conditions

Ovarian Cancer; Surgery

Keywords

Cytoreductive surgery; Older; Senior adult; Prehabilitation

Outcome Measures

Primary Outcomes (2)

• 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

  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

  At 3 months

Secondary Outcomes (4)

• Post-operative morbidity according Clavien-Dindo classification at 30 and 90 days

  At 30 and 90 days

• Therapeutic strategy (treatment plan completion rate)

  2 years

• Progression free survival

  2 years

• Overall survival

  2 years

Study Arms (2)

Control arm

NO INTERVENTION

Patients treated according current practice of the inclusion center. If interventions are implemented locally (geriatric assessment, nutrition, physical activity) they may be proposed to the patient.

Intervention arm : PROADAPT program

EXPERIMENTAL

Patients benefiting from the PROADAPT (interventional arm) program.

Behavioral: PROADAPT program

Interventions

PROADAPT program BEHAVIORAL

* 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.

Intervention arm : PROADAPT program

Eligibility Criteria

• Age: 70 Years+
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (11)

Chu Bordeaux Pellegrin

Bordeaux, 33000, France

COMPLETED

CH Métropole Savoie

Chambéry, 73000, France

RECRUITING

Centre Georges François Leclerc

Dijon, 21079, France

RECRUITING

Hôpital Croix Rousse

Lyon, 69004, France

RECRUITING

Service de Gériatrie, Centre Hospitalier Lyon Sud, 165 chemin du Grand Revoyet

Pierre-Bénite, 69495, France

RECRUITING

Centre hospitalier Annecy Genevois

Pringy, 74374, France

RECRUITING

CHU de St Etienne - Service gynécologie

Saint-Priest-en-Jarez, 42270, France

RECRUITING

CHU Nord Saint Etienne - Service oncologie médicale

Saint-Priest-en-Jarez, 42270, France

RECRUITING

Institut Gustave Roussy

Villejuif, 94805, France

RECRUITING

Médipôle Hôpital Mutualiste

Villeurbanne, 69616, France

RECRUITING

Villeurbanne Médipole MHP

Villeurbanne, 69616, France

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Claire FALANDRY, PR

CONTACT

4.78.86.32.87; claire.falandry@chu-lyon.fr

Noual BAKRIN, MD

CONTACT

naoual.bakrin@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: February 26, 2020
• Study Start: June 3, 2021
• Primary Completion (Estimated): June 3, 2027
• Study Completion (Estimated): March 3, 2029
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

FR (11)