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NCT Number: NCT04284969

PROADAPT-ovary/EWOC-2

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).

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Key information

Age range

70 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chu Bordeaux Pellegrin, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Superiority for post-treatment complication grade≥3

    Time frame: At 30 days post-treatment

    • Superiority for post-treatment complication grade≥3 according the NCI-CTC-v4 (Common Terminology Criteria : CTC) at 30 days
  2. Superiority of HRQOL on the dimensions

    Time frame: At 3 months

    Superiority of HRQOL on the dimensions: Mobility, burden of illness, emotional and physical functioning, fatigue, at 3 months

Secondary outcomes

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

    Time frame: 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.

  2. Therapeutic strategy (treatment plan completion rate)

    Time frame: 2 years

    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.

  3. Progression free survival

    Time frame: 2 years

    Progression-free survival (PFS) is defined as the time from random assignment to disease progression or death from any cause.

  4. Overall survival

    Time frame: 2 years

    Overall survival is defined as the time from randomization to death from any cause

Study contacts

Contact information is provided by the study sponsor or research team.

Claire FALANDRY, PR

CONTACT

[email protected]

4.78.86.32.87 ext. +33

Noual BAKRIN, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2027
Study completion
2029
First posted
Feb 26, 2020
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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