Prehabilitation & Rehabilitation in Oncogeriatrics: Adaptation to Deconditioning Risk and Accompaniment of Patients' With Cancer

NCT ID: NCT03659123

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-03

Study Completion Date

2023-04-27

Brief Summary

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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 - that associate chemotherapy and/or radiotherapy and surgery, 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 events 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 beneficial. However, the actual level of evidence depends on the interventions: high for pre-operative nutrition, but low for physical exercise, due to heterogeneous programs with often bad adherence. In addition, geriatric validated interventions, in order to prevent iatrogenic event, may be added in a multi-interventional model of intervention.

Detailed Description

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PROADAPT pilot study is a standardized geriatric intervention constructed on a multi-professional and multi-disciplinary basis after a systematic analysis of published data.

This intervention was designed to be implemented pragmatically in the centers according local habits in several distinct hospital contexts in different tumor contexts.

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.

Conditions

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Old Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention

The intervention is designed to be implemented at different times of patients' care

During the prehabilitation time:

* Nutritional care
* Total-body rehabilitation
* Pharmaceutical conciliation During peri-operative time
* Management of enhances rehabilitation of the elderly. During rehabilitation time
* Nutritional, medication conciliation and functional follow-up During hospital-home transition time
* Nutritional and functional follow-up
* Optimisation of symptoms management: abdominal pain, nausea, vomiting…

Group Type EXPERIMENTAL

standardized geriatric intervention

Intervention Type BEHAVIORAL

Nutritional care is based on:

* A personalized evaluation of nutritional balance and nutritional needs of the patient
* A weekly follow-up of weight and nutritional intake

Total-body rehabilitation is based on:

* 2 to 3 times a week: strength exercise
* 2 to 3 times a week: endurance exercise, 20 to 45 min each sequence
* 2 times a week: respiratory physiotherapy Pharmaceutical conciliation and optimization according STOPP/START criteria During peri-operative time, the nurse contacts the surgical team for transmission of patient's personal data, physical medication conciliation results During rehabilitation time and hospital-home transition time, the nurse contacts the rehabilitation team for transmission of patient's personal data and care course, physical (nutritional, functional and/or comorbidities), medication conciliation results.

Interventions

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standardized geriatric intervention

Nutritional care is based on:

* A personalized evaluation of nutritional balance and nutritional needs of the patient
* A weekly follow-up of weight and nutritional intake

Total-body rehabilitation is based on:

* 2 to 3 times a week: strength exercise
* 2 to 3 times a week: endurance exercise, 20 to 45 min each sequence
* 2 times a week: respiratory physiotherapy Pharmaceutical conciliation and optimization according STOPP/START criteria During peri-operative time, the nurse contacts the surgical team for transmission of patient's personal data, physical medication conciliation results During rehabilitation time and hospital-home transition time, the nurse contacts the rehabilitation team for transmission of patient's personal data and care course, physical (nutritional, functional and/or comorbidities), medication conciliation results.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patient ≥70 year old OR patient ≥60 years with significant comorbid condition (modified Charlson index≥3) or disability (ADL score\<6/6);
* Histologically or cytologically proven cancer.
* Life expectancy \> 3 months.
* Written informed consent obtained
* Covered by a Health System where applicable.

Exclusion Criteria

* Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
* Patient unable to be regularly followed for any reason (geographic, familial, social, psychologic).
* Any mental or physical handicap at risk of interfering with the appropriate treatment.
* Any administrative or legal supervision where applicable
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claire FALANDRY, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Centre Hospitalier de Chambéry

Chambéry, , France

Site Status

Centre hospitalier de Givors

Givors, , France

Site Status

Centre Hospitalier Edouard Herriot

Lyon, , France

Site Status

Hôpital Croix Rousse

Lyon, , France

Site Status

Centre hospitalier d'Annecy Genevois

Metz-Tessy, , France

Site Status

Centre Hospitalier Lyon Sud, Service d'Oncologie Médicale

Pierre-Bénite, , France

Site Status

Centre Hospitalier Lyon Sud, Service de Gériatrie

Pierre-Bénite, , France

Site Status

Centre hospitalier Universitaire de Saint Etienne

Saint-Etienne, , France

Site Status

Hôpital Nord-Ouest

Villefranche-sur-Saône, , France

Site Status

Clinique mutualiste Médipole

Villeurbanne, , France

Site Status

Countries

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France

References

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Roche M, Ravot C, Malapert A, Paget-Bailly S, Garandeau C, Pitiot V, Tomatis M, Riche B, Galamand B, Granger M, Barbavara C, Bourgeois C, Genest E, Stefani L, Haine M, Castel-Kremer E, Morel-Soldner I, Collange V, Le Saux O, Dayde D, Falandry C; PROADAPT working group. Feasibility of a prehabilitation programme dedicated to older patients with cancer before complex medical-surgical procedures: the PROADAPT pilot study protocol. BMJ Open. 2021 Apr 2;11(4):e042960. doi: 10.1136/bmjopen-2020-042960.

Reference Type RESULT
PMID: 33811052 (View on PubMed)

Other Identifiers

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69HCL16_0701

Identifier Type: -

Identifier Source: org_study_id

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