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

Not Applicable
Completed
Conditions
Old Injury
Interventions
Behavioral: standardized geriatric intervention
Registration Number
NCT03659123
Lead Sponsor
Hospices Civils de Lyon
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
148
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.
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Interventionstandardized geriatric interventionThe 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...
Primary Outcome Measures
NameTimeMethod
Implementation of at least one item of PROADAPT standardized geriatric intervention of the program PROADAPT pilot study12 months

Bridging interventions for hospital-to-home transition. Number of patients with at least 1 intervention achieved in the domain

Secondary Outcome Measures
NameTimeMethod
Progression-free Survival12 months
Therapeutic strategy12 months

Treatment plan completion rate: Number of patients for whom the treatment plan was completed.

Post-treatment complication12 months

Post-treatment complication grade≥3 according the National Cancer Institute Common Toxicity Criteria version 4 (NCI-CTC-v4)

Post operative morbidity30 and 90 days

Post operative morbidity according Clavien-Dindo classification

Post-operative morbidity90 days

Post-operative morbidity according to NCI CTC v4.4

Trial Locations

Locations (10)

Centre Hospitalier de Chambéry

🇫🇷

Chambéry, France

Centre hospitalier de Givors

🇫🇷

Givors, France

Centre Hospitalier Edouard Herriot

🇫🇷

Lyon, France

Hôpital Croix Rousse

🇫🇷

Lyon, France

Centre hospitalier d'Annecy Genevois

🇫🇷

Metz-Tessy, France

Centre Hospitalier Lyon Sud, Service d'Oncologie Médicale

🇫🇷

Pierre-Bénite, France

Centre Hospitalier Lyon Sud, Service de Gériatrie

🇫🇷

Pierre-Bénite, France

Hôpital Nord-Ouest

🇫🇷

Villefranche-sur-Saône, France

Clinique mutualiste Médipole

🇫🇷

Villeurbanne, France

Centre hospitalier Universitaire de Saint Etienne

🇫🇷

Saint-Étienne, France

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