Clinical trial NCT03659123: Prehabilitation & Rehabilitation in Oncogeriatrics: Adaptation to Deconditioning Risk and Accompaniment of Patients' With Cancer
Official title: Prehabilitation & Rehabilitation in Oncogeriatrics: Adaptation to Deconditioning Risk and Accompaniment of Patients' With Cancer, a Multicenter Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Old Injury
Keywords: Elderly
Prehabilitation
Cancer
Surgery
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 148
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Implementation of at least one item of PROADAPT standardized geriatric intervention of the program PROADAPT pilot study
timeFrame: 12 months
measure: Implementation of at least one item of PROADAPT standardized geriatric intervention of the program PROADAPT pilot study
timeFrame: 12 months
measure: Implementation of at least one item of PROADAPT standardized geriatric intervention of the program PROADAPT pilot study
timeFrame: 12 months
measure: Implementation of at least one item of PROADAPT standardized geriatric intervention of the program PROADAPT pilot study
timeFrame: 12 months
measure: Implementation of at least one item of PROADAPT standardized geriatric intervention of the program PROADAPT pilot study
timeFrame: 12 months
measure: Implementation of at least one item of PROADAPT standardized geriatric intervention of the program PROADAPT pilot study
timeFrame: 12 months
measure: Implementation of at least one item of PROADAPT standardized geriatric intervention of the program PROADAPT pilot study
timeFrame: 12 months
Secondary outcomes:
measure: Post operative morbidity
timeFrame: 30 and 90 days
measure: Post-operative morbidity
timeFrame: 90 days
measure: Therapeutic strategy
timeFrame: 12 months
measure: Progression-free Survival
timeFrame: 12 months
measure: Post-treatment complication
timeFrame: 12 months
Other outcomes:
Locations:
city: Chambéry
country: France
facility: Centre Hospitalier de Chambéry
city: Givors
country: France
facility: Centre hospitalier de Givors
city: Lyon
country: France
facility: Centre Hospitalier Edouard Herriot
city: Lyon
country: France
facility: Hôpital Croix Rousse
city: Metz-Tessy
country: France
facility: Centre hospitalier d'Annecy Genevois
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud, Service d'Oncologie Médicale
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud, Service de Gériatrie
city: Saint-Étienne
country: France
facility: Centre hospitalier Universitaire de Saint Etienne
city: Villefranche-sur-Saône
country: France
facility: Hôpital Nord-Ouest
city: Villeurbanne
country: France
facility: Clinique mutualiste Médipole
Study officials:
affiliation: Hospices Civils de Lyon
name: Claire FALANDRY, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.