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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The intervention is designed to be implemented at different times of patients' care During the prehabilitation time:
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standardized geriatric intervention | Behavioral | Nutritional care is based on:
Total-body rehabilitation is based on:
|
| Measure | Description | Time Frame |
|---|---|---|
| Implementation of at least one item of PROADAPT standardized geriatric intervention of the program PROADAPT pilot study | Preoperative physical activity including strength and endurance exercise assessed by physical exercises accomplished under the supervision of a physiotherapist. Number of patients with at least 1 intervention achieved in the domain. | 12 months |
| Implementation of at least one item of PROADAPT standardized geriatric intervention of the program PROADAPT pilot study | Nutrition guidelines before and after physical activity assessed by questionnaires. Number of patients with at least 1 intervention achieved in the domain. | 12 months |
| Implementation of at least one item of PROADAPT standardized geriatric intervention of the program PROADAPT pilot study | Patient education and coaching assessed by questionnaires and visits. Number of patients with at least 1 intervention achieved in the domain | 12 months |
| Implementation of at least one item of PROADAPT standardized geriatric intervention of the program PROADAPT pilot study | Achievement of standardized intervention procedures, according to the checklist established in consensus with surgeons. Number of patients with at least 1 intervention achieved in the domain | 12 months |
| Implementation of at least one item of PROADAPT standardized geriatric intervention of the program PROADAPT pilot study | Rehabilitation assessed by questionnaires. Number of patients with at least 1 intervention achieved in the domain | 12 months |
| Implementation of at least one item of PROADAPT standardized geriatric intervention of the program PROADAPT pilot study |
| Measure | Description | Time Frame |
|---|---|---|
| Post operative morbidity | Post operative morbidity according Clavien-Dindo classification | 30 and 90 days |
| Post-operative morbidity | Post-operative morbidity according to NCI CTC v4.4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claire FALANDRY, MD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de Chambéry | Chambéry | France | ||||
| Centre hospitalier de Givors |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33811052 | Result | 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. |
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|
Accomplishment of pharmaceutical medication conciliation and treatment optimization. Number of patients with at least 1 intervention achieved in the domain |
| 12 months |
| Implementation of at least one item of PROADAPT standardized geriatric intervention of the program PROADAPT pilot study | Bridging interventions for hospital-to-home transition. Number of patients with at least 1 intervention achieved in the domain | 12 months |
| 90 days |
| Therapeutic strategy | Treatment plan completion rate: Number of patients for whom the treatment plan was completed. | 12 months |
| Progression-free Survival | 12 months |
| Post-treatment complication | Post-treatment complication grade≥3 according the National Cancer Institute Common Toxicity Criteria version 4 (NCI-CTC-v4) | 12 months |
| 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 |
| Centre hospitalier Universitaire de Saint Etienne | Saint-Etienne | France |
| Hôpital Nord-Ouest | Villefranche-sur-Saône | France |
| Clinique mutualiste Médipole | Villeurbanne | France |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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