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

Civil Hospices of Lyon

Status: Completed

Conditions: Old Injury

Treatments: Behavioral: standardized geriatric intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03659123

69HCL16_0701

Details and patient eligibility

About

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.

Full 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.

Enrollment: 148 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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148 participants in 1 patient group

Intervention

Experimental group

Description:

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…

Treatment:

Behavioral: standardized geriatric intervention