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

Prehabilitation & Rehabilitation in Oncogeriatrics: Adaptation to Deconditioning Risk and Accompaniment of Patients' With Cancer, a Multicenter Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Old Injury
• Intervention / Treatment: Behavioral: standardized geriatric 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.

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Chambéry, France
    • Centre Hospitalier de Chambéry
  • Givors, France
    • Centre hospitalier de Givors
  • Lyon, France
    • Hopital Croix Rousse
  • Lyon, France
    • Centre Hospitalier Edouard Herriot
  • Metz-Tessy, France
    • Centre Hospitalier d'Annecy Genevois
  • Pierre-Bénite, France
    • Centre Hospitalier Lyon Sud, Service d'Oncologie Médicale
  • Pierre-Bénite, France
    • Centre Hospitalier Lyon Sud, Service de Gériatrie
  • Saint-Étienne, France
    • Centre Hospitalier Universitaire de Saint Etienne
  • Villefranche-sur-Saône, France
    • Hôpital Nord-Ouest
  • Villeurbanne, France
    • Clinique mutualiste Médipole

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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…

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival		12 months
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	90 days
Therapeutic strategy	Treatment plan completion rate: Number of patients for whom the treatment plan was completed.	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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Claire FALANDRY, MD, Hospices Civils de Lyon

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2018
• Primary Completion (Actual): April 27, 2023
• Study Completion (Actual): April 27, 2023

Study Registration Dates

• First Submitted: June 1, 2018
• First Submitted That Met QC Criteria: September 3, 2018
• First Posted (Actual): September 6, 2018

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Elderly; Cancer; Surgery; Prehabilitation
• Other Study ID Numbers: 69HCL16_0701

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No