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

Old Injury Clinical Trial

— PROADAPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03659123
• Other study ID #: 69HCL16_0701
• Status: Completed
• Phase: N/A
• Start date: July 3, 2018
• Est. completion date: April 27, 2023

Study information

• Verified date: August 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: April 27, 2023
• Est. primary completion date: April 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Old Injury

Intervention

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.

Locations

Country	Name	City	State
France	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	Centre hospitalier Universitaire de Saint Etienne	Saint-Étienne
France	Hôpital Nord-Ouest	Villefranche-sur-Saône
France	Clinique mutualiste Médipole	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Post operative morbidity	Post operative morbidity according Clavien-Dindo classification	30 and 90 days
Secondary	Post-operative morbidity	Post-operative morbidity according to NCI CTC v4.4	90 days
Secondary	Therapeutic strategy	Treatment plan completion rate: Number of patients for whom the treatment plan was completed.	12 months
Secondary	Progression-free Survival		12 months
Secondary	Post-treatment complication	Post-treatment complication grade=3 according the National Cancer Institute Common Toxicity Criteria version 4 (NCI-CTC-v4)	12 months