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Old InjuryPROADAPTNCT03659123

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

A study testing standardized geriatric intervention in people with Old Injury, run by Hospices Civils de Lyon at 10 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Old Injury
What is being tested?
standardized geriatric intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
148 participants
Where
10 sitesFrance
Study dates
3 Jul 2018to 27 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

10 sites in 1 country.

10 sites in 1 country

France10 sites

  • Centre Hospitalier de Chambéry

    Chambéry

  • Centre hospitalier de Givors

    Givors

  • Centre Hospitalier Edouard Herriot

    Lyon

  • Hôpital Croix Rousse

    Lyon

  • Centre hospitalier d'Annecy Genevois

    Metz-Tessy

  • Centre Hospitalier Lyon Sud, Service d'Oncologie Médicale

    Pierre-Bénite

  • Centre Hospitalier Lyon Sud, Service de Gériatrie

    Pierre-Bénite

  • Centre hospitalier Universitaire de Saint Etienne

    Saint-Etienne

  • Hôpital Nord-Ouest

    Villefranche-sur-Saône

  • Clinique mutualiste Médipole

    Villeurbanne

Other trials in France

About this study

Official title: 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.

Read the 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.
Conditions
Old Injury
Being tested
standardized geriatric intervention
Keywords
Elderly, Prehabilitation, Cancer, Surgery
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • standardized geriatric interventionBehavioural

    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.
Study groups in NCT03659123
Study groupRoleWhat they receive
InterventionExperimentalThe 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…
Receives: Behavioral: standardized geriatric intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

  2. 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.

    Measured: 12 months

  3. 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

    Measured: 12 months

  4. 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

    Measured: 12 months

  5. 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

    Measured: 12 months

  6. 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

    Measured: 12 months

  7. 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

    Measured: 12 months

Secondary outcomes (5)

  1. Post operative morbidity

    Post operative morbidity according Clavien-Dindo classification

    Measured: 30 and 90 days

  2. Post-operative morbidity

    Post-operative morbidity according to NCI CTC v4.4

    Measured: 90 days

  3. Therapeutic strategy

    Treatment plan completion rate: Number of patients for whom the treatment plan was completed.

    Measured: 12 months

  4. Progression-free Survival

    Measured: 12 months

  5. Post-treatment complication

    Post-treatment complication grade≥3 according the National Cancer Institute Common Toxicity Criteria version 4 (NCI-CTC-v4)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2018
  2. Study start3 Jul 2018
  3. Primary completion27 Apr 2023
  4. Study completion27 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
148 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03659123
Sponsor's protocol ID
69HCL16_0701
Acronym
PROADAPT
Status last verified
Nov 2025
First submitted
1 Jun 2018
Last updated
3 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 33811052

Questions about this trial

What is this clinical trial studying?

A study testing standardized geriatric intervention in people with Old Injury, run by Hospices Civils de Lyon at 10 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implementation of at least one item of PROADAPT standardized geriatric intervention of the program PROADAPT pilot study (time frame: 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03659123, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.

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