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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03659123
Recruitment Status : Unknown
Verified February 2021 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : September 6, 2018
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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.


Condition or disease Intervention/treatment Phase
Old Injury Behavioral: standardized geriatric intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Prehabilitation & Rehabilitation in Oncogeriatrics: Adaptation to Deconditioning Risk and Accompaniment of Patients' With Cancer, a Multicenter Pilot Study
Actual Study Start Date : July 3, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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.




Primary Outcome Measures :
  1. Implementation of at least one item of PROADAPT standardized geriatric intervention of the program PROADAPT pilot study [ Time Frame: 12 months ]
    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.

  2. Implementation of at least one item of PROADAPT standardized geriatric intervention of the program PROADAPT pilot study [ Time Frame: 12 months ]
    Nutrition guidelines before and after physical activity assessed by questionnaires. Number of patients with at least 1 intervention achieved in the domain.

  3. Implementation of at least one item of PROADAPT standardized geriatric intervention of the program PROADAPT pilot study [ Time Frame: 12 months ]
    Patient education and coaching assessed by questionnaires and visits. Number of patients with at least 1 intervention achieved in the domain

  4. Implementation of at least one item of PROADAPT standardized geriatric intervention of the program PROADAPT pilot study [ Time Frame: 12 months ]
    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

  5. Implementation of at least one item of PROADAPT standardized geriatric intervention of the program PROADAPT pilot study [ Time Frame: 12 months ]
    Rehabilitation assessed by questionnaires. Number of patients with at least 1 intervention achieved in the domain

  6. Implementation of at least one item of PROADAPT standardized geriatric intervention of the program PROADAPT pilot study [ Time Frame: 12 months ]
    Accomplishment of pharmaceutical medication conciliation and treatment optimization. Number of patients with at least 1 intervention achieved in the domain

  7. Implementation of at least one item of PROADAPT standardized geriatric intervention of the program PROADAPT pilot study [ Time Frame: 12 months ]
    Bridging interventions for hospital-to-home transition. Number of patients with at least 1 intervention achieved in the domain


Secondary Outcome Measures :
  1. Post operative morbidity [ Time Frame: 30 and 90 days ]
    Post operative morbidity according Clavien-Dindo classification

  2. Post-operative morbidity [ Time Frame: 90 days ]
    Post-operative morbidity according to NCI CTC v4.4

  3. Therapeutic strategy [ Time Frame: 12 months ]
    Treatment plan completion rate: Number of patients for whom the treatment plan was completed.

  4. Progression-free Survival [ Time Frame: 12 months ]
  5. Post-treatment complication [ Time Frame: 12 months ]
    Post-treatment complication grade≥3 according the National Cancer Institute Common Toxicity Criteria version 4 (NCI-CTC-v4)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03659123


Contacts
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Contact: David DAYDE +33.4.78.86.37.74 david.dayde@chu-lyon.fr
Contact: Nadjat MEDEGHRI : +33.4.78.86.37.74 nadjat.medeghri@chu-lyon.fr

Locations
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France
Centre Hospitalier de Chambéry Recruiting
Chambéry, France
Contact: Annyck MARION, MD         
Principal Investigator: Annyck MARION, MD         
Centre hospitalier de Givors Active, not recruiting
Givors, France
Centre Hospitalier Edouard Herriot Recruiting
Lyon, France
Contact: Elisabeth CASTEL-KREMER, MD    04 72 11 03 02 ext +33    elisabeth.castel-kremer@chu-lyon.fr   
Principal Investigator: Elisabeth CASTEL-KREMER, MD         
Hôpital Croix Rousse Recruiting
Lyon, France
Contact: Isabelle MOREL-SOLDNER, MD    04 72 14 14 85 ext +33    isabelle.morel-soldner@chu-lyon.fr   
Principal Investigator: Isabelle MOREL-SOLDNER, MD         
Centre hospitalier d'Annecy Genevois Recruiting
Metz-Tessy, France
Contact: Laetitia STEFANI, MD    04 50 63 66 08 ext +33    Istefani@ch-annecygenevois.fr   
Principal Investigator: Laetitia STEFANI, MD         
Centre Hospitalier Lyon Sud, Service d'Oncologie Médicale Recruiting
Pierre-Bénite, France
Contact: Olivia LESAUX, MD    04 78 86 37 75 ext +33    olivia.le-saux@chu-lyon.fr   
Principal Investigator: Olivia LESAUX, MD         
Centre Hospitalier Lyon Sud, Service de Gériatrie Recruiting
Pierre-Bénite, France
Contact: Claire FALANDRY, MD    04 78 86 32 87 ext +33    claire.falandry@chu-lyon.fr   
Principal Investigator: Claire FALANDRY, MD         
Centre hospitalier Universitaire de Saint Etienne Active, not recruiting
Saint-Étienne, France
Hôpital Nord-Ouest Recruiting
Villefranche-sur-Saône, France
Contact: Max HAINE, MD    04 74 09 27 82 ext +33    MHaine@lhopitalnordouest.fr   
Principal Investigator: Max HAINE, MD         
Clinique mutualiste Médipole Active, not recruiting
Villeurbanne, France
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Claire FALANDRY, MD Hospices Civils de Lyon
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03659123    
Other Study ID Numbers: 69HCL16_0701
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Elderly
Prehabilitation
Cancer
Surgery