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Completed

NCT Number: NCT03659123

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

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.

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Key information

Conditions

Old Injury Neoplasms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de Chambéry, Chambéry, France

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About this study

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:

  • before surgery: a prehabilitation of the patients including a nutritional, physical and educational preparation;
  • 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;
  • bridging and post-discharge interventions for hospital-to-home transition.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standardized geriatric intervention

Behavioral

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: PROADAPT

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Sep 6, 2018
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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