Clinical trial NCT06321744: Study Evaluating the Feasibility of an Adapted Physical Activity Program During the Hospitalization Phase in Cancer Patients Undergoing Treatment
Official title: Study Evaluating the Feasibility of an Adapted Physical Activity Program During the Hospitalization Phase in Cancer Patients Undergoing Treatment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Physical exercise
cancer
hospitalization
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a non-randomized, non-controlled feasibility study which will take place at the Besançon University Hospital in the conventional hospitalization department.

It will be carried out with patients hospitalized in the conventional hospitalization department of the medical oncology department of Besançon University Hospital.

At entry, after presenting the study and obtaining non-opposition from patients, an initial assessment will be carried out before the APA program. This assessment will include an evaluation of physical parameters (measurements of body composition, functional capacities, autonomy in activities of daily living and muscular strength), as well as an evaluation of quality of life relating to health and motivation to practice physical activity.

At the end of the initial assessment, an APA program supervised (individually and in a room) by an APA teacher will be offered to patients. The sessions will be offered daily to patients (maximum 5 times/week). They will last on average 20 minutes each depending on the fatigue, pain and fitness of the patients. The objectives pursued are mainly an improvement in functional independence and mobility.


Eligibility criteria: Inclusion Criteria:

* Man or woman aged 18 and over (no age limit)
* Patient followed for cancer,
* Patients with no medical contraindication to adapted physical activity (certificate)
* Patient with a performance index status less than 4
* Patient hospitalized in the conventional medical oncology hospitalization department of Besançon University Hospital.
* Patient not opposed to participating in the study
* Patient affiliated to a French social security scheme or beneficiary of such a scheme.
* For women: menopausal for at least 24 months, surgically sterilized, or, for women of childbearing age, use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double-barrier method, patches contraceptives)
* Length of hospitalization estimated at at least 7 days (main objective) and with the patient's objective of returning home or to SSR in the long term

Exclusion Criteria:

* Patient with an absolute medical contraindication to adapted physical activity
* Patient with inability to understand instructions and complete questionnaires.
* Patient with a performance index status of 4
* Patient with legal incapacity or limited legal capacity
* Patient unlikely to cooperate in the study and/or low cooperation anticipated by the investigator
* Patient without health insurance
* Pregnant woman
* Patient being in the exclusion period of another study or provided for by the "national volunteer file".

Primary outcomes:
measure: Validate the feasibility of a supervised adapted physical activity (APA) program during the first 7 days of hospitalization in medical oncology for patients with cancer undergoing treatment
timeFrame: 7 days after inclusion
Secondary outcomes:
measure: Describe the evolution of body composition measured by impedancemetry
timeFrame: At inclusion (day 1) and at the study completion, an average of 15 days
measure: Describe the evolution of physical parameters functional capacities
timeFrame: At inclusion (day 1) and at the study completion, an average of 15 days
measure: Describe the evolution of autonomy in daily life activities
timeFrame: At inclusion (day 1) and at the study completion, an average of 15 days
measure: Describe the evolution of muscular strength
timeFrame: At inclusion (day 1) and at the study completion, an average of 15 days
measure: Describe the evolution of the quality of life
timeFrame: At inclusion (day 1) and at the study completion, an average of 15 days
measure: Describe the evolution of motivation to practice physical activity
timeFrame: At inclusion (day 1) and at the study completion, an average of 15 days
measure: Tolerance with the APA program on perception of effort
timeFrame: immediately after each intervention session
measure: Tolerance with the APA program on pain and fatigue
timeFrame: Immediately before and after each intervention session
measure: Tolerance with the APA program on fatigue
timeFrame: Immediately before and after each intervention session
measure: Compliance with the APA program
timeFrame: at the study completion, an average of 15 days
measure: Criteria/reasons for non-participation, non-compliance, discontinuation of the intervention and study withdrawals
timeFrame: at the study completion, an average of 15 days
measure: Patient satisfaction
timeFrame: at the study completion, an average of 15 days
Other outcomes:
Locations:
Study officials:
affiliation: CHU Besançon
name: Quentin JACQUINOT, Dr
role: PRINCIPAL_INVESTIGATOR
References: