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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adapted physical activity program (APA Program) | Experimental | An intervention (APA program) will be offered to patients hospitalized in the conventional hospitalization department of the medical oncology department. At entry, after presenting the study and obtaining non-opposition from patients, an initial assessment will be carried out before the APA program. 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adapted physical activity program (APA Program) | Other | Content of the APA program:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | The main objective of the study is to validate that the proportion of patients having completed, from inclusion (D0), at least three supervised APA sessions of a minimum duration of 15 minutes, during the first 7 consecutive days of his hospitalization (P) is beyond a threshold considered uninteresting of 50% (P0) To test the following hypotheses: H0: a compliant patient rate <= 50% is uninteresting (P<=P0) H1: a compliant patient rate > 80% is expected (P>P1) With an A'Hern type design, a one-sided alpha risk of 2.5% and a power of 90%, it is required to include 28 evaluable patients in the study to test H0 vs H1. Considering a rate of unevaluable patients of 10% it will be necessary to include 32 patients. Hypothesis H0 will be rejected if 20 (71.4%) or more than 20 patients out of the first 28 evaluable are compliant. | 7 days after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Describe the evolution of body composition measured by impedancemetry |
| At inclusion (day 1) and at the study completion, an average of 15 days |
| Describe the evolution of physical parameters functional capacities |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quentin JACQUINOT, Dr | Contact | 0370632058 | qjacquinot@irfc-fc.fr |
| Name | Affiliation | Role |
|---|---|---|
| Quentin JACQUINOT, Dr | CHU Besançon | Principal Investigator |
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|
- Score of Short Physical Performance Battery Test (Score of 0 =Faible performance to 12= Haute performance) |
| At inclusion (day 1) and at the study completion, an average of 15 days |
| Describe the evolution of autonomy in daily life activities | IADL Questionnaire IADL score 0 to 4
| At inclusion (day 1) and at the study completion, an average of 15 days |
| Describe the evolution of muscular strength | Handgrip :results in kilograms | At inclusion (day 1) and at the study completion, an average of 15 days |
| Describe the evolution of the quality of life | QLQ-C30 questionnaire All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. | At inclusion (day 1) and at the study completion, an average of 15 days |
| Describe the evolution of motivation to practice physical activity | Questionnaire BREQ-2 The BREQ-2 is a 19 item questionnaire that measures the stages of the self-determination continuum with respect to motivation to exercise with a 5 point Likert scale (0=not true for me, 4=very true for me) | At inclusion (day 1) and at the study completion, an average of 15 days |
| Tolerance with the APA program on perception of effort | Perception of effort with te Borg scale CR10. Scale of 0 (No exertion at all) to 10 (representing an extreme intensity of activity) | immediately after each intervention session |
| Tolerance with the APA program on pain and fatigue | Visual analog scale (0 = no pain and 10 = very severe pain) | Immediately before and after each intervention session |
| Tolerance with the APA program on fatigue | Visual analog scale (0 = no fatigue and 10 = very severe fatigue) | Immediately before and after each intervention session |
| Compliance with the APA program | Number of sessions carried out out of the number planned | at the study completion, an average of 15 days |
| Criteria/reasons for non-participation, non-compliance, discontinuation of the intervention and study withdrawals | at the study completion, an average of 15 days |
| Patient satisfaction | Likert scale (0= unsatisfiedt o 5 =very satisfied) | at the study completion, an average of 15 days |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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