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Trial Title:
Rurality Adapted Physical Activity Sport Health
NCT ID:
NCT05981170
Condition:
Brain Tumour
Metastatic Cancer
Conditions: Official terms:
Brain Neoplasms
Neoplasm Metastasis
Conditions: Keywords:
Adapted physical activity
Rurality
Oncology
Physical fitness
Supportive care
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Adapted physical activity at home
Description:
The programme will take place over 6 months and will include :
1 consultation with the oncologist who will first assess the need for Adapted Physical
Activity and then prescribe the APA with a certificate of no physical contraindication
1 consultation with the ICO's APA coach who will present the APA programme and assess the
patient's physical capacity using the Short Physical Performance Battery (SPPB) test in
order to adapt the programme to their needs.
13 home-based APA sessions (ideally one session per week) with the EAPA from Departmental
Committee for Sport for All in 49
1 telephone call with the EAPA of the ICO to evaluate the programme 3 months after the
last session.
Patients will also be asked to complete questionnaires at the first session (S1), halfway
through the sessions (S6) and at the last session (S13).
These are FACIT-F 5Functional Assessment of Chronic Illness Therapy - Fatigue ; Ricci and
L. Gagnon ; P-GIC (Patients' Global Impression of Change (PGIC) scale)
Summary:
Physical activity (PA) has been an integral part of non-drug therapy since the early
2010s. This supportive care is likely to reduce fatigue and improve the quality of life
of patients during and after the cancer treatment phase.
Physical activity also has a protective effect in terms of tertiary prevention by
reducing the risk of recurrence of certain cancers (breast, colon, prostate) by around 40
to 50% and by reducing overall mortality.
Adapted physical activity (APA) is offered at the Institut de Cancérologie de l'Ouest
(ICO) in Angers, but there are obstacles particularly linked to the geographical distance
of the establishment where this activity is offered.
The RAPASS project is a prospective study which will be proposed to patients followed at
the ICO, living in rural areas and far from Angers. Its main objective is to describe the
fatigue and quality of life of patients before, during and after a 13-session home-based
APA programme. The data collected will also be used to describe changes in physical
condition and level, compliance with the programme, continuation of physical activity
beyond the duration of the programme, and satisfaction.
Detailed description:
The oncologist first assesses the patient's need for APA. The patient is then seen by the
ICO's APA coach (EAPA) who presents the APA programme. If the patient agrees to
participate, the coach assesses the patient's physical capacity in order to adapt the
programme to their needs.
The programme is then carried out with the departmental sports for all committee 49.
The frequency of practice will ideally be one session per week at the patient's home,
supervised by a coach from Departmental Committee for Sport for All in 49. A total of 13
sessions will be carried out.
The sessions will aim to develop all the components of physical fitness (endurance,
strength, balance, flexibility, coordination, etc.).
The patient receives a walking logbook to record the number of daily steps taken, an
exercise booklet to work independently and a pedometer.
In the presence of the coach, the patients perform different exercises and complete
different questionnaires.
The programme is evaluated by the ICO EAPA 3 months after the 13th and final session.
Criteria for eligibility:
Study pop:
Patients treated at the ICO Angers for a brain tumour and or metastatic cancer with
medically measured APA needs.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Performans Status ≤ 2
- Patient living in a rural area
- Patient with a brain tumour and/or metastatic cancer
- Patient with a medical prescription for APA practice
- Patient with a certificate of no contraindication to physical activity
Exclusion Criteria:
- Persons deprived of their liberty, under court protection, under guardianship or
under the authority of a guardian
- Patient unable to undergo the trial procedures for social or psychological reasons
- Patient who does not understand French
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut de Cancerologie de L'Ouest
Address:
City:
Angers
Zip:
49055
Country:
France
Contact:
Last name:
Loïc FAIVRE
Phone:
(0)2 41 35 27 00
Phone ext:
+33
Email:
loic.faivre@ico.unicancer.fr
Start date:
September 2023
Completion date:
March 2025
Lead sponsor:
Agency:
Institut Cancerologie de l'Ouest
Agency class:
Other
Source:
Institut Cancerologie de l'Ouest
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05981170