Clinical trial NCT05981170: Rurality Adapted Physical Activity Sport Health
Official title: To Evaluate the Impact of Home-based Adapted Physical Activity Programme for Patients With Brain Tumours and/or Metastatic Cancer Living in Rural Areas
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Tumour
Metastatic Cancer
Keywords: Adapted physical activity
Rurality
Oncology
Physical fitness
Supportive care
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated at the ICO Angers for a brain tumour and or metastatic cancer with medically measured APA needs.

Brief 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.

Eligibility 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

Primary outcomes:
measure: Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F)
timeFrame: Through study completion, an average 6 months.
Secondary outcomes:
measure: Short Physical Performance Battery test (SPPB)
timeFrame: Through studied intervention, an average 3 months.
measure: 6 minute walk test
timeFrame: Through studied intervention, an average 3 months.
measure: Hand grip test
timeFrame: Through studied intervention, an average 3 months.
measure: Flexibility test
timeFrame: Through studied intervention, an average 3 months.
measure: Balance test
timeFrame: Through studied intervention, an average 3 months.
measure: Ricci et Gagnon questionnaire
timeFrame: Through study completion, an average 6 months.
measure: The Patient Global Impression scale (P-GIC)
timeFrame: At the end of the APA sessions, on average 3 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancerologie de L'Ouest
Study officials:
affiliation: Institut de Cancérologie de l'Ouest
name: Loïc FAIVRE
role: PRINCIPAL_INVESTIGATOR
References: