Rurality Adapted Physical Activity Sport Health

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05981170
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Institut Cancerologie de l'Ouest
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Loïc FAIVRE
Principal Investigator Affiliation	Institut de Cancérologie de l'Ouest
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Tumour, Metastatic Cancer

Additional Details

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.

Contact a Trial Team

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