RAPASS: Rurality Adapted Physical Activity Sport Health

Sponsor

Institut Cancerologie de l'Ouest (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05981170

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Tumour Metastatic Cancer	Other: Adapted physical activity at home

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

10 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 1, 2025

Outcome Measures

Primary Outcome Measures

Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) [Through study completion, an average 6 months.]
To describe the fatigue (physical, functional, social, emotional components) of patients. The Score from FACIT-F range from 0 to 52. The higher the score, the lower is the fatigue.

Secondary Outcome Measures

Short Physical Performance Battery test (SPPB) [Through studied intervention, an average 3 months.]
It is used to assess the physical performance of an individual. It is the result of the scores of three criteria: the balance test, the walking speed test and the chair lift test. The sum of the scores of all the tests gives an overall performance score: SPPB 0-6: Poor performance SPPB 7-9: Intermediate performance SPPB 10-12: High performance
6 minute walk test [Through studied intervention, an average 3 months.]
This test measures the functional limitation by comparing the theoretical distance with the measured distance. The patient is asked to walk as far as possible within six minutes: Excellent functional mobility ≥91% of the theoretical distance Good functional mobility between 82% and 90% of the theoretical distance Moderate functional limitation between 74% and 82% of the theoretical distance Severe functional limitation ≤73% of the theoretical distance
Hand grip test [Through studied intervention, an average 3 months.]
This test measures muscular health of the hands and forearms.
Flexibility test [Through studied intervention, an average 3 months.]
The patient performs a standing trunk flexion with legs stretched. Depending on the area reached (hand touching the ground, kick, tibia, etc.), a score will be given on a scale of 1 to 5, which differs according to the patient's sex.
Balance test [Through studied intervention, an average 3 months.]
The patient is asked to stand on one leg for 1 minute with their eyes open. The best time is recorded and depending on the age and sex of the patient, his or her performance will be rated on a scale of 1 (very poor balance) to 4 (excellent balance).
Ricci et Gagnon questionnaire [Through study completion, an average 6 months.]
This questionnaire assesses the level of physical activity. A number of points ranging from 1 to 5 are assigned to each answer. The total sum of the points determines an overall score that classifies the patients into : Score < 18 : inactive 18 ≤ Score ≤ 35: active Score > 35: very active
The Patient Global Impression scale (P-GIC) [At the end of the APA sessions, on average 3 months]
Evaluates the patient's satisfaction with the implementation of a home-based APA programme. The questionnaire includes a single question asking the patient what change home-based APA has had on their overall quality of life. The patient is given 7 options from which to choose the one that best corresponds to the perceived change: Very strongly positive, Strongly positive, Slightly positive, No change, Slightly negative, Strongly negative, Very strongly negative.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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