Rurality Adapted Physical Activity Sport Health (RAPASS)

July 31, 2023 updated by: Institut Cancerologie de l'Ouest

To Evaluate the Impact of Home-based Adapted Physical Activity Programme for Patients With Brain Tumours and/or Metastatic Cancer Living in Rural Areas

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Loïc FAIVRE
Phone Number: +33 (0)2 41 35 27 00
Email: loic.faivre@ico.unicancer.fr

Study Locations

France
- - Angers, France, 49055
    - Institut de Cancérologie de l'Ouest
    - Contact:
      
      Loïc FAIVRE
      
      Phone Number: +33 (0)2 41 35 27 00
      
      Email: loic.faivre@ico.unicancer.fr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) Time Frame: 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.	Through study completion, an average 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Physical Performance Battery test (SPPB) Time Frame: 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	Through studied intervention, an average 3 months.
6 minute walk test Time Frame: 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	Through studied intervention, an average 3 months.
Hand grip test Time Frame: Through studied intervention, an average 3 months.	This test measures muscular health of the hands and forearms.	Through studied intervention, an average 3 months.
Flexibility test Time Frame: 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.	Through studied intervention, an average 3 months.
Balance test Time Frame: 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).	Through studied intervention, an average 3 months.
Ricci et Gagnon questionnaire Time Frame: 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	Through study completion, an average 6 months.
The Patient Global Impression scale (P-GIC) Time Frame: 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.	At the end of the APA sessions, on average 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Cancerologie de l'Ouest

Investigators

Principal Investigator: Loïc FAIVRE, Institut de Cancérologie de l'Ouest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

May 24, 2023

First Submitted That Met QC Criteria

July 31, 2023

First Posted (Actual)

August 8, 2023

Study Record Updates

Last Update Posted (Actual)