Rurality Adapted Physical Activity Sport Health

NCT05981170 | Unknown

• 1 other identifier: ICO-2022-20
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumour; Metastatic Cancer

Keywords

Adapted physical activity; Rurality; Oncology; Physical fitness; Supportive care

Outcome Measures

Primary Outcomes (1)

• Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F)

  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 Outcomes (7)

• Short Physical Performance Battery test (SPPB)

  Through studied intervention, an average 3 months.

• 6 minute walk test

  Through studied intervention, an average 3 months.

• Hand grip test

  Through studied intervention, an average 3 months.

• Flexibility test

  Through studied intervention, an average 3 months.

• Balance test

  Through studied intervention, an average 3 months.

Interventions

Adapted physical activity at home OTHER

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (1)

Institut de Cancerologie de L'Ouest

Angers, 49055, France

Location

MeSH Terms

Conditions

Brain Neoplasms; Neoplasm Metastasis; Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Loïc FAIVRE

  Institut de Cancérologie de l'Ouest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Loïc FAIVRE

CONTACT

(0)2 41 35 27 00; loïc.faivre@ico.unicancer.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: August 8, 2023
• Study Start: September 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: August 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)