Brain TumourRAPASSNCT05981170
Rurality Adapted Physical Activity Sport Health
An observational study of Brain Tumour and Metastatic Cancer, run by Institut Cancerologie de l'Ouest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumour, Metastatic Cancer
- What is being tested?
- Adapted physical activity at home
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2023to Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated at the ICO Angers for a brain tumour and or metastatic cancer with medically measured APA needs.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site
Institut de Cancerologie de L'Ouest
Angers, 49055
Loïc FAIVRE, (0)2 41 35 27 00 ext. +33, loic.faivre@ico.unicancer.fr
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Brain Tumour, Metastatic Cancer
- Being tested
- Adapted physical activity at home
- Keywords
- Adapted physical activity, Rurality, Oncology, Physical fitness, Supportive care
- Medical subject headings
- Brain Neoplasms, Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted physical activity at homeOther
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average 6 months.
Secondary outcomes (7)
Short Physical Performance Battery test (SPPB)
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
Measured: Through studied intervention, an average 3 months.
6 minute walk test
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
Measured: Through studied intervention, an average 3 months.
Hand grip test
This test measures muscular health of the hands and forearms.
Measured: Through studied intervention, an average 3 months.
Flexibility test
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.
Measured: Through studied intervention, an average 3 months.
Balance test
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).
Measured: Through studied intervention, an average 3 months.
Ricci et Gagnon questionnaire
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
Measured: Through study completion, an average 6 months.
The Patient Global Impression scale (P-GIC)
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.
Measured: At the end of the APA sessions, on average 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study startSep 2023 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumourStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loïc FAIVRE, Principal investigator, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981170
- Sponsor's protocol ID
- ICO-2022-20
- Acronym
- RAPASS
- Status last verified
- May 2023
- First submitted
- 24 May 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05981170
- Acronym / sponsor ID
- RAPASS / ICO-2022-20
- Conditions
- Brain Tumour, Metastatic Cancer
- Keywords
- Adapted physical activity, Rurality, Oncology, Physical fitness, Supportive care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated at the ICO Angers for a brain tumour and or metastatic cancer with medically measured APA needs.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted physical activity at homeThe 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) | Other | – |
Primary outcome
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.
7 secondary outcomes
Short Physical Performance Battery test (SPPB)
Time frame: Through studied intervention, an average 3 months.
6 minute walk test
Time frame: Through studied intervention, an average 3 months.
Hand grip test
Time frame: Through studied intervention, an average 3 months.
Flexibility test
Time frame: Through studied intervention, an average 3 months.
Balance test
Time frame: Through studied intervention, an average 3 months.
Ricci et Gagnon questionnaire
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loïc FAIVRE principal investigator
Institut de Cancérologie de l'Ouest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumour and Metastatic Cancer, run by Institut Cancerologie de l'Ouest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Loïc FAIVRE ((0)2 41 35 27 00 ext. +33, loïc.faivre@ico.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) (time frame: Through study completion, an average 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.