Trial Title:
Impact of a Physical Activity Intervention With Motivational Support From Peers for Prostate Cancer Patients
NCT ID:
NCT05739565
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Physical activity
prostate cancer
interventional research
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Acti-Pair program
Description:
Motivational support by the peer (a patient with the same pathology who meets the WHO
recommendations for physical activity), who will provide motivational follow-up
- The implementation of a personalized and realistic physical activity project for the
patient via the physical activity support systems (sport health centers)
- Support from health professionals (GP) via the prescription of physical activity and
from adapted physical activity (APA) professionals
Arm group label:
Acti-Pair program
Summary:
Despite the recognized benefits of physical activity in tertiary prevention, 60-70% of
prostate cancer patients are insufficiently active.
Yet 150 minutes of brisk walking per week (new WHO recommendations) is associated with a
29% reduction in cancer mortality and a 57% reduction in recurrence.
Increasing patients' adherence to regular physical activity appears to be a new challenge
for personalized cancer care.
Personalized physical activity programmes (1) at home, (2) supported by health
professionals, or (3) by peers have shown the effectiveness of regular physical activity.
However, these interventions last less than 6 months and do not allow for long-term
sustainability of physical activity.
This study proposes to combine 3 interventions, which aim to initiate and maintain
regular physical activity in prostate cancer patients:
- 1-The realization of a personalized and realistic physical activity project via
physical activity support devices (sport health centers)
- 2-Coaching by a peer (a patient with the same disease who has reached the WHO
recommendations for physical activity), who will provide motivational follow-up
- 3-Support by health professionals (attending physician) through the prescription of
physical activity.
The feasibility of ACTI-PAIR program has been demonstrated, the investigators now wish to
evaluate it effectiveness.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Patients:
- Age ≥ 18 years
- Diagnosed with prostate cancer for at least 1 year
- PA practice < 150 minutes per week (considered inactive according to WHO)
- Affiliated or entitled to a social security scheme
- Having received informed information about the study and having co-signed, with the
investigator, a consent to participate in the study
Exclusion Criteria:
For patients:
- Undergoing treatment (except hormone therapy)
- Significant comorbidities contraindicating the practice of physical activity:
associated cardiac pathologies, respiratory pathologies, disabling joint pathologies
- Deprived of liberty or under guardianship
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Activité Physique Adaptée - CDOS Savoie
Address:
City:
Chambéry
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Fabrice DESCOMBES, MD
Email:
Principal Investigator
Facility:
Name:
CH Chambéry
Address:
City:
Chambéry
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Guillaume MORICEAU, MD
Email:
Principal Investigator
Facility:
Name:
Activité Physique Adaptée - DAHLIR 63
Address:
City:
Clermont-Ferrand
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Joris MARTIN, MD
Email:
Principal Investigator
Facility:
Name:
CHU Clermont-Ferrand - ONCOLOGIE
Address:
City:
Clermont-Ferrand
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Aurore DOUGE
Investigator:
Last name:
Rémi FILLATRE
Email:
Sub-Investigator
Investigator:
Last name:
Julien PINOT
Email:
Sub-Investigator
Investigator:
Last name:
Sébastien BAILLY Sébastien
Email:
Sub-Investigator
Facility:
Name:
CHU Clermont-Ferrand - Urologie
Address:
City:
Clermont-Ferrand
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Laurent GUY
Investigator:
Last name:
Florian CERUTI, MD
Email:
Sub-Investigator
Investigator:
Last name:
Nicolas VEDRINE
Email:
Sub-Investigator
Investigator:
Last name:
Clémentine MILLET
Email:
Sub-Investigator
Investigator:
Last name:
Ludivine CAMBOU
Email:
Sub-Investigator
Investigator:
Last name:
Cyril CHARBONNEL
Email:
Sub-Investigator
Facility:
Name:
Activité Physique Adaptée - CDOS Isère
Address:
City:
Grenoble
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
MD
Investigator:
Last name:
Manon GIRARD, MD
Email:
Sub-Investigator
Investigator:
Last name:
Fanny BIZARD
Email:
Sub-Investigator
Investigator:
Last name:
Benjamin CASSEBRAS
Email:
Sub-Investigator
Investigator:
Last name:
Maëva MANUEL
Email:
Sub-Investigator
Investigator:
Last name:
Cécile GUIGUE
Email:
Sub-Investigator
Facility:
Name:
CHU Grenoble - Urologie
Address:
City:
Grenoble
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Jean-Luc DESCOTES, MD
Investigator:
Last name:
Jean-Luc DESCOTES, MD
Email:
Principal Investigator
Facility:
Name:
Activité Physique Adaptée - DAHLIR 43
Address:
City:
Le Puy-en-Velay
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Anaïs CHARRA, MD
Investigator:
Last name:
Anaïs CHARRA, MD
Email:
Principal Investigator
Facility:
Name:
CH Le Puy en Velay
Address:
City:
Le Puy-en-Velay
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Corinne BRUCHET, MD
Investigator:
Last name:
Corinne BRUCHET, MD
Email:
Principal Investigator
Facility:
Name:
HCL - Hôpital Edouard Herriot
Address:
City:
Lyon
Zip:
69000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Marc COLOMBEL, PhD
Investigator:
Last name:
Sébastien CROUZET
Email:
Sub-Investigator
Investigator:
Last name:
Ricardo CODAS DUARTE
Email:
Sub-Investigator
Investigator:
Last name:
Hakim FASSI-FEHRI
Email:
Sub-Investigator
Facility:
Name:
HCL - Hôpital Croix Rousse
Address:
City:
Lyon
Zip:
69004
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Claire FALANDRY, MD PhD
Email:
Principal Investigator
Facility:
Name:
Activité Physique Adaptée - DAHLIR 69
Address:
City:
Lyon
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Julie Julie, MD
Investigator:
Last name:
Julie Julie, MD
Email:
Principal Investigator
Facility:
Name:
CLB - Oncologie
Address:
City:
Lyon
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Cécile LAUDE, MD
Investigator:
Last name:
Cécile LAUDE, MD
Email:
Principal Investigator
Facility:
Name:
CLB - Radiothérapie
Address:
City:
Lyon
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Sofiane HANAYA, MD
Investigator:
Last name:
Sofiane HANAYA, MD
Email:
Principal Investigator
Facility:
Name:
HCL - CH Lyon Sud
Address:
City:
Lyon
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Alain RUFFION, MD
Investigator:
Last name:
Alain RUFFION, MD
Email:
Principal Investigator
Facility:
Name:
Activité Physique Adaptée - CDOS Ardèche
Address:
City:
Privas
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Jonathan BAZARD, MD
Email:
Principal Investigator
Facility:
Name:
CH Roanne
Address:
City:
Roanne
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Lionel VINCENT, MD
Investigator:
Last name:
Lionel VINCENT, MD
Email:
Principal Investigator
Facility:
Name:
Clinique du parc
Address:
City:
Saint-Priest-en-Jarez
Zip:
42270
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Hocine HABCHI, MD
Investigator:
Last name:
Amine MESSAOUD
Email:
Sub-Investigator
Facility:
Name:
Activité Physique Adaptée - DAPAP 42
Address:
City:
Saint-Étienne
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Maël GARROS, MD
Investigator:
Last name:
Maël GARROS, MD
Email:
Principal Investigator
Facility:
Name:
CHU Saint-Etienne - Oncologie
Address:
City:
Saint-Étienne
Country:
France
Status:
Recruiting
Contact:
Last name:
Pierre CORNILLON, MD
Investigator:
Last name:
Pierre CORNILLON, MD
Email:
Principal Investigator
Facility:
Name:
CHU Saint-Etienne - Radiothérapie
Address:
City:
Saint-Étienne
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Anne-Laure BAREILLE, MD
Investigator:
Last name:
Anne-Laure BAREILLE, MD
Email:
Principal Investigator
Facility:
Name:
Hôpital Privé de la Loire
Address:
City:
Saint-Étienne
Country:
France
Status:
Recruiting
Contact:
Last name:
Stéphane LORIN, MD
Investigator:
Last name:
Stéphane LORIN, MD
Email:
Principal Investigator
Investigator:
Last name:
Aline GUILLOT
Email:
Sub-Investigator
Investigator:
Last name:
Cécile VASSAL
Email:
Sub-Investigator
Facility:
Name:
Activité Physique Adaptée - CDOS Drôme
Address:
City:
Valence
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Aline CARLIER, MD
Email:
Principal Investigator
Facility:
Name:
Hôpitaux Drôme Nord - Valence
Address:
City:
Valence
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Thomas POLGUER, MD
Email:
Principal Investigator
Facility:
Name:
Radiologie Drôme-Ardèche - Valence
Address:
City:
Valence
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Jean-Baptiste GUY, MD
Email:
Principal Investigator
Investigator:
Last name:
Sébastien CLIPPE
Email:
Sub-Investigator
Investigator:
Last name:
Bertrand FLEURY
Email:
Sub-Investigator
Start date:
April 25, 2023
Completion date:
September 30, 2026
Lead sponsor:
Agency:
Centre Hospitalier Universitaire de Saint Etienne
Agency class:
Other
Collaborator:
Agency:
Sport Health Center of Auvergne-Rhône Alpes
Agency class:
Other
Collaborator:
Agency:
INSERM, SAINBIOSE U1059
Agency class:
Other
Collaborator:
Agency:
INSERM, CIC1408
Agency class:
Other
Collaborator:
Agency:
INSERM ECEVE 1123
Agency class:
Other
Collaborator:
Agency:
Ministry of Health, France
Agency class:
Other
Source:
Centre Hospitalier Universitaire de Saint Etienne
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05739565
