Impact of a Physical Activity Intervention With Motivational Support From Peers for Prostate Cancer Patients
ACTI-PAIR2
Title Impact of a Physical Activity Intervention With Motivational Support From Peers for Prostate Cancer Patients - ACTI-PAIR 2 Multicenter, Randomized Stepped-wedge Study
2 other identifiers
interventional
850
1 country
25
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable prostate-cancer
Started Apr 2023
Typical duration for not_applicable prostate-cancer
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2023
CompletedFirst Posted
Study publicly available on registry
February 22, 2023
CompletedStudy Start
First participant enrolled
April 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2028
November 24, 2025
November 1, 2025
4.4 years
January 26, 2023
November 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective measurement of physical activity (in MET-hr/week, Metabolic Equivalent of Task (MET), measures the intensity of physical activity)
via actimetry (Actigraph GT9x, Pensacola, Florida, USA) 12 months (+/- 1 month) after the patient's inclusion in the Acti-Pair program
Month: 12
Secondary Outcomes (19)
Objective measurement of physical activity (in MET-hr/week, Metabolic Equivalent of Task (MET), measures intensity of physical activity)
Inclusion, 3, 6 and 12 months
Objective measure of physical inactivity (in h/d)
Inclusion, 3, 6 and 12 months
Subjective measurement of physical activity (in Metabolic equivalent of task-h/week) and sedentary time (h/d)
Inclusion, 3, 6 and 12 months
Measurement of physical capacity: walking distance (meters)
Inclusion, 3, 6 and 12 months
Measurement of muscle strength: biceps muscle strength (kg)
Inclusion, 3, 6 and 12 months
- +14 more secondary outcomes
Study Arms (2)
Acti-Pair program
EXPERIMENTAL* 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
Usual care
NO INTERVENTIONThe control group will be made up of patients followed up for prostate cancer and benefiting from usual care which consists of giving advice and recommendations for physical activity in consultation, aiming to make patients more active in their daily lives (=usual practice, physical activity to be carried out independently, at home).
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Hospitalier Universitaire de Saint Etiennelead
- Sport Health Center of Auvergne-Rhône Alpescollaborator
- INSERM, SAINBIOSE U1059collaborator
- Institut National de la Santé Et de la Recherche Médicale, Francecollaborator
- INSERM ECEVE 1123collaborator
- Ministry of Health, Francecollaborator
Study Sites (25)
Activité Physique Adaptée - CDOS Savoie
Chambéry, France
CH Chambéry
Chambéry, France
Activité Physique Adaptée - DAHLIR 63
Clermont-Ferrand, France
CHU Clermont-Ferrand - ONCOLOGIE
Clermont-Ferrand, France
CHU Clermont-Ferrand - Urologie
Clermont-Ferrand, France
Activité Physique Adaptée - CDOS Isère
Grenoble, France
CHU Grenoble - Urologie
Grenoble, France
Activité Physique Adaptée - DAHLIR 43
Le Puy-en-Velay, France
CH Le Puy en Velay
Le Puy-en-Velay, France
HCL - Hôpital Edouard Herriot
Lyon, 69000, France
HCL - Hôpital Croix Rousse
Lyon, 69004, France
Activité Physique Adaptée - DAHLIR 69
Lyon, France
CLB - Oncologie
Lyon, France
CLB - Radiothérapie
Lyon, France
HCL - CH Lyon Sud
Lyon, France
Activité Physique Adaptée - CDOS Ardèche
Privas, France
CH Roanne
Roanne, France
Activité Physique Adaptée - DAPAP 42
Saint-Etienne, France
CHU Saint-Etienne - Oncologie
Saint-Etienne, France
CHU Saint-Etienne - Radiothérapie
Saint-Etienne, France
Hôpital Privé de la Loire
Saint-Etienne, France
Clinique du parc
Saint-Priest-en-Jarez, 42270, France
Activité Physique Adaptée - CDOS Drôme
Valence, France
Hôpitaux Drôme Nord - Valence
Valence, France
Radiologie Drôme-Ardèche - Valence
Valence, France
Related Publications (12)
Bonn SE, Sjolander A, Lagerros YT, Wiklund F, Stattin P, Holmberg E, Gronberg H, Balter K. Physical activity and survival among men diagnosed with prostate cancer. Cancer Epidemiol Biomarkers Prev. 2015 Jan;24(1):57-64. doi: 10.1158/1055-9965.EPI-14-0707. Epub 2014 Dec 19.
PMID: 25527697BACKGROUNDRichman EL, Kenfield SA, Stampfer MJ, Paciorek A, Carroll PR, Chan JM. Physical activity after diagnosis and risk of prostate cancer progression: data from the cancer of the prostate strategic urologic research endeavor. Cancer Res. 2011 Jun 1;71(11):3889-95. doi: 10.1158/0008-5472.CAN-10-3932. Epub 2011 May 24.
PMID: 21610110BACKGROUNDPhillips SM, Stampfer MJ, Chan JM, Giovannucci EL, Kenfield SA. Physical activity, sedentary behavior, and health-related quality of life in prostate cancer survivors in the health professionals follow-up study. J Cancer Surviv. 2015 Sep;9(3):500-11. doi: 10.1007/s11764-015-0426-2. Epub 2015 Apr 16.
PMID: 25876555BACKGROUNDSteindorf K, Depenbusch J, Haussmann A, Tsiouris A, Schmidt L, Hermann S, Sieverding M, Wiskemann J, Ungar N. Change patterns and determinants of physical activity differ between breast, prostate, and colorectal cancer patients. Support Care Cancer. 2020 Jul;28(7):3207-3218. doi: 10.1007/s00520-019-05097-1. Epub 2019 Nov 13.
PMID: 31720802BACKGROUNDBlaney JM, Lowe-Strong A, Rankin-Watt J, Campbell A, Gracey JH. Cancer survivors' exercise barriers, facilitators and preferences in the context of fatigue, quality of life and physical activity participation: a questionnaire-survey. Psychooncology. 2013 Jan;22(1):186-94. doi: 10.1002/pon.2072. Epub 2011 Oct 6.
PMID: 23296635BACKGROUNDLivingston PM, Craike MJ, Salmon J, Courneya KS, Gaskin CJ, Fraser SF, Mohebbi M, Broadbent S, Botti M, Kent B; ENGAGE Uro-Oncology Clinicians' Group. Effects of a clinician referral and exercise program for men who have completed active treatment for prostate cancer: A multicenter cluster randomized controlled trial (ENGAGE). Cancer. 2015 Aug 1;121(15):2646-54. doi: 10.1002/cncr.29385. Epub 2015 Apr 15.
PMID: 25877784BACKGROUNDTudor-Locke C, Lauzon N, Myers AM, Bell RC, Chan CB, McCargar L, Speechley M, Rodger NW. Effectiveness of the First step Program delivered by professionals versus peers. J Phys Act Health. 2009 Jul;6(4):456-62. doi: 10.1123/jpah.6.4.456.
PMID: 19842459BACKGROUNDBuman MP, Giacobbi PR Jr, Dzierzewski JM, Morgan AA, McCrae CS, Roberts BL, Marsiske M. Peer Volunteers Improve Long-Term Maintenance of Physical Activity With Older Adults: A Randomized Controlled Trial. J Phys Act Health. 2011 Sep;8(s2):S257-S266. doi: 10.1123/jpah.8.s2.s257.
PMID: 28829716BACKGROUNDPinto BM, Stein K, Dunsiger S. Peers promoting physical activity among breast cancer survivors: A randomized controlled trial. Health Psychol. 2015 May;34(5):463-72. doi: 10.1037/hea0000120. Epub 2014 Aug 11.
PMID: 25110844BACKGROUNDGalvao DA, Newton RU, Girgis A, Lepore SJ, Stiller A, Mihalopoulos C, Gardiner RA, Taaffe DR, Occhipinti S, Chambers SK. Randomized controlled trial of a peer led multimodal intervention for men with prostate cancer to increase exercise participation. Psychooncology. 2018 Jan;27(1):199-207. doi: 10.1002/pon.4495. Epub 2017 Jul 27.
PMID: 28685892BACKGROUNDBaudot A, Barth N, Colas C, Garros M, Garcin A, Oriol M, Roche F, Chauvin F, Mottet N, Hupin D; on behalf the Acti-Pair investigators. The physical activity experience of prostate cancer patients: a multicentre peer motivation monitoring feasibility study. The Acti-Pair study. Pilot Feasibility Stud. 2022 Jan 21;8(1):12. doi: 10.1186/s40814-022-00966-9.
PMID: 35063040BACKGROUNDBaudot A, Fayolle E, Garros M, Barth N, Colin F, Presles E, Oriol M, Collange F, Chauvin F, Bourmaud A, Hupin D. Impact of the Acti-Pair programme on physical activity in patients with prostate cancer: protocol of the Acti-Pair 2 stepped-wedge cluster randomised trial. BMJ Open Sport Exerc Med. 2024 Dec 22;10(4):e002344. doi: 10.1136/bmjsem-2024-002344. eCollection 2024.
PMID: 39717077DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David HUPIN, MD PhD
CHU de Saint-Etienne
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2023
First Posted
February 22, 2023
Study Start
April 25, 2023
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
September 30, 2028
Last Updated
November 24, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share