Impact of a Physical Activity Intervention With Motivational Support From Peers for Prostate Cancer Patients

NCT ID: NCT05739565

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

850 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-25

Study Completion Date

2028-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Acti-Pair program

* 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

Group Type EXPERIMENTAL

Acti-Pair program

Intervention Type BEHAVIORAL

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

The 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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acti-Pair program

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Sport Health Center of Auvergne-Rhône Alpes

UNKNOWN

Sponsor Role collaborator

INSERM, SAINBIOSE U1059

UNKNOWN

Sponsor Role collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

INSERM ECEVE 1123

UNKNOWN

Sponsor Role collaborator

Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David HUPIN, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

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Activité Physique Adaptée - CDOS Savoie

Chambéry, , France

Site Status NOT_YET_RECRUITING

CH Chambéry

Chambéry, , France

Site Status NOT_YET_RECRUITING

Activité Physique Adaptée - DAHLIR 63

Clermont-Ferrand, , France

Site Status NOT_YET_RECRUITING

CHU Clermont-Ferrand - ONCOLOGIE

Clermont-Ferrand, , France

Site Status NOT_YET_RECRUITING

CHU Clermont-Ferrand - Urologie

Clermont-Ferrand, , France

Site Status NOT_YET_RECRUITING

Activité Physique Adaptée - CDOS Isère

Grenoble, , France

Site Status NOT_YET_RECRUITING

CHU Grenoble - Urologie

Grenoble, , France

Site Status NOT_YET_RECRUITING

Activité Physique Adaptée - DAHLIR 43

Le Puy-en-Velay, , France

Site Status NOT_YET_RECRUITING

CH Le Puy en Velay

Le Puy-en-Velay, , France

Site Status NOT_YET_RECRUITING

HCL - Hôpital Edouard Herriot

Lyon, , France

Site Status NOT_YET_RECRUITING

HCL - Hôpital Croix Rousse

Lyon, , France

Site Status NOT_YET_RECRUITING

Activité Physique Adaptée - DAHLIR 69

Lyon, , France

Site Status NOT_YET_RECRUITING

CLB - Oncologie

Lyon, , France

Site Status NOT_YET_RECRUITING

CLB - Radiothérapie

Lyon, , France

Site Status NOT_YET_RECRUITING

HCL - CH Lyon Sud

Lyon, , France

Site Status NOT_YET_RECRUITING

Activité Physique Adaptée - CDOS Ardèche

Privas, , France

Site Status NOT_YET_RECRUITING

CH Roanne

Roanne, , France

Site Status NOT_YET_RECRUITING

Activité Physique Adaptée - DAPAP 42

Saint-Etienne, , France

Site Status NOT_YET_RECRUITING

CHU Saint-Etienne - Oncologie

Saint-Etienne, , France

Site Status RECRUITING

CHU Saint-Etienne - Radiothérapie

Saint-Etienne, , France

Site Status NOT_YET_RECRUITING

Hôpital Privé de la Loire

Saint-Etienne, , France

Site Status RECRUITING

Clinique du parc

Saint-Priest-en-Jarez, , France

Site Status NOT_YET_RECRUITING

Activité Physique Adaptée - CDOS Drôme

Valence, , France

Site Status NOT_YET_RECRUITING

Hôpitaux Drôme Nord - Valence

Valence, , France

Site Status NOT_YET_RECRUITING

Radiologie Drôme-Ardèche - Valence

Valence, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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HUPIN DAVID, MD

Role: CONTACT

(0)477828413 ext. +33

Amandine BAUDOT, CRA

Role: CONTACT

(0)477829450 ext. +33

Facility Contacts

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Aurore DOUGE

Role: primary

Laurent GUY

Role: primary

MD

Role: primary

Jean-Luc DESCOTES, MD

Role: primary

Anaïs CHARRA, MD

Role: primary

Corinne BRUCHET, MD

Role: primary

Marc COLOMBEL, PhD

Role: primary

Julie Julie, MD

Role: primary

Cécile LAUDE, MD

Role: primary

Sofiane HANAYA, MD

Role: primary

Alain RUFFION, MD

Role: primary

Lionel VINCENT, MD

Role: primary

Maël GARROS, MD

Role: primary

Pierre CORNILLON, MD

Role: primary

Anne-Laure BAREILLE, MD

Role: primary

Stéphane LORIN, MD

Role: primary

Hocine HABCHI, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 25527697 (View on PubMed)

Richman 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.

Reference Type BACKGROUND
PMID: 21610110 (View on PubMed)

Phillips 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.

Reference Type BACKGROUND
PMID: 25876555 (View on PubMed)

Steindorf 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.

Reference Type BACKGROUND
PMID: 31720802 (View on PubMed)

Blaney 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.

Reference Type BACKGROUND
PMID: 23296635 (View on PubMed)

Livingston 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.

Reference Type BACKGROUND
PMID: 25877784 (View on PubMed)

Tudor-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.

Reference Type BACKGROUND
PMID: 19842459 (View on PubMed)

Buman 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.

Reference Type BACKGROUND
PMID: 28829716 (View on PubMed)

Pinto 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.

Reference Type BACKGROUND
PMID: 25110844 (View on PubMed)

Galvao 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.

Reference Type BACKGROUND
PMID: 28685892 (View on PubMed)

Baudot 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.

Reference Type BACKGROUND
PMID: 35063040 (View on PubMed)

Baudot 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.

Reference Type DERIVED
PMID: 39717077 (View on PubMed)

Other Identifiers

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2022-A01094-39

Identifier Type: OTHER

Identifier Source: secondary_id

20PH286

Identifier Type: -

Identifier Source: org_study_id

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