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Prostate CancerACTI-PAIR2NCT05739565

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

A study testing Acti-Pair program in people with Prostate Cancer, run by Centre Hospitalier Universitaire de Saint Etienne at 25 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Acti-Pair program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
850 participants
Where
25 sitesFrance
Study dates
25 Apr 2023to 30 Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

25 sites in 1 country. Contact the study team or a site near you to ask about taking part.

HUPIN DAVID, MD contact

(0)477828413 ext. +33

David.Hupin@chu-st-etienne.fr

Amandine BAUDOT, CRA contact

(0)477829450 ext. +33

amandine.baudot@chu-st-etienne.fr

25 sites in 1 country

France25 sites, 25 recruiting

  • Activité Physique Adaptée - CDOS Savoie

    Chambéry

    Fabrice DESCOMBES, MD

    Not yet recruiting

  • CH Chambéry

    Chambéry

    Guillaume MORICEAU, MD

    Not yet recruiting

  • Activité Physique Adaptée - DAHLIR 63

    Clermont-Ferrand

    Joris MARTIN, MD

    Not yet recruiting

  • CHU Clermont-Ferrand - ONCOLOGIE

    Clermont-Ferrand

    Aurore DOUGE

    Rémi FILLATRE

    Not yet recruiting

  • CHU Clermont-Ferrand - Urologie

    Clermont-Ferrand

    Laurent GUY

    Florian CERUTI, MD

    Not yet recruiting

  • Activité Physique Adaptée - CDOS Isère

    Grenoble

    MD

    Manon GIRARD, MD

    Not yet recruiting

  • CHU Grenoble - Urologie

    Grenoble

    Jean-Luc DESCOTES, MD

    Jean-Luc DESCOTES, MD

    Not yet recruiting

  • Activité Physique Adaptée - DAHLIR 43

    Le Puy-en-Velay

    Anaïs CHARRA, MD

    Anaïs CHARRA, MD

    Not yet recruiting

  • CH Le Puy en Velay

    Le Puy-en-Velay

    Corinne BRUCHET, MD

    Corinne BRUCHET, MD

    Not yet recruiting

  • HCL - Hôpital Edouard Herriot

    Lyon, 69000

    Marc COLOMBEL, PhD

    Sébastien CROUZET

    Not yet recruiting

  • HCL - Hôpital Croix Rousse

    Lyon, 69004

    Claire FALANDRY, MD PhD

    Not yet recruiting

  • Activité Physique Adaptée - DAHLIR 69

    Lyon

    Julie Julie, MD

    Julie Julie, MD

    Not yet recruiting

  • CLB - Oncologie

    Lyon

    Cécile LAUDE, MD

    Cécile LAUDE, MD

    Not yet recruiting

  • CLB - Radiothérapie

    Lyon

    Sofiane HANAYA, MD

    Sofiane HANAYA, MD

    Not yet recruiting

  • HCL - CH Lyon Sud

    Lyon

    Alain RUFFION, MD

    Alain RUFFION, MD

    Not yet recruiting

  • Activité Physique Adaptée - CDOS Ardèche

    Privas

    Jonathan BAZARD, MD

    Not yet recruiting

  • CH Roanne

    Roanne

    Lionel VINCENT, MD

    Lionel VINCENT, MD

    Not yet recruiting

  • Activité Physique Adaptée - DAPAP 42

    Saint-Etienne

    Maël GARROS, MD

    Maël GARROS, MD

    Not yet recruiting

  • CHU Saint-Etienne - Oncologie

    Saint-Etienne

    Pierre CORNILLON, MD

    Pierre CORNILLON, MD

    Recruiting

  • CHU Saint-Etienne - Radiothérapie

    Saint-Etienne

    Anne-Laure BAREILLE, MD

    Anne-Laure BAREILLE, MD

    Not yet recruiting

  • Hôpital Privé de la Loire

    Saint-Etienne

    Stéphane LORIN, MD

    Stéphane LORIN, MD

    Recruiting

  • Clinique du parc

    Saint-Priest-en-Jarez, 42270

    Hocine HABCHI, MD

    Amine MESSAOUD

    Not yet recruiting

  • Activité Physique Adaptée - CDOS Drôme

    Valence

    Aline CARLIER, MD

    Not yet recruiting

  • Hôpitaux Drôme Nord - Valence

    Valence

    Thomas POLGUER, MD

    Not yet recruiting

  • Radiologie Drôme-Ardèche - Valence

    Valence

    Jean-Baptiste GUY, MD

    Sébastien CLIPPE

    Not yet recruiting

Other trials in France

About this study

Official title: Title Impact of a Physical Activity Intervention With Motivational Support From Peers for Prostate Cancer Patients - ACTI-PAIR 2 Multicenter, Randomized Stepped-wedge Study

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.

Read more

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.

Conditions
Prostate Cancer
Being tested
Acti-Pair program
Keywords
Physical activity, prostate cancer, interventional research
Medical subject headings
Prostatic Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acti-Pair programBehavioural

    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
Study groups in NCT05739565
Study groupRoleWhat they receive
Acti-Pair programExperimental* 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
Receives: Behavioral: Acti-Pair program
Usual careNo 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Month: 12

Secondary outcomes (19)

  1. Objective measurement of physical activity (in MET-hr/week, Metabolic Equivalent of Task (MET), measures intensity of physical activity)

    via actimetry (Actigraph GT9x, Pensacola, Florida, USA) (at 3 and 6 months).

    Measured: Inclusion, 3, 6 and 12 months

  2. Objective measure of physical inactivity (in h/d)

    via actimetry (Actigraph GT9x, Pensacola, Florida, USA)

    Measured: Inclusion, 3, 6 and 12 months

  3. Subjective measurement of physical activity (in Metabolic equivalent of task-h/week) and sedentary time (h/d)

    Via the e-Adult Physical Activity Questionnaire (e-APAQ, EA SNA-EPIS, University of Jean Monnet, Saint-Etienne, France) e-Adult Physical Activity Questionnaire (e-APAQ) assesses the 5 categories of physical activity (work, travel, daily life, leisure and sport) and daily life, leisure and sport). The minimum value is 1 and the maximum value is 300. More the physical activity score is high, more the patient is active. This questionnaire authenticates the periods of sedentarity (at work, during travel and daily life, leisure and sport). The minimum value is 1 and the maximum value is 24. More the sedentarity score is high, more the patient is sedentary.

    Measured: Inclusion, 3, 6 and 12 months

  4. Measurement of physical capacity: walking distance (meters)

    via the 6-minute walk test (6MWT).

    Measured: Inclusion, 3, 6 and 12 months

  5. Measurement of muscle strength: biceps muscle strength (kg)

    via the handgrip (JAMAR Hand Dynamometer, Nottingham, UK).

    Measured: Inclusion, 3, 6 and 12 months

  6. Level of fatigue assessed by measuring heart rate variability (SDNN and RMSSD in ms)

    via heart rate monitor connected to an actimeter (Actigraph GT3x, Pensacola, Florida, USA) for 24 hours

    Measured: Inclusion, 3, 6 and 12 months

  7. Level of fatigue

    via the FACIT-F questionnaire (Functional Assessment of Chronic Illness Therapy - Fatigue Scale). This questionnaire asseses fatigue and it impacts. The score range is 0 to 160. More the score is higher, more the fatigue is high.

    Measured: Inclusion, 3, 6 and 12 months

  8. Health-related quality of life

    via the EuroQol-5D questionnaire (EQ-5D-5L). The score range is -0.148 to 0.949. Mre the score is high, more the quality of life is good.

    Measured: Inclusion, 3, 6 and 12 months

  9. Adoption of Acti-Pair program by physicians

    Number of physicians including patients

    Measured: through end of inclusion, an average of 30 months

  10. Adoption of Acti-Pair program by peers

    Number of peers recruited

    Measured: through end of inclusion, an average of 30 months

  11. Adoption of Acti-Pair program by Adapted Physical Activity (APA) professionals

    Number of patients followed by APA professionals

    Measured: through study completion, an average of 42 Months

  12. Time dedicated by peers, Adapted Physical Activity (APA) professionals and health professionals to the Acti-Pair program

    Number of hours spend to follow-up patient specifically for the Acti-Pair program by peers, Adapted Physical Activity (APA) professionals and health professionals

    Measured: through study completion, an average of 42 Months

  13. Assessment of the context:factors favoring and hindering implementation, achievement, adaptation and sustainability of the programme ; compliance with the programme ; social representations

    Semi-structured interviews

    Measured: Before and after the implementation of the intervention

  14. Percentage of adherence to the intervention

    via the number of patients continuing the programme 12 months after initiation

    Measured: 12 months

  15. Motivation to engage in physical activity for patients and peers

    via the behavioural regulation in exercise questionnaire (BREQ-2). This questionnaire consists of 19 items includes 6 sub-scores of motivations : introjected regulation (3 items), external regulation (4 items), intrinsic regulation (4 items), integrated regulation, amotivation (4 items) and identified regulation (4 items) on a scale from 1 (Not at all true for me) to 5 (Absolutely true for me).

    Measured: Inclusion, 3, 6 and 12 months

  16. Alliance between the patient and the peer

    via the Working Alliance Inventory - short version (WAI-SR). This questionnaire measures three dimensions: bonding (development of a positive interpersonal attachment between the patient and the peer including mutual trust and respect), tasks (each partner's perception of the appropriateness and effectiveness of the care tasks, as well as tasks, as well as shared responsibility for their execution) and goals (understanding, validation and acceptance by both partners of the objectives of change in physical activity management).

    Patients rate items on a 5-point Likert scale anchored at each end with 'rarely or never' (1) and 'always' (5). The Goal, Task and Bond domains each have scores ranging from 5 to 20. Higher scores indicate a better therapeutic alliance.

    Measured: 12 months

  17. Patients, peers and professionals satisfaction

    Via a satisfaction questionnaire constructed for the Acti-Pair programme. The proposed responses are a likert scale ranging from Strongly Agree to Strongly Disagree. Each item will be described with a percentage of Likert scale for each response. More participants will fill out they have been strongly agree, more they will be satisfied.This questionnaire does not have a score.

    Measured: 12 months

  18. Cost per quality adjusted life year (QALY) gained through the intervention (quality adjusted life year)

    Quality of life data will be collected (e.g. quality of life using the EQ-5D-5L questionnaire, Appendix 3), transformed into utilities to calculate quality adjusted life year (QALY), and the number of patients continuing physical activity at 12 months. Cost data will be collected throughout the study, in each of the 8 departments involved. The analysis will be carried out from the payer's (health insurance) perspective. The time horizon will be that of the study (12 months), and therefore in accordance with French guidelines (HAS), no discount rate will be applied

    Measured: 12 months

  19. Cost per patient continuing physical activity at 12 months through the intervention

    The costs will include : - direct medical costs : health professionals consultations, peer-to-peer, patient sessions with APA professionals - indirect costs of implementing the intervention: training, facility rental operating costs, investment in small equipment

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2023
  2. Study start25 Apr 2023
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
850 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05739565
Sponsor's protocol ID
20PH286
Other IDs
2022-A01094-39
Acronym
ACTI-PAIR2
Status last verified
Nov 2025
First submitted
26 Jan 2023
Last updated
24 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25527697

  • 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.

    PubMed 21610110

  • 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.

    PubMed 25876555

  • 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.

    PubMed 31720802

  • 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.

    PubMed 23296635

  • 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.

    PubMed 25877784

  • 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.

    PubMed 19842459

  • 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.

    PubMed 28829716

  • 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.

    PubMed 25110844

  • 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.

    PubMed 28685892

  • 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.

    PubMed 35063040

  • 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.

    PubMed 39717077

Questions about this trial

What is this clinical trial studying?

A study testing Acti-Pair program in people with Prostate Cancer, run by Centre Hospitalier Universitaire de Saint Etienne at 25 sites 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact HUPIN DAVID, MD ((0)477828413 ext. +33, David.Hupin@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective measurement of physical activity (in MET-hr/week, Metabolic Equivalent of Task (MET), measures the intensity of physical activity) (time frame: Month: 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05739565, which also lists 12 linked publications.

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 24 Nov 2025.

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