Clinical trial NCT05739565: Impact of a Physical Activity Intervention With Motivational Support From Peers for Prostate Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Physical activity
prostate cancer
interventional research
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Sport Health Center of Auvergne-Rhône Alpes
name: INSERM, SAINBIOSE U1059
name: Institut National de la Santé Et de la Recherche Médicale, France
name: INSERM ECEVE 1123
name: Ministry of Health, France
First posted: 2023-02-22
Enrollment: 850
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Objective measurement of physical activity (in MET-hr/week, Metabolic Equivalent of Task (MET), measures the intensity of physical activity)
timeFrame: Month: 12
Secondary outcomes:
measure: Objective measurement of physical activity (in MET-hr/week, Metabolic Equivalent of Task (MET), measures intensity of physical activity)
timeFrame: Inclusion, 3, 6 and 12 months
measure: Objective measure of physical inactivity (in h/d)
timeFrame: Inclusion, 3, 6 and 12 months
measure: Subjective measurement of physical activity (in Metabolic equivalent of task-h/week) and sedentary time (h/d)
timeFrame: Inclusion, 3, 6 and 12 months
measure: Measurement of physical capacity: walking distance (meters)
timeFrame: Inclusion, 3, 6 and 12 months
measure: Measurement of muscle strength: biceps muscle strength (kg)
timeFrame: Inclusion, 3, 6 and 12 months
measure: Level of fatigue assessed by measuring heart rate variability (SDNN and RMSSD in ms)
timeFrame: Inclusion, 3, 6 and 12 months
measure: Level of fatigue
timeFrame: Inclusion, 3, 6 and 12 months
measure: Health-related quality of life
timeFrame: Inclusion, 3, 6 and 12 months
measure: Adoption of Acti-Pair program by physicians
timeFrame: through end of inclusion, an average of 30 months
measure: Adoption of Acti-Pair program by peers
timeFrame: through end of inclusion, an average of 30 months
measure: Adoption of Acti-Pair program by Adapted Physical Activity (APA) professionals
timeFrame: through study completion, an average of 42 Months
measure: Time dedicated by peers, Adapted Physical Activity (APA) professionals and health professionals to the Acti-Pair program
timeFrame: through study completion, an average of 42 Months
measure: Assessment of the context:factors favoring and hindering implementation, achievement, adaptation and sustainability of the programme ; compliance with the programme ; social representations
timeFrame: Before and after the implementation of the intervention
measure: Percentage of adherence to the intervention
timeFrame: 12 months
measure: Motivation to engage in physical activity for patients and peers
timeFrame: Inclusion, 3, 6 and 12 months
measure: Alliance between the patient and the peer
timeFrame: 12 months
measure: Patients, peers and professionals satisfaction
timeFrame: 12 months
measure: Cost per quality adjusted life year (QALY) gained through the intervention (quality adjusted life year)
timeFrame: 12 months
measure: Cost per patient continuing physical activity at 12 months through the intervention
timeFrame: 12 months
Other outcomes:
Locations:
city: Chambéry
country: France
facility: Activité Physique Adaptée - CDOS Savoie
city: Chambéry
country: France
facility: CH Chambéry
city: Clermont-Ferrand
country: France
facility: Activité Physique Adaptée - DAHLIR 63
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand - ONCOLOGIE
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand - Urologie
city: Grenoble
country: France
facility: Activité Physique Adaptée - CDOS Isère
city: Grenoble
country: France
facility: CHU Grenoble - Urologie
city: Le Puy-en-Velay
country: France
facility: Activité Physique Adaptée - DAHLIR 43
city: Le Puy-en-Velay
country: France
facility: CH Le Puy en Velay
city: Lyon
country: France
facility: HCL - Hôpital Edouard Herriot
city: Lyon
country: France
facility: HCL - Hôpital Croix Rousse
city: Lyon
country: France
facility: Activité Physique Adaptée - DAHLIR 69
city: Lyon
country: France
facility: CLB - Oncologie
city: Lyon
country: France
facility: CLB - Radiothérapie
city: Lyon
country: France
facility: HCL - CH Lyon Sud
city: Privas
country: France
facility: Activité Physique Adaptée - CDOS Ardèche
city: Roanne
country: France
facility: CH Roanne
city: Saint-Priest-en-Jarez
country: France
facility: Clinique du parc
city: Saint-Étienne
country: France
facility: Activité Physique Adaptée - DAPAP 42
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne - Oncologie
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne - Radiothérapie
city: Saint-Étienne
country: France
facility: Hôpital Privé de la Loire
city: Valence
country: France
facility: Activité Physique Adaptée - CDOS Drôme
city: Valence
country: France
facility: Hôpitaux Drôme Nord - Valence
city: Valence
country: France
facility: Radiologie Drôme-Ardèche - Valence
Study officials:
affiliation: CHU de Saint-Etienne
name: David HUPIN, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.