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

Overview

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.

Interventions

• Behavioral 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

Primary outcome measures

• Objective measurement of physical activity (in MET-hr/week, Metabolic Equivalent of Task (MET), measures the intensity of physical activity) [Time frame: Month: 12]

Secondary outcome measures (12)

• Objective measurement of physical activity (in MET-hr/week, Metabolic Equivalent of Task (MET), measures intensity of physical activity) [Time frame: Inclusion, 3, 6 and 12 months]
• Objective measure of physical inactivity (in h/d) [Time frame: Inclusion, 3, 6 and 12 months]
• Subjective measurement of physical activity (in Metabolic equivalent of task-h/week) and sedentary time (h/d) [Time frame: Inclusion, 3, 6 and 12 months]
• Measurement of physical capacity: walking distance (meters) [Time frame: Inclusion, 3, 6 and 12 months]
• Measurement of muscle strength: biceps muscle strength (kg) [Time frame: Inclusion, 3, 6 and 12 months]
• Level of fatigue assessed by measuring heart rate variability (SDNN and RMSSD in ms) [Time frame: Inclusion, 3, 6 and 12 months]
• Level of fatigue [Time frame: Inclusion, 3, 6 and 12 months]
• Health-related quality of life [Time frame: Inclusion, 3, 6 and 12 months]
• Adoption of Acti-Pair program by physicians [Time frame: through end of inclusion, an average of 30 months]
• Adoption of Acti-Pair program by peers [Time frame: through end of inclusion, an average of 30 months]
• Adoption of Acti-Pair program by Adapted Physical Activity (APA) professionals [Time frame: through study completion, an average of 42 Months]
• Time dedicated by peers, Adapted Physical Activity (APA) professionals and health professionals to the Acti-Pair program [Time frame: through study completion, an average of 42 Months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

France · 25 centers

• Activité Physique Adaptée - CDOS Savoie — Chambéry
• CH Chambéry — Chambéry
• Activité Physique Adaptée - DAHLIR 63 — Clermont-Ferrand
• CHU Clermont-Ferrand - ONCOLOGIE — Clermont-Ferrand
• CHU Clermont-Ferrand - Urologie — Clermont-Ferrand
• Activité Physique Adaptée - CDOS Isère — Grenoble
• CHU Grenoble - Urologie — Grenoble
• Activité Physique Adaptée - DAHLIR 43 — Le Puy-en-Velay
• … and 17 more centers

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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 PMID 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. PMID 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. PMID 28829716

Identifiers

NCT: NCT05739565 · 20PH286 · 2022-A01094-39

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗