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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A01094-39 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Sport Health Center of Auvergne-Rhône Alpes | UNKNOWN |
| INSERM, SAINBIOSE U1059 | UNKNOWN |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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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:
The feasibility of ACTI-PAIR program has been demonstrated, the investigators now wish to evaluate it effectiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acti-Pair program | Experimental |
|
|
| Usual care | No Intervention | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acti-Pair program | 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
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Inclusion, 3, 6 and 12 months |
| Objective measure of physical inactivity (in h/d) |
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Inclusion Criteria:
Patients:
Exclusion Criteria:
For patients:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HUPIN DAVID, MD | Contact | (0)477828413 | +33 | David.Hupin@chu-st-etienne.fr |
| Amandine BAUDOT, CRA | Contact | (0)477829450 | +33 | amandine.baudot@chu-st-etienne.fr |
| Name | Affiliation | Role |
|---|---|---|
| David HUPIN, MD PhD | CHU de Saint-Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Activité Physique Adaptée - CDOS Savoie | Not yet recruiting | Chambéry | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25527697 | Background | 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. | |
| 21610110 | Background | 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. |
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| INSERM ECEVE 1123 |
| UNKNOWN |
| Ministry of Health, France | OTHER_GOV |
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|
via actimetry (Actigraph GT9x, Pensacola, Florida, USA) |
| Inclusion, 3, 6 and 12 months |
| 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. | Inclusion, 3, 6 and 12 months |
| Measurement of physical capacity: walking distance (meters) | via the 6-minute walk test (6MWT). | Inclusion, 3, 6 and 12 months |
| Measurement of muscle strength: biceps muscle strength (kg) | via the handgrip (JAMAR Hand Dynamometer, Nottingham, UK). | Inclusion, 3, 6 and 12 months |
| 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 | Inclusion, 3, 6 and 12 months |
| 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. | Inclusion, 3, 6 and 12 months |
| 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. | Inclusion, 3, 6 and 12 months |
| Adoption of Acti-Pair program by physicians | Number of physicians including patients | through end of inclusion, an average of 30 months |
| Adoption of Acti-Pair program by peers | Number of peers recruited | through end of inclusion, an average of 30 months |
| Adoption of Acti-Pair program by Adapted Physical Activity (APA) professionals | Number of patients followed by APA professionals | 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 | Number of hours spend to follow-up patient specifically for the Acti-Pair program by peers, Adapted Physical Activity (APA) professionals and health professionals | through study completion, an average of 42 Months |
| 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 | Before and after the implementation of the intervention |
| Percentage of adherence to the intervention | via the number of patients continuing the programme 12 months after initiation | 12 months |
| 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). | Inclusion, 3, 6 and 12 months |
| 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. | 12 months |
| 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. | 12 months |
| 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 | 12 months |
| 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 | 12 months |
| CH Chambéry | Not yet recruiting | Chambéry | France |
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| Activité Physique Adaptée - DAHLIR 63 | Not yet recruiting | Clermont-Ferrand | France |
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| CHU Clermont-Ferrand - ONCOLOGIE | Not yet recruiting | Clermont-Ferrand | France |
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| CHU Clermont-Ferrand - Urologie | Not yet recruiting | Clermont-Ferrand | France |
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| Activité Physique Adaptée - CDOS Isère | Not yet recruiting | Grenoble | France |
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| CHU Grenoble - Urologie | Not yet recruiting | Grenoble | France |
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| Activité Physique Adaptée - DAHLIR 43 | Not yet recruiting | Le Puy-en-Velay | France |
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| CH Le Puy en Velay | Not yet recruiting | Le Puy-en-Velay | France |
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| HCL - Hôpital Edouard Herriot | Not yet recruiting | Lyon | 69000 | France |
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| HCL - Hôpital Croix Rousse | Not yet recruiting | Lyon | 69004 | France |
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| Activité Physique Adaptée - DAHLIR 69 | Not yet recruiting | Lyon | France |
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| CLB - Oncologie | Not yet recruiting | Lyon | France |
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| CLB - Radiothérapie | Not yet recruiting | Lyon | France |
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| HCL - CH Lyon Sud | Not yet recruiting | Lyon | France |
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| Activité Physique Adaptée - CDOS Ardèche | Not yet recruiting | Privas | France |
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| CH Roanne | Not yet recruiting | Roanne | France |
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| Activité Physique Adaptée - DAPAP 42 | Not yet recruiting | Saint-Etienne | France |
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| CHU Saint-Etienne - Oncologie | Recruiting | Saint-Etienne | France |
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| CHU Saint-Etienne - Radiothérapie | Not yet recruiting | Saint-Etienne | France |
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| Hôpital Privé de la Loire | Recruiting | Saint-Etienne | France |
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| Clinique du parc | Not yet recruiting | Saint-Priest-en-Jarez | 42270 | France |
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| Activité Physique Adaptée - CDOS Drôme | Not yet recruiting | Valence | France |
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| Hôpitaux Drôme Nord - Valence | Not yet recruiting | Valence | France |
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| Radiologie Drôme-Ardèche - Valence | Not yet recruiting | Valence | France |
|
| 25876555 | Background | 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. |
| 31720802 | Background | 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. |
| 23296635 | Background | 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. |
| 25877784 | Background | 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. |
| 19842459 | Background | 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. |
| 28829716 | Background | 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. |
| 25110844 | Background | 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. |
| 28685892 | Background | 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. |
| 35063040 | Background | 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. |
| 39717077 | Derived | 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. |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001519 | Behavior |
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