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

Prostate Cancer Clinical Trial

— ACTI-PAIR2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05739565
• Other study ID #: 20PH286
• Secondary ID: 2022-A01094-39
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: HUPIN DAVID, MD
• Phone: (0)477828413
• Email: David.Hupin[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 850
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Activité Physique Adaptée - CDOS Savoie	Chambéry
France	CH Chambéry	Chambéry
France	Activité Physique Adaptée - DAHLIR 63	Clermont-Ferrand
France	CHU Clermont-Ferrand - ONCOLOGIE	Clermont-Ferrand
France	CHU Clermont-Ferrand - Urologie	Clermont-Ferrand
France	Activité Physique Adaptée - CDOS Isère	Grenoble
France	CHU Grenoble - Urologie	Grenoble
France	Activité Physique Adaptée - DAHLIR 43	Le Puy-en-Velay
France	CH Le Puy en Velay	Le Puy-en-Velay
France	Activité Physique Adaptée - DAHLIR 69	Lyon
France	CLB - Oncologie	Lyon
France	CLB - Radiothérapie	Lyon
France	HCL - CH Lyon Sud	Lyon
France	HCL - Hôpital Croix Rousse	Lyon
France	HCL - Hôpital Edouard Herriot	Lyon
France	Activité Physique Adaptée - CDOS Ardèche	Privas
France	CH Roanne	Roanne
France	Activité Physique Adaptée - DAPAP 42	Saint-Étienne
France	CHU Saint-Etienne - Oncologie	Saint-Étienne
France	CHU Saint-Etienne - Radiothérapie	Saint-Étienne
France	Hôpital Privé de la Loire	Saint-Étienne
France	Clinique du parc	Saint-Priest-en-Jarez
France	Activité Physique Adaptée - CDOS Drôme	Valence
France	Hôpitaux Drôme Nord - Valence	Valence
France	Radiologie Drôme-Ardèche - Valence	Valence

Sponsors (6)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	INSERM ECEVE 1123, INSERM, CIC1408, INSERM, SAINBIOSE U1059, Ministry of Health, France, Sport Health Center of Auvergne-Rhône Alpes

Country where clinical trial is conducted

France, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View 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. — View 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. — View Citation

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. — View 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. — View 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. — View 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. — View Citation

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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Objective measure of physical inactivity (in h/d)	via actimetry (Actigraph GT9x, Pensacola, Florida, USA)	Inclusion, 3, 6 and 12 months
Secondary	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
Secondary	Measurement of physical capacity: walking distance (meters)	via the 6-minute walk test (6MWT).	Inclusion, 3, 6 and 12 months
Secondary	Measurement of muscle strength: biceps muscle strength (kg)	via the handgrip (JAMAR Hand Dynamometer, Nottingham, UK).	Inclusion, 3, 6 and 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Adoption of Acti-Pair program by physicians	Number of physicians including patients	through end of inclusion, an average of 30 months
Secondary	Adoption of Acti-Pair program by peers	Number of peers recruited	through end of inclusion, an average of 30 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage of adherence to the intervention	via the number of patients continuing the programme 12 months after initiation	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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