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NCT Number: NCT05739565

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

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.

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Key information

Conditions

Prostate Cancer Behavior Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Motor Activity Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Activité Physique Adaptée - CDOS Savoie, Chambéry, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  • 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 outcomes

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

    Time frame: Month: 12

    via actimetry (Actigraph GT9x, Pensacola, Florida, USA) 12 months (+/- 1 month) after the patient's inclusion in the Acti-Pair program

Secondary outcomes

  1. 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

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

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

    Time frame: Inclusion, 3, 6 and 12 months

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

  3. 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

    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.

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

    Time frame: Inclusion, 3, 6 and 12 months

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

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

    Time frame: Inclusion, 3, 6 and 12 months

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

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

    Time frame: Inclusion, 3, 6 and 12 months

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

  7. Level of fatigue

    Time frame: Inclusion, 3, 6 and 12 months

    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.

  8. Health-related quality of life

    Time frame: Inclusion, 3, 6 and 12 months

    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.

  9. Adoption of Acti-Pair program by physicians

    Time frame: through end of inclusion, an average of 30 months

    Number of physicians including patients

  10. Adoption of Acti-Pair program by peers

    Time frame: through end of inclusion, an average of 30 months

    Number of peers recruited

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

    Time frame: through study completion, an average of 42 Months

    Number of patients followed by APA professionals

  12. 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

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

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

    Time frame: Before and after the implementation of the intervention

    Semi-structured interviews

  14. Percentage of adherence to the intervention

    Time frame: 12 months

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

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

    Time frame: Inclusion, 3, 6 and 12 months

    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).

  16. Alliance between the patient and the peer

    Time frame: 12 months

    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.

  17. Patients, peers and professionals satisfaction

    Time frame: 12 months

    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.

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

    Time frame: 12 months

    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

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

    Time frame: 12 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Amandine BAUDOT, CRA

CONTACT

[email protected]

(0)477829450 ext. +33

HUPIN DAVID, MD

CONTACT

[email protected]

(0)477828413 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • INSERM ECEVE 1123
  • INSERM, SAINBIOSE U1059
  • Institut National de la Santé Et de la Recherche Médicale, France
  • Ministry of Health, France
  • Sport Health Center of Auvergne-Rhône Alpes

Registry information

Official study 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

Acronym: ACTI-PAIR2

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Feb 22, 2023
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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