Evolution of Clinical and Motivational Constructs During the Physical Activity Program KHEOPS, Already Offered to Patients at the Centre Léon Bérard

Официальное название

Evolution of Psychological Determinants of Physical Activity and Cancer-related Psychological Symptoms in Patients Undergoing Treatment for Breast Cancer and Following a Physical Activity Program

Обзор

CANDY is a single-center, prospective study designed to observe the evolution of clinical and motivational constructs during the APA program KHEOPS program, already offered to patients at the Centre Léon Bérard (CLB). The main aim of the CANDY study is to observe the evolution of psychological constructs derived from M-PAC during a 13-week KHEOPS APA program in women undergoing treatment for breast cancer. Secondary objectives are: * to examine the feasibility of psychological measures and participation in the KHEOPS program * to observe cancer-related psychological symptoms during the KHEOPS program and to investigate the links between the temporal evolution of psychological factors (clinical and motivational) and adherence to the KHEOPS program, as well as the level of post-program PA during and after the KHEOPS program in patients followed at the CLB.

Вмешательства

• Поведенческое KHEOPS program
  the KHEOPS program is an physical activity intervention, offered to patients

Первичные конечные точки

• score for each construct of multiprocess action control model (M-PAC) [Срок оценки: Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), one friday per month (Friday week 1 to Friday week 22), post-intervention + 1 month (Week 26)]

Вторичные конечные точки (12)

• acceptability [Срок оценки: Post-intervention (week 22)]
• completion rate of bi-weekly online questionnaires during the intervention [Срок оценки: each monday (Monday week 1 to monday week 22), one friday per month (Friday week 1 to friday week 22)]
• cancer-related psychological symptoms during and after the program [Срок оценки: Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)]
• cancer-related psychological symptoms during and after the program [Срок оценки: Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)]
• cancer-related psychological symptoms during and after the program [Срок оценки: Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)]
• cancer-related psychological symptoms during and after the program [Срок оценки: Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)]
• cancer-related psychological symptoms during and after the program [Срок оценки: Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)]
• cancer-related psychological symptoms during and after the program [Срок оценки: Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)]
• cancer-related psychological symptoms during and after the program [Срок оценки: Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)]
• cancer-related psychological symptoms during and after the program [Срок оценки: Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)]
• cancer-related psychological symptoms during and after the program [Срок оценки: Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)]
• cancer-related psychological symptoms during and after the program [Срок оценки: Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26)]

Критерии участия

Критерии включения

• Woman aged ≥ 18 years
• Diagnosed with non-metastatic breast cancer
• Undergoing treatment or after surgery
• Participating in the CLB KHEOPS program, either face-to-face or distance learning
• Have a smartphone, computer or tablet to answer the 2 weekly online weekly online questionnaires and to follow APA sessions for patients following the patients following the KHEOPS program remotely
• Having received a study information note and having made a declaration of non-opposition
• Affiliated with a social security scheme
• Able to read, write and understand French

Критерии исключения

• Unable to be followed for medical, social, family, geographical or psychological reasons, for the duration of the study.
• Have difficulty completing a questionnaire alone
• Deprived of liberty by judicial or administrative decision, or adults protected by law
• Concurrently participating in another PA study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Франция · 1 центр

• Centre Léon Bérard — Lyon

Идентификаторы

NCT: NCT07515326 · CANDY (ET 24-127) · 2024-A01075-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗