Evolution of Clinical and Motivational Constructs During the Physical Activity Program KHEOPS, Already Offered to Patients at the Centre Léon Bérard
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: KHEOPS program.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Behavioral KHEOPS program
the KHEOPS program is an physical activity intervention, offered to patients
Primary outcome measures
- score for each construct of multiprocess action control model (M-PAC) [Time frame: 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)]
Secondary outcome measures (12)
- acceptability [Time frame: Post-intervention (week 22)]
- completion rate of bi-weekly online questionnaires during the intervention [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 1 center
- Centre Léon Bérard — Lyon
Identifiers
NCT: NCT07515326 · CANDY (ET 24-127) · 2024-A01075-42