Breast Cancer
Conditions
Keywords
Breast cancer, physical activty, KHEOPS program
Brief summary
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
BEHAVIORALKHEOPS program
the KHEOPS program is an physical activity intervention, offered to patients
Sponsors
Centre Leon Berard
Cancéropôle Lyon Auvergne Rhône-Alpes
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| score for each construct of multiprocess action control model (M-PAC) | 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) | * The score for each M-PAC construct oriented toward participation in PA sessions throughout the KHEOPS program; * The score for each M-PAC construct oriented towards PA practice after the KHEOPS program program during the intervention. Constructs of M-PAC : * Attitude towards Physical Activity - Affective Attitude (7-point Likert Scale, extremely disagree to extremely agree) * Attitude towards Physical Activity - Instrumental Attitude (7-point Likert Scale, extremely disagree to extremely agree) * Perceived Capability over Physical Activity (5-point Likert Scale, strongly disagree to strongly agree) * Perceived Opportunity for Physical Activity (5-point Likert Scale, strongly disagree to strongly agree) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| acceptability | Post-intervention (week 22) | participation rate (\>70%) and dropout rate (\<20%) |
| completion rate of bi-weekly online questionnaires during the intervention | each monday (Monday week 1 to monday week 22), one friday per month (Friday week 1 to friday week 22) | (\>80%) |
| cancer-related psychological symptoms during and after the program | 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) | \- depressive symptoms, by Patient Health Questionnaire |
Countries
France
Contacts
CONTACTCarmen Dupuis, PhD
STUDY_DIRECTOROlivia Perol, PhD
Département Prévention Cancer Environnement, Centre Léon Bérard
PRINCIPAL_INVESTIGATORBéatrice Fervers, Pr
Département Prévention Cancer Environnement, Centre Léon Bérard
STUDY_DIRECTORJohan Caudroit, PhD
Université Lyon1
Outcome results
None listed