About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients with breast cancer, with a current treatment, followed at CLB
Trial design
Case-only
Prospective
Treatments tested in this trial
KHEOPS program
Behavioralthe KHEOPS program is an physical activity intervention, offered to patients
Treatment groups
Trial outcomes
Primary outcomes
score for each construct of multiprocess action control model (M-PAC)
* 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 outcomes
acceptability
participation rate (\>70%) and dropout rate (\<20%)
completion rate of bi-weekly online questionnaires during the intervention
(\>80%)
cancer-related psychological symptoms during and after the program
\- depressive symptoms, by Patient Health Questionnaire
cancer-related psychological symptoms during and after the program
\- anxiety symptoms, by Generalized Anxiety Disorder
Sponsors and contacts
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Centre Leon Berard
Lead sponsor
Cancéropôle Lyon Auvergne Rhône-Alpes
Collaborator