Impact of Personalized and Remote Support Centered on Exercise and Physical Activity for Breast Cancer Patients

For each summary score (PCS and MCS) separately, the success or failure score will be calculated :

• For patients with an intermediate or good QoL at baseline (summary score≥50), failure is defined as a score decrease ≥ 5 points whereas a stable measure (difference of less than 5 points) and improvement of ≥ 5 points will be classified as a success.
• For patients with a relatively poor QoL at baseline (summary score <50), success is defined as a score increase of 5 points or more at 12 months. All other cases are classified as a failure.

The HRQoL evaluated with the Short-Form-36 questionnaire. We chose the SF-36 generic questionnaire to assess HRQoL of these patients instead of a cancer-specific HRQoL questionnaire such as the EORTC QLQ-C30. In fact, the QLQ-C30 as well as majority of cancer-specific questionnaires is focused on symptoms and side effects such as nausea and vomiting, which are not relevant for cancer survivorship. Thus, patients will not concerned by these items. The creation of an EORTC cancer survivorship questionnaire is ongoing, but this questionnaire is not validated yet at the time of the start of this study. Thus, a generic questionnaire, the SF-36, was considered as more relevant and sensitive to change for these patients.

The EPA will be evaluated with the Global Physical Activity Questionnaire for the patient's subjective measure and with the connected watch in the experimental arm for the objective measure.

The Global Physical Activity Questionnaire is an instrument to assess physical activity. It was developed under the auspices of the WHO in 2002. GPAQ comprises 19 questions grouped to capture physical activity undertaken in different behavioral domains, these are work, transport and discretionary (also known as leisure or recreation). Within the work and discretionary domains, questions assess the frequency and duration of 2 differents categories of activity defined by the energy requirement or intensity. In the transport domain, the frequency and duration of all walking and cycling is captured but no attempt is made to differentiate between these activities. One additional item collected time spent in sedentary activities.

Will be evaluated with the Brief Fatigue Inventory auto-questionnaire The Brief Fatigue Inventory (BFI) is a questionnaire uses an 11-point scale (0 to 10) to measure the specific symptom of cancer-related fatigue in a single dimension. Nine items ask patients to rate the severity of their fatigue at its "worst," "usual," and "now" during the past 24 hours, with 0 = "no fatigue" and 10 = "fatigue". Cut points for fatigue severity are defined in two categories: a "fatigue worst" rating of 7 or greater indicates "severe" and 0 to 6 indicates "non-severe." Six additional items describe how much fatigue has interfered with different aspects of the patient's life during the past 24 hours. These items include general activity, mood, walking ability, normal work (includes both work outside the home and housework), relationships with other people, and enjoyment life.

Will be evaluated with the Brief Pain Inventory-SF (Brief Pain Inventory-short form) auto-questionnaire The Brief Pain Inventory - Short Form (BPI-sf) is used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. It is a 9 item self-administered questionnaire. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale.

Will be evaluated with the Hospital Anxiety and Depression Scale auto-questionnaire The Hospital Anxiety and Depression Scale (HADS) is a self-administrated questionnaire to detect anxiety and depressive disorders, validated in French with a general population and suffering from cancer. It has 14 items with 4 answers proposed and each correspond to a score between 0 to 3. Seven questions relate to anxiety and seven others to depressive dimension, thus allowing two scores to be obtained (maximum score of each score = 21). For subscales, a score of 0 to 7 is an absence of disorders (anxiety or depressive, depending on the subscale), 8 to 10 to a suspected disorder and 11 to 21 to a proven disorder.

Sleep will be evaluated in both arms using the Pittsburgh Sleep ≥Index (PSQI). In the experimental group, the number of hours of light and deep sleep will also be collected (connected watch).

The Pittsburgh Sleep Quality Index (PSQI) is designed to measure sleep quality over a onemonth interval. It includes 19 self-rated questions that generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Component scores (range 0 to 3) are summed to provide a global sleep quality score (range 0 to 21); a score greater than five indicates poor sleep quality.

Will be evaluated with the weight, BMI, fat mass, lean mass, waist size and hip size.

These multiple measurements will be aggregated to arrive at one reported value, for exemple BMI.

Will be evaluated through differents physical exercices, for exemple:

• Chair test (resistance test of lower limbs)
• Weight test (resistance test of upper limbs)
• Hand grip test (gripping force)
• Goniometer test (flexibility of upper limbs)
• Test of unipodal support (balance)
• 6-min walking test
• Heart rate by telemetry (Beating per minute - cardiac rhythm)
• Borg Rating of Perceived Exertion Scale And these multiple measurements will be aggregated to arrive at one reported value.

Adverse Events graded according to NCI-CTC-AE v5, considering all types of AE, related to the evaluated program or to concomitant/previous anti-cancer treatments

Professional activity status before diagnosis and after anti-cancer treatment (temporary interruption, partial time work…).

At baseline and during the follow-up, record the professional staut of the patients to provide the statistical trend regarding the professional activities.

Will be evaluated with the frequency of psychotropic (including hypnotic) and analgesic intake

Disease-free survival defined as the time between randomization and relapse or death from any cause.

Using EQ-5D and EQ VAS (study entry, M4, M8 and M12) and direct medical costs from inclusion up the M12.

The descriptive system comprises five dimensions. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The respondent is asked to indicate her health state by ticking in the box against the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for five dimensions can be combined in a 5-digit number describing the respondent's health state (for instance, " 11111 " corresponding to the perfect health).

The EQ VAS records the respondent's self-rated health on a 20 cm vertical (graduate 0 to 100), visual analogue scale with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'.