Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Anti-Infective Agents

All Drugs and Chemicals

Metronidazole

This arm consists of providing patients with a personalized coaching focused on exercise and physical activity, with or without connected watch.

The standard supportive approach will consist in recommendations made during visits with the oncologist. The delivery of post-treatment care by oncologists and their team systematically provide exercise advice patients including recommendations for strength training and aerobic activity.

Patients will receive personalized physical activity coaching with an online digital platform to take online educational workshops and interact with other peers of the cohort with a online private forum. They will also have a connected watch that will measure several physical activity metrics.

Personalized Coaching (Arm A)

Patients will receive the standard recommendations during their visits with the oncologist. The exercise recommendations include strength training and aerobic activities.

Standard supportive approach (Arm B)

Laurence VANLEMMENS, MD

A study that evaluates the benefits of a personalized remote exercise and physical activity coaching compared with the standard supportive approach in terms of health-related quality of life at 12 months in breast cancer survivors treated in an adjuvant setting.

A multicentric, phase III, randomized open-labelled study with two parallel groups which evaluates the benefits of a personalized remote exercise and physical activity coaching compared with the standard supportive approach in terms of health-related quality of life at 12 months in breast cancer survivors treated in an adjuvant setting.

Other objectives include:

* To evaluate the impact of the intervention on each dimension of the SF-36 at 12 months
* To evaluate the impact of the program on the health-related quality of life over time
* To evaluate the impact of the program on the practice of exercise and physical activity (EPA) at the recommended intensity (30min of moderate EPA, 5 days/week)
* To evaluate the impact of the program on:

  o fatigue, pain, depression, sleep, motivation for the practice, self-respect, biometric measures (including fat mass and lean mass), physical capacities, patient's satisfaction regarding the assigned program, occurrence of Adverse Events (AE) related to the treatment, professional life for patients who worked before the announcement of getting cancer and psychotropic and analgesic drug intake
* To evaluate the compliance to the program through the engagement score during the first 4 months (in the experimental group).
* To evaluate the impact of the program in terms of disease-free survival

Additional objectives on health economics include:

* To evaluate the efficiency of the personalized remote exercise and physical activity coaching compared with the standard supportive approach in BC survivors treated in an adjuvant setting.
* To characterize the health-state utility of BC survivors over time; assessing the association of change in health-utility with changes in other variables such as exercise and physical activity.

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

Randomized Study Estimating the Impact of a Personalized and Remote Support Centered on Exercise and Physical Activity for Patients After Breast Cancer

This study will evaluate, in each randomized group, the difference between the baseline score and the 12-month score of summary score of this questionnaire: PCS (Physical Component Summary)

This study will evaluate, in each randomized group, the difference between the baseline score and the 12-month score of summary score of this questionnaire: MCS (Mental Component Summary)

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'.

Stimulab

Centre Oscar Lambret

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Mouth and Tooth Diseases

Rare Diseases

Prostatic Neoplasms

Lung Neoplasms

Uterine Cervical Neoplasms

Mouth Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Oral Cancer

Lip and Oral Cavity Cancer

The participant will self motivate hi/herself to increase physical activities.

The participant will receive personalized smart text messages to encourage him/her to increase physical activities

The participant will interact with intelligent coach on Amazon Alexa (a digital voice assist) to help him/her become more active

Personalized text messages to you cellphone to help you become more active

Mycoach Smart Text

This is an intelligent voice that you can communicate with via Amazon echo speaker

MyCoach on Amazon Alexa

Ahmed Hassoon, MD,MPH,PMP

PATH is a research study for cancer survivors to help participants to become more active. Studies suggested an association between inactivity and cancer. The investigators created new novel ways and technologies that may help participants to become more active. The three methods the investigators are studying are: 1) participant become active on her/his own; educational material will be provided; 2) working with a programmed health coach over the phone via text messages; and 3) using digital voice assist to help participant become more active. The digital voice assist will be delivered via Amazon Alexa on Echo speaker (it is the famous intelligent voice that you see in superball commercial by Alec Baldwin). This study is funded by the State of Maryland.

If the participant agree to be in this study, the investigators will ask the participant to do the following things:

The participant will be asked questions about his/her physical activity (walking, running or other exercise) to determine if he/she are eligible to participate. If the participant is eligible and interested in participating, the investigators will ask hi/her to read and sign the consent form.

After that, the investigators will randomly assign the participant to a research group (this method would be similar to drawing numbers from a hat). The result will determine which group the participant will belong to. The study would have three different groups:

1. Group one will be self-motivated to be physically active (control group)
2. The second group will receive smart daily text messages only (text group);
3. The last group would have the Amazon Echo smart device installed in participants' homes and they will interact with a digital voice assist that will help them be active (Alexa group).

   * All study participants will receive a Fitbit device which you can keep after the study.
   * When the investigators start the study, the participant will be asked to start wearing wrist device immediately. For the next one week the investigators will monitor the participant daily number of steps to establish how active he/she is. The participant will not be required to change his/her daily routine in the first week.
   * After the end of the first week, the investigators will ask the participant to increase his/her daily steps to at least 10 thousand steps per day for the next four weeks. In total the participant will have one week of hi/her normal daily routine and four weeks of trying to do 10 thousand steps per day or more.
   * If the participant is in the control group, the investigators will ask you to try to do 10 thousand steps per day on his/her own.
   * If the participant are in the text group, he/she will get smart text messages with healthy tips to help track his/her activities and reach his/her daily goal.
   * If the participant is in Alexa group, a study member will visit the participant at his/her home before the end of the first week to install the Echo smart speaker and to explain to the participant how to use the voice assist to help him/her become more active for the next four weeks.

This is a single center three arms randomized trial.

Physical Activities by Technology Help (PATH)

Novel Individualized Intervention for Behavioral Change Among High-Risk Group Cancer Survivors : Physical Activities by Technology Help (PATH)

The investigators will measure your physical activity by number of steps before and after intervention via wearable activity tracker.

Defined as 3 min. or more of uninterrupted activity measured by wearable sensor.

Time spent walking vs time spent sitting measured by all in one sensor.

Distribution parameter of number of steps per/minute within 24 hours period. Measured by all in one sensor.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Impact of Personalized and Remote Support Centered on Exercise and Physical Activity for Breast Cancer Patients	NCT04536584	Breast Cancer F...	Personalized Co... Standard suppor...	18 Years -	Centre Oscar Lambret
Physical Activities by Technology Help (PATH)	NCT03212079	Breast Cancer Prostate Cancer Lung Cancer Colorectal Canc... Cervical Cancer Oral Cancer	Mycoach Smart T... MyCoach on Amaz...	18 Years - 80 Years	Johns Hopkins University

Spots Global Cancer Trial Database for physical activities