INTRODUCTION: Patients with a metastatic breast cancer suffer from a deteriorated quality of life and numerous symptoms such as pain, severe fatigue and a decrease of their physical fitness. As the feasibility of a physical activity program has been demonstrated in this population, ABLE02 aims to assess the efficacy of a 6 month-physical activity program based on connected devices to improve health-related quality of life and to reduce fatigue in women with metastatic breast cancer. METHODS/ANALYSIS: ABLE02 is a prospective, multicenter, randomized, controlled and, open-label study. 244 patients with a metastatic breast cancer , at least one positive hormone receptor and a first-line chemotherapy planned will be randomly assigned (1:1 ratio) to: (i) the intervention arm to receive physical activity recommendations, an activity tracker to wear 24 hours a day during the whole intervention (6 months) with at least three walking sessions weekly and quizzes to answer each week on physical activity and nutrition (ii) the control arm to receive physical activity recommendations only. Assessments will be conducted at baseline, M3, M6, M12 and M18 to evaluate the clinical, physical, biological and psychological parameters and survival of participants. All questionnaires will be completed on a dedicated application. DISCUSSION: An activity program based on smartphone application linked to an activity tracker may help to improve quality of life and reduce fatigue of patients with a metastatic breast cancer. The growth of e-health offers the opportunity to get real-time data as well as improving patient empowerment in order to change long-term behaviors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
244
Participants randomized in the intervention arm will receive recommandations in physical activity. They will also receive an activity tracker Withings Steel to wear during 6 months. The tracker will be connected to the "Withings Health Mate" application and the ABLE02 application. Participants will be encouraged to practice at least three walking sessions weekly of more than 10 consecutive minutes. Concerning the number of steps per day, the first objective will be determined according to the 6-min walking distance and to participants' preferences and capacities. The objective will be recalculated monthly according to the number of steps performed the previous week and will be adapted by the physical activity (PA) instructor and participants. Phone calls with the participants are regularly planned. Weekly quizzes on PA and nutrition will be proposed through the ABLE02 application. A messaging system and a phone line will be available for participants to contact the study team.
CHU Amiens
Amiens, France
ACTIVE_NOT_RECRUITINGInstitut de Cancérologie de l'Ouest (ICO)
Angers, France
ENROLLING_BY_INVITATIONCHU Avignon
Avignon, France
RECRUITINGCH Fleyriat
Bourg-en-Bresse, France
RECRUITINGCH Cotentin
Cherbourg, France
ACTIVE_NOT_RECRUITINGCH Cholet
Cholet, France
RECRUITINGCGFL
Dijon, France
ENROLLING_BY_INVITATIONGroupement Hospitalier Mutualiste
Grenoble, France
RECRUITINGCentre Léon Bérard (CLB)
Lyon, France
RECRUITINGHospices Civils de Lyon
Lyon, France
ENROLLING_BY_INVITATION...and 8 more locations
time to deterioration of global health status (GHS) score of EORTC QLQ C30
Health-Related Quality of Life (HRQoL) and fatigue will be measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality Of Life Questionnaire (QLQ-C30). QLQ-C30 questionnaire consists of 30 items to evaluate 5 functioning domains (physical, role, emotional, cognitive, and social), a global HRQoL domain, 3 symptom domains (pain, fatigue and nausea) and 6 single items (dyspnea, insomnia, anorexia, diarrhea, constipation and financial impact). Participants will answer to a Likert scale ranging from "not at all" to "very much" and from "very bad" to "excellent" only for the global HRQoL questions. All scores will be standardized to a 0 to 100 scale according to the EORTC scoring manual. Higher scores represent better functioning, better global HRQoL and greater symptom burden. Deterioration is defined as a 5-point decrease relative to baseline in GHS score, with no subsequent increase above this threshold.
Time frame: Month 18
time to deterioration of fatigue score of EORTC QLQ C30
Health-Related Quality of Life (HRQoL) and fatigue will be measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality Of Life Questionnaire (QLQ-C30). QLQ-C30 questionnaire consists of 30 items to evaluate 5 functioning domains (physical, role, emotional, cognitive, and social), a global HRQoL domain, 3 symptom domains (pain, fatigue and nausea) and 6 single items (dyspnea, insomnia, anorexia, diarrhea, constipation and financial impact). Participants will answer to a Likert scale ranging from "not at all" to "very much" and from "very bad" to "excellent" only for the global HRQoL questions. All scores will be standardized to a 0 to 100 scale according to the EORTC scoring manual. Higher scores represent better functioning, better global HRQoL and greater symptom burden. A deterioration of fatigue is defined as a 5-point increase relative to baseline fatigue score, with no subsequent decrease above this threshold.
Time frame: Month 18
Overall survival
Period from the date of randomization to the date of event defined as death from any cause
Time frame: Month 18
Progression free survival
Period from the date of randomization to the date of event defined as progression of the disease or death from any cause
Time frame: Month 18
Other dimensions of health-related quality of life of the EORTC QLQ C30
Health-Related Quality of Life (HRQoL) and fatigue will be measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality Of Life Questionnaire (QLQ-C30). QLQ-C30 questionnaire consists of 30 items to evaluate 5 functioning domains (physical, role, emotional, cognitive, and social), a global HRQoL domain, 3 symptom domains (pain, fatigue and nausea) and 6 single items (dyspnea, insomnia, anorexia, diarrhea, constipation and financial impact). Participants will answer to a Likert scale ranging from "not at all" to "very much" and from "very bad" to "excellent" only for the global HRQoL questions. All scores will be standardized to a 0 to 100 scale according to the EORTC scoring manual. Higher scores represent better functioning, better global HRQoL and greater symptom burden. All of the secondary health-related quality of life dimensions except the global score and fatigue are evaluated.
Time frame: Baseline, Month 3, Month 6, Month 12
Fatigue
Multidimensional aspects of fatigue will be assessed by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-FA12 cancer related fatigue module. EORTC QLQ-FA12 consists of 12 items to evaluated physical, cognitive and emotional domains of cancer-related fatigue. Participants will answer to a 4-points Likert scale ranging from "not at all" to "very much". All scores will be transformed to a 0 to 100 scale and higher scores will indicate greater degree of fatigue.
Time frame: Baseline, Month 3, Month 6, Month 12
Proportion of patients who change their physical condition (6-min walking distance)
6-min walking distance
Time frame: Change between baseline, Month 3, Month 6 and Month 12
Proportion of patients who change their physical condition (sit-to-stand)
Sit-to-stand
Time frame: Change between baseline, Month 3, Month 6 and Month 12
Proportion of patients who change their physical condition (handgrip strength)
Handgrip strength
Time frame: Change between baseline, Month 3, Month 6 and Month 12
Proportion of patients who change their weight
Body weight (kg)
Time frame: Change between baseline, Month 3, Month 6 and Month 12
Proportion of patients who change their waist circumference
Waist circumference (cm)
Time frame: Change between baseline, Month 3, Month 6 and Month 12
Proportion of patients who change their hip circumference
Hip circumference (cm)
Time frame: Change between baseline, Month 3, Month 6 and Month 12
Proportion of patients who change their physical activity level
PA level will be measured by the Godin Leisure-Time Exercise Questionnaire (GSLTPAQ). The GSLTPAQ is a short validated self-administrated physical activity (PA) questionnaire which includes three main questions about frequency of low (e.g., easy walking), moderate (e.g., brisk walking), and strenuous (e.g., jogging) leisure-time PA of at least 15 minutes duration in a typical week. The total score is obtained by multiplying frequencies from mild, moderate and strenuous PA by three, five and nine metabolic equivalents respectively and adding these together. Finally this score is divided into three categories (≥ 24 units is equivalent to mild active; between 14 and 23 units is equivalent to moderately active and \< 14 units is equivalent to insufficiently active).
Time frame: Change between baseline, Month 3, Month 6 and Month 12
Proportion of patients who change sleep disorders
Perceived sleep quality will be measured with the Pittsburgh Sleep Quality Index (PSQI) evaluating seven sleep components: (1) sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbance, (6) use of sleeping medication, and (7) daytime dysfunction. Each of the seven components is rated on a Likert scale from "Not during last month" (0) to "3 or 4 times per week" (3). The total score resulting from the sum of the seven components ranges from 0 to 21, and a cut off 5 has been found to reflect clinically significant sleep disturbances. The quality of sleep will also be evaluated by the activity tracker based on automatic recognition of total duration of sleep, duration of deep and light sleep per night for the intervention arm only.
Time frame: Change between baseline and Month 6
Proportion of patients who loss muscle mass (sarcopenia)
CT scans
Time frame: Change between baseline, Month 3, Month 6, Month 12 and at first progression up to Month 18
Proportion of patients who change their dietary patterns
Dietary patterns will be assessed using a qualitative food frequency questionnaire composed of 35 items. Participants will answer the question "how frequently do you consume this product" on a Likert-type scale ranging from "never or almost" to "once per day or more" (stating quantity only for the range "once per day or more"). The questionnaire will characterize the consumption of fruits, vegetables, cereals, milk, dairy products, bread, meat, fish, poultry, eggs, starches, plant fat, desserts, sweetened products, non-alcoholic beverages, cold cuts, fried food, fast foods, preprepared meals, crackers, and snacking.
Time frame: Change between baseline and Month 6
Proportion of patients who have severe toxicity (grade > 2)
Occurrence of severe toxicity (grade \> 2) according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Time frame: Month 12
Proportion of patients who have modifications in inflammation and sarcopenia according to blood sample analysis
Two 10mL blood samples will be collected before each physical assessment and before starting chemotherapy and at 1st progression. The following assays will be performed on plasma for the assessment of inflammation and biomarker of sarcopenia: Myostatin, Activin, Cortisol, TNF-alpha, IFN-gamma, IL-1beta, IL-6, Follistatin, GDF5 (BMP14), IL-10, IL-15, NH3, Aminogram. The levels of lymphocytes, monocytes, neutrophils will be extracted from the data of the routine blood test.
Time frame: Change between baseline, Month 3, Month 6, Month 12 and at first progression up to Month 18
Proportion of patients who have modifications on oxidative stress according to blood sample analysis
Two 10mL blood samples will be collected before each physical assessment and before starting chemotherapy and at 1st progression. The following assays will be performed on plasma for the assessment of oxidative stress: Advanced oxidation protein products (AOPP), malondialdehyde (MDA), Superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPX), Xanthine oxidase (XO), and Myeloperoxidase (MPO).
Time frame: Change between baseline, Month 3, Month 6, Month 12 and at first progression up to Month 18
Proportion of patients who modify their personnality factors
Based on the Five-Factor Model, personality traits will be assessed by the French Big Five Inventory questionnaire (BFI-Fr). The BFI-Fr contains 45 self-descriptive statements that assess the 5 personality traits: neuroticism (which refers to a propensity to experience negative emotions, distress, and anxiety), extraversion (a propensity to be energetic, sociable, and experience positive emotions); openness to experience (the tendency to be curious, imaginative, and to entertain new ideas, values, and experiences); conscientiousness (reflecting self-disciplined, planful, and organized); and agreeableness (which refers to cooperativeness and altruism). Each item was rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). All items will be recoded in the direction of the trait label, and the mean will be taken across items for each personality trait.
Time frame: Change between baseline and Month 6
Proportion of patients who modify their behaviour in association with physical activity
The process of change will be evaluated by a validated scale constructs from the transtheoretical model. The process of change scale is a 22-item self-administrated questionnaire to measure eight process of change: self-reevaluation (item 4,8 and 12), reinforcement management (items 7,15 and 12), self-liberation (items 8, 16 and 22), dramatic relief (items 2 and 10), environmental reevaluation (items 3 and 11), counterconditioning (items 5, 13 and 19), helping relationships (items 6, 14 and 20) and consciousness raising (items 1, 9 and 17). Participants will answer to a Likert scale ranging from 1 (never) to 5 (very often). Items in each process of change will be added and then an average score will be calculated. When the average is ≥ 3, the process of change is activated.
Time frame: Change between baseline and Month 6
Proportion of patients who accept the connected device (in the intervention arm only)
Acceptability questionnaire will be assessed by a 21-item questionnaire to evaluate satisfaction concerning the use of connected devices (application, website, quizz, activity tracker).
Time frame: Month 6
Proportion of patients who are compliant to the PA intervention (in the intervention arm only)
Performed 3 PA sessions per week
Time frame: Month 6
Proportion of patients who modify their cognition
The cancer-related cognitive impairment will be measured by the Functional Assessment of Cancer Therapy-Cognition (FACT-Cog). The FACT-Cog is a validated self-administrated questionnaire in order to assess memory, attention, concentration, language, and thinking abilities. The questionnaire is composed of 37 items with four subscales: patients' perceived cognitive impairments, perceived cognitive abilities, deficits observed or commented on by others, and impact of cognitive changes on HRQoL. Participant will answer how often this situation occurred during the last 7 days on a Likert-type scale ranging from "never" to "several times a day". For both scales, higher scores indicated better perceived cognitive function.
Time frame: Change between baseline, Month 6 and Month 12
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