Back to resultsA Physical Activity Program to Improve Quality of Life and Reduce Fatigue in Metastatic Breast Cancer (ABLE02)
Primary Purpose
Metastatic Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physical activity intervention with connected devices
Sponsored by
About this trial
This is an interventional supportive care trial for Metastatic Breast Cancer focused on measuring Metastatic breast cancer, Physical activity, Connected devices, e-Health, Quality of life, Fatigue
Eligibility Criteria
Inclusion Criteria:
- 1) female,
- 2) ≥ 18 years old,
- 3) histologically confirmed metastatic breast cancer, with at least one positive hormone receptor (HR+) and HER2-,
- 4) first-line chemotherapy planned (or until 1 month after the chemotherapy has started) with intravenous (Paclitaxel or Doxorubicin or Cyclophosphamide or Carboplatin) or per os (Capecitabine or Vinorelbine) administration - NB : a patient who has previously received one or more lines of hormone therapy and who must start a 1st line of chemotherapy is eligible,
- 5) Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2,
- 6) life expectancy ≥ 3 months,
- 7) willing to be involved throughout the study,
- 8) ability to practice a adapted physical activity (APA) certified by a medical certificate issued by the referring oncologist or the clinical investigator,
- 9) using a compatible smartphone or Tablet PC to download the application ABLE02 and Withings Health Mate (from iOS 10 and android 6.0 and more recent),
- 10) Internet access,
- 11) valid health insurance affiliation,
- 12) able to read, write and understand French.
Exclusion Criteria:
- 1) presence of unstable bone metastases or unconsolidated pathological fractures,
- 2) presence of central nervous system involvement with neurological deficits that prevent from walking,
- 3) presence of a history or co-existence of other primary cancer (except of in situ cancer regardless of the site and/or basal cell skin cancer and/or non-mammary cancer in complete remission for more than 5 years),
- 4) severe undernutrition (HAS) (i.e. for women ≤ 70 years old: a weight loss of ≥ 15% in 6 months or ≥10% in 1 month and for women over 70 years old: a weight loss of ≥ 15% in 6 months or ≥10% in 1 month, and body mass index <18 kg/m²),
- 5) presenting a PA contraindication (e.g., uncontrolled hypertension, uncontrolled heart disease),
- 6) concurrent participation in another PA study,
- 7) unable to be followed for medical, social, family, geographical or psychological reasons throughout the study,
- 8) deprived of liberty by judicial or administrative decision,
- 9) pregnant.
Sites / Locations
- CHU Amiens
- Institut de Cancérologie de l'Ouest (ICO)
- CHU AvignonRecruiting
- CH FleyriatRecruiting
- CH Cotentin
- CH CholetRecruiting
- CGFL
- Groupement Hospitalier MutualisteRecruiting
- Centre Léon Bérard (CLB)Recruiting
- Hospices Civils de Lyon
- CH Morlaix
- AP-HP
- Institut CurieRecruiting
- Institut GodinotRecruiting
- Centre Eugène Marquis
- Institut de Cancérologie de l'Ouest (ICO)
- Institut de Cancérologie Lucien Neuwirth (ICLN)
- Institut Gustave Roussy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Physical activity intervention with connected devices
Standard care
Arm Description
Women randomized to the intervention arm will follow a 6-month physical activity intervention using a connected device that includes an activity tracker, a smartphone and a mobile application. Patients will also receive physical activity international recommendations
Women will receive stardard care and physical activity international recommendations, without further intervention
Outcomes
Primary Outcome Measures
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 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.
Secondary Outcome Measures
Overall survival
Period from the date of randomization to the date of event defined as death from any cause
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
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.
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.
Proportion of patients who change their physical condition (6-min walking distance)
6-min walking distance
Proportion of patients who change their physical condition (sit-to-stand)
Sit-to-stand
Proportion of patients who change their physical condition (handgrip strength)
Handgrip strength
Proportion of patients who change their weight
Body weight (kg)
Proportion of patients who change their waist circumference
Waist circumference (cm)
Proportion of patients who change their hip circumference
Hip circumference (cm)
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).
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.
Proportion of patients who loss muscle mass (sarcopenia)
CT scans
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.
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)
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.
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).
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.
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.
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).
Proportion of patients who are compliant to the PA intervention (in the intervention arm only)
Performed 3 PA sessions per week
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.
Full Information
NCT ID
NCT04354233
First Posted
April 14, 2020
Last Updated
August 29, 2023
Sponsor
Centre Leon Berard
Collaborators
Fondation ARC, Janssen, LP
1. Study Identification
Unique Protocol Identification Number
NCT04354233
Brief Title
A Physical Activity Program to Improve Quality of Life and Reduce Fatigue in Metastatic Breast Cancer
Acronym
ABLE02
Official Title
A National, Multicenter, Randomized Controlled Trial to Assess the Efficacy of a Physical Activity Program to Improve Quality of Life and Reduce Fatigue in Women With Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 24, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Leon Berard
Collaborators
Fondation ARC, Janssen, LP
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
Metastatic breast cancer, Physical activity, Connected devices, e-Health, Quality of life, Fatigue
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
At the first visit of the study, participants will be randomly assigned (1:1 ratio), with minimization based on the presence of visceral metastases (presence vs. absence of visceral metastases), the method of administration of chemotherapy (intravenous vs. per os) and the 6-minute walking distance (6MWD) (<455 versus ≥ 455m based on the median of the pilot ABLE study) to: (i) the intervention arm to receive PA recommendations and benefit from a 6-month APA program (ii) the control arm to receive PA recommendations only.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
244 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Physical activity intervention with connected devices
Arm Type
Experimental
Arm Description
Women randomized to the intervention arm will follow a 6-month physical activity intervention using a connected device that includes an activity tracker, a smartphone and a mobile application. Patients will also receive physical activity international recommendations
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Women will receive stardard care and physical activity international recommendations, without further intervention
Intervention Type
Device
Intervention Name(s)
Physical activity intervention with connected devices
Intervention Description
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.
Primary Outcome Measure Information:
Title
time to deterioration of global health status (GHS) score of EORTC QLQ C30
Description
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
Title
time to deterioration of fatigue score of EORTC QLQ C30
Description
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
Secondary Outcome Measure Information:
Title
Overall survival
Description
Period from the date of randomization to the date of event defined as death from any cause
Time Frame
Month 18
Title
Progression free survival
Description
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
Title
Other dimensions of health-related quality of life of the EORTC QLQ C30
Description
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
Title
Fatigue
Description
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
Title
Proportion of patients who change their physical condition (6-min walking distance)
Description
6-min walking distance
Time Frame
Change between baseline, Month 3, Month 6 and Month 12
Title
Proportion of patients who change their physical condition (sit-to-stand)
Description
Sit-to-stand
Time Frame
Change between baseline, Month 3, Month 6 and Month 12
Title
Proportion of patients who change their physical condition (handgrip strength)
Description
Handgrip strength
Time Frame
Change between baseline, Month 3, Month 6 and Month 12
Title
Proportion of patients who change their weight
Description
Body weight (kg)
Time Frame
Change between baseline, Month 3, Month 6 and Month 12
Title
Proportion of patients who change their waist circumference
Description
Waist circumference (cm)
Time Frame
Change between baseline, Month 3, Month 6 and Month 12
Title
Proportion of patients who change their hip circumference
Description
Hip circumference (cm)
Time Frame
Change between baseline, Month 3, Month 6 and Month 12
Title
Proportion of patients who change their physical activity level
Description
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
Title
Proportion of patients who change sleep disorders
Description
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
Title
Proportion of patients who loss muscle mass (sarcopenia)
Description
CT scans
Time Frame
Change between baseline, Month 3, Month 6, Month 12 and at first progression up to Month 18
Title
Proportion of patients who change their dietary patterns
Description
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
Title
Proportion of patients who have severe toxicity (grade > 2)
Description
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
Title
Proportion of patients who have modifications in inflammation and sarcopenia according to blood sample analysis
Description
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
Title
Proportion of patients who have modifications on oxidative stress according to blood sample analysis
Description
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
Title
Proportion of patients who modify their personnality factors
Description
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
Title
Proportion of patients who modify their behaviour in association with physical activity
Description
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
Title
Proportion of patients who accept the connected device (in the intervention arm only)
Description
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
Title
Proportion of patients who are compliant to the PA intervention (in the intervention arm only)
Description
Performed 3 PA sessions per week
Time Frame
Month 6
Title
Proportion of patients who modify their cognition
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1) female,
2) ≥ 18 years old,
3) histologically confirmed metastatic breast cancer, with at least one positive hormone receptor (HR+) and HER2-,
4) first-line chemotherapy planned (or until 1 month after the chemotherapy has started) with intravenous (Paclitaxel or Doxorubicin or Cyclophosphamide or Carboplatin) or per os (Capecitabine or Vinorelbine) administration - NB : a patient who has previously received one or more lines of hormone therapy and who must start a 1st line of chemotherapy is eligible,
5) Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2,
6) life expectancy ≥ 3 months,
7) willing to be involved throughout the study,
8) ability to practice a adapted physical activity (APA) certified by a medical certificate issued by the referring oncologist or the clinical investigator,
9) using a compatible smartphone or Tablet PC to download the application ABLE02 and Withings Health Mate (from iOS 10 and android 6.0 and more recent),
10) Internet access,
11) valid health insurance affiliation,
12) able to read, write and understand French.
Exclusion Criteria:
1) presence of unstable bone metastases or unconsolidated pathological fractures,
2) presence of central nervous system involvement with neurological deficits that prevent from walking,
3) presence of a history or co-existence of other primary cancer (except of in situ cancer regardless of the site and/or basal cell skin cancer and/or non-mammary cancer in complete remission for more than 5 years),
4) severe undernutrition (HAS) (i.e. for women ≤ 70 years old: a weight loss of ≥ 15% in 6 months or ≥10% in 1 month and for women over 70 years old: a weight loss of ≥ 15% in 6 months or ≥10% in 1 month, and body mass index <18 kg/m²),
5) presenting a PA contraindication (e.g., uncontrolled hypertension, uncontrolled heart disease),
6) concurrent participation in another PA study,
7) unable to be followed for medical, social, family, geographical or psychological reasons throughout the study,
8) deprived of liberty by judicial or administrative decision,
9) pregnant.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurélia MAIRE, MSc
Phone
0469856362
Email
aurelia.maire@lyon.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Olivia PEROL, MSc
Phone
0478782897
Email
olivia.perol@lyon.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier TREDAN, MD, PhD
Organizational Affiliation
Centre Leon Berard
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Institut de Cancérologie de l'Ouest (ICO)
City
Angers
Country
France
Individual Site Status
Enrolling by invitation
Facility Name
CHU Avignon
City
Avignon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe DEBOURDEAU
First Name & Middle Initial & Last Name & Degree
Philippe DEBOURDEAU, MD, PhD
First Name & Middle Initial & Last Name & Degree
Antoine ARNAUD, MD, PhD
First Name & Middle Initial & Last Name & Degree
Bertrand BILLEMONT, MD, PhD
First Name & Middle Initial & Last Name & Degree
Rania BOUSTANY-GRENIER, MD, PhD
First Name & Middle Initial & Last Name & Degree
Gaëtan DE RAUGLAUDRE, MD, PhD
First Name & Middle Initial & Last Name & Degree
Julien GRENIER, MD, PhD
First Name & Middle Initial & Last Name & Degree
Sylvie KIRSCHER, MD, PhD
First Name & Middle Initial & Last Name & Degree
Alice MEGE, MD, PhD
First Name & Middle Initial & Last Name & Degree
Alma STANCU, MD, PhD
Facility Name
CH Fleyriat
City
Bourg-en-Bresse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hubert ORFEUVRE
First Name & Middle Initial & Last Name & Degree
Hubert ORFEUVRE, MD, PhD
First Name & Middle Initial & Last Name & Degree
Patrick ARNAUD-COFFIN, MD, PhD
First Name & Middle Initial & Last Name & Degree
Géraldine RAICHON-PATRU, MD, PhD
Facility Name
CH Cotentin
City
Cherbourg
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CH Cholet
City
Cholet
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margot NOBLECOURT
First Name & Middle Initial & Last Name & Degree
Margot NOBLECOURT, MD, PhD
First Name & Middle Initial & Last Name & Degree
Victor SIMMET, MD, PhD
Facility Name
CGFL
City
Dijon
Country
France
Individual Site Status
Enrolling by invitation
Facility Name
Groupement Hospitalier Mutualiste
City
Grenoble
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elise BONNET
First Name & Middle Initial & Last Name & Degree
Elise BONNET, MD, PhD
First Name & Middle Initial & Last Name & Degree
Claire GARNIER TIXIDRE, MD, PhD
First Name & Middle Initial & Last Name & Degree
Laurence LANCRY-LECOMTE, MD, PhD
First Name & Middle Initial & Last Name & Degree
Cécile LEYRONNAS, MD, PhD
Facility Name
Centre Léon Bérard (CLB)
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurélia MAIRE, MSc
Phone
0469856362
Email
aurelia.maire@lyon.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Olivia PEROL, MSc
Phone
0478782897
Email
olivia.perol@lyon.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Olivier TREDAN, MD, PhD
First Name & Middle Initial & Last Name & Degree
Thomas BACHELOT, MD, PhD
First Name & Middle Initial & Last Name & Degree
Pierre-Etienne HEUDEL, MD, PhD
First Name & Middle Initial & Last Name & Degree
Isabelle RAY-COQUARD, MD, PhD
First Name & Middle Initial & Last Name & Degree
Pauline ROCHEFORT, MD, PhD
First Name & Middle Initial & Last Name & Degree
Léa ROSSI, MD, PhD
First Name & Middle Initial & Last Name & Degree
Philippe TOUSSAINT, MD, PhD
First Name & Middle Initial & Last Name & Degree
Armelle DUFRESNE, MD, PhD
First Name & Middle Initial & Last Name & Degree
Mélodie CARBONNAUX, MD, PhD
Facility Name
Hospices Civils de Lyon
City
Lyon
Country
France
Individual Site Status
Enrolling by invitation
Facility Name
CH Morlaix
City
Morlaix
Country
France
Individual Site Status
Terminated
Facility Name
AP-HP
City
Paris
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Institut Curie
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence COUSSY
First Name & Middle Initial & Last Name & Degree
Florence COUSSY, MD, PhD
First Name & Middle Initial & Last Name & Degree
Audrey BELLESOEUR, MD, PhD
First Name & Middle Initial & Last Name & Degree
Edith BORCOMAN, MD, PhD
First Name & Middle Initial & Last Name & Degree
Paul COTTU, MD, PhD
First Name & Middle Initial & Last Name & Degree
Sophie FRANK, MD, PhD
First Name & Middle Initial & Last Name & Degree
Delphine LOIRAT, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jean-Yves PIERGA, MD, PhD
First Name & Middle Initial & Last Name & Degree
Emanuela ROMANO, MD, PhD
First Name & Middle Initial & Last Name & Degree
Marie-Paule SABLIN, MD, PhD
First Name & Middle Initial & Last Name & Degree
Pauline VAFLARD, MD, PhD
First Name & Middle Initial & Last Name & Degree
Carole BOULEUC, MD, PhD
Facility Name
Institut Godinot
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christelle JOUANNAUD
First Name & Middle Initial & Last Name & Degree
Christelle JOUANNAUD, MD, PhD
First Name & Middle Initial & Last Name & Degree
Damien BOTSEN, MD, PhD
First Name & Middle Initial & Last Name & Degree
Camille MAZZA, MD, PhD
First Name & Middle Initial & Last Name & Degree
Aude-Marie SAVOYE, MD, PhD
Facility Name
Centre Eugène Marquis
City
Rennes
Country
France
Individual Site Status
Enrolling by invitation
Facility Name
Institut de Cancérologie de l'Ouest (ICO)
City
Saint-Herblain
Country
France
Individual Site Status
Enrolling by invitation
Facility Name
Institut de Cancérologie Lucien Neuwirth (ICLN)
City
Saint-Étienne
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Institut Gustave Roussy
City
Villejuif
Country
France
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32620149
Citation
Delrieu L, Anota A, Tredan O, Freyssenet D, Maire A, Canada B, Fournier B, Febvey-Combes O, Pilleul F, Bouhamama A, Caux C, Joly F, Fervers B, Pialoux V, Perol D, Perol O. Design and methods of a national, multicenter, randomized and controlled trial to assess the efficacy of a physical activity program to improve health-related quality of life and reduce fatigue in women with metastatic breast cancer: ABLE02 trial. BMC Cancer. 2020 Jul 3;20(1):622. doi: 10.1186/s12885-020-07093-9.
Results Reference
derived
Learn more about this trial
A Physical Activity Program to Improve Quality of Life and Reduce Fatigue in Metastatic Breast Cancer
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