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Trial record 1 of 1 for:    NCT04354233
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A Physical Activity Program to Improve Quality of Life and Reduce Fatigue in Metastatic Breast Cancer (ABLE02)

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ClinicalTrials.gov Identifier: NCT04354233
Recruitment Status : Recruiting
First Posted : April 21, 2020
Last Update Posted : January 4, 2022
Sponsor:
Collaborators:
Fondation ARC
Janssen, LP
Information provided by (Responsible Party):
Centre Leon Berard

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.


Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Device: Physical activity intervention with connected devices Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care
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
Actual Study Start Date : June 24, 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Physical activity intervention with connected devices
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
Device: Physical activity intervention with connected devices
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.

No Intervention: Standard care
Women will receive stardard care and physical activity international recommendations, without further intervention



Primary Outcome Measures :
  1. time to deterioration of global health status (GHS) score of EORTC QLQ C30 [ Time Frame: Month 18 ]

    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.


  2. time to deterioration of fatigue score of EORTC QLQ C30 [ Time Frame: Month 18 ]

    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 :
  1. Overall survival [ Time Frame: Month 18 ]
    Period from the date of randomization to the date of event defined as death from any cause

  2. Progression free survival [ Time Frame: Month 18 ]
    Period from the date of randomization to the date of event defined as progression of the disease or death from any cause

  3. Other dimensions of health-related quality of life of the EORTC QLQ C30 [ Time Frame: Baseline, Month 3, Month 6, Month 12 ]

    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.


  4. Fatigue [ Time Frame: Baseline, Month 3, Month 6, Month 12 ]
    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.

  5. Proportion of patients who change their physical condition (6-min walking distance) [ Time Frame: Change between baseline, Month 3, Month 6 and Month 12 ]
    6-min walking distance

  6. Proportion of patients who change their physical condition (sit-to-stand) [ Time Frame: Change between baseline, Month 3, Month 6 and Month 12 ]
    Sit-to-stand

  7. Proportion of patients who change their physical condition (handgrip strength) [ Time Frame: Change between baseline, Month 3, Month 6 and Month 12 ]
    Handgrip strength

  8. Proportion of patients who change their weight [ Time Frame: Change between baseline, Month 3, Month 6 and Month 12 ]
    Body weight (kg)

  9. Proportion of patients who change their waist circumference [ Time Frame: Change between baseline, Month 3, Month 6 and Month 12 ]
    Waist circumference (cm)

  10. Proportion of patients who change their hip circumference [ Time Frame: Change between baseline, Month 3, Month 6 and Month 12 ]
    Hip circumference (cm)

  11. Proportion of patients who change their physical activity level [ Time Frame: Change between baseline, Month 3, Month 6 and Month 12 ]
    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).

  12. Proportion of patients who change sleep disorders [ Time Frame: Change between baseline and Month 6 ]

    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.


  13. Proportion of patients who loss muscle mass (sarcopenia) [ Time Frame: Change between baseline, Month 3, Month 6, Month 12 and at first progression up to Month 18 ]
    CT scans

  14. Proportion of patients who change their dietary patterns [ Time Frame: Change between baseline and Month 6 ]
    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.

  15. Proportion of patients who have severe toxicity (grade > 2) [ Time Frame: Month 12 ]
    Occurrence of severe toxicity (grade > 2) according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE)

  16. Proportion of patients who have modifications in inflammation and sarcopenia according to blood sample analysis [ Time Frame: Change between baseline, Month 3, Month 6, Month 12 and at first progression up to Month 18 ]

    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.


  17. Proportion of patients who have modifications on oxidative stress according to blood sample analysis [ Time Frame: Change between baseline, Month 3, Month 6, Month 12 and at first progression up to Month 18 ]

    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).


  18. Proportion of patients who modify their personnality factors [ Time Frame: Change between baseline and Month 6 ]
    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.

  19. Proportion of patients who modify their behaviour in association with physical activity [ Time Frame: Change between baseline and Month 6 ]
    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.

  20. Proportion of patients who accept the connected device (in the intervention arm only) [ Time Frame: Month 6 ]
    Acceptability questionnaire will be assessed by a 21-item questionnaire to evaluate satisfaction concerning the use of connected devices (application, website, quizz, activity tracker).

  21. Proportion of patients who are compliant to the PA intervention (in the intervention arm only) [ Time Frame: Month 6 ]
    Performed 3 PA sessions per week

  22. Proportion of patients who modify their cognition [ Time Frame: Change between baseline, Month 6 and Month 12 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04354233


Contacts
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Contact: Aurélia MAIRE, MSc 0469856362 aurelia.maire@lyon.unicancer.fr
Contact: Olivia PEROL, MSc 0478782897 olivia.perol@lyon.unicancer.fr

Locations
Show Show 18 study locations
Sponsors and Collaborators
Centre Leon Berard
Fondation ARC
Janssen, LP
Investigators
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Principal Investigator: Olivier TREDAN, MD, PhD Centre Leon Berard
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT04354233    
Other Study ID Numbers: ABLE02
ET20-022 ( Other Identifier: Sponsor ID )
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: January 4, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Leon Berard:
Metastatic breast cancer
Physical activity
Connected devices
e-Health
Quality of life
Fatigue
Additional relevant MeSH terms:
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Breast Neoplasms
Fatigue
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases