scholarly journals A Personalized Physical Activity Program With Activity Trackers and a Mobile Phone App for Patients With Metastatic Breast Cancer: Protocol for a Single-Arm Feasibility Trial

10.2196/10487 ◽  
2018 ◽  
Vol 7 (8) ◽  
pp. e10487 ◽  
Author(s):  
Lidia Delrieu ◽  
Olivia Pérol ◽  
Béatrice Fervers ◽  
Christine Friedenreich ◽  
Jeff Vallance ◽  
...  
2018 ◽  
Author(s):  
Lidia Delrieu ◽  
Olivia Pérol ◽  
Béatrice Fervers ◽  
Christine Friedenreich ◽  
Jeff Vallance ◽  
...  

BACKGROUND About 5% of breast cancer cases are metastatic at diagnosis, and 20%-30% of localized breast cancer cases become secondarily metastatic. Patients frequently report many detrimental symptoms related to metastasis and treatments. The physical, biological, psychological, and clinical benefits of physical activity during treatment in patients with localized breast cancer have been demonstrated; however, limited literature exists regarding physical activity and physical activity behavior change in patients with metastatic breast cancer. OBJECTIVE The primary objective of this study is to assess the feasibility of a 6-month physical activity intervention with activity trackers in patients with metastatic breast cancer (the Advanced stage Breast cancer and Lifestyle Exercise, ABLE Trial). Secondary objectives are to examine the effects of physical activity on physical, psychological, anthropometrics, clinical, and biological parameters. METHODS We plan to conduct a single-center, single-arm trial with 60 patients who are newly diagnosed with metastatic breast cancer. Patients will receive an unsupervised and personalized 6-month physical activity program that includes an activity tracker Nokia Go and is based on the physical activity recommendation. Patients will be encouraged to accumulate at least 150 minutes per week of moderate-to-vigorous intensity physical activity. Baseline and 6-month assessments will include anthropometric measures, functional tests (eg, 6-minute walk test and upper and lower limb strength), blood draws, patient-reported surveys (eg, quality of life and fatigue), and clinical markers of tumor progression (eg, Response Evaluation Criteria In Solid Tumors criteria). RESULTS Data collection occurred between October 2016 and January 2018, and the results are expected in August 2018. CONCLUSIONS The ABLE Trial will be the first study to assess the feasibility and effectiveness of an unsupervised and personalized physical activity intervention performed under real-life conditions with activity trackers in patients with metastatic breast cancer. CLINICALTRIAL ClinicalTrials.gov NCT03148886; https://clinicaltrials.gov/ct2/show/NCT03148886 (Accessed by WebCite at http://www.webcitation.org/71yabi0la) REGISTERED REPORT IDENTIFIER RR1-10.2196/10487


2018 ◽  
Author(s):  
Lidia Delrieu ◽  
Vincent Pialoux ◽  
Olivia Pérol ◽  
Magali Morelle ◽  
Agnès Martin ◽  
...  

BACKGROUND There is limited knowledge regarding the potential benefits of physical activity in patients with metastatic breast cancer. OBJECTIVE The Advanced stage Breast cancer and Lifestyle Exercise (ABLE) Trial aimed to assess the feasibility of a physical activity intervention in women with metastatic breast cancer and to explore the effects of physical activity on functional, psychological, and clinical parameters. METHODS The ABLE Trial was a single-arm, 6-month intervention study with a home-based, unsupervised, and personalized walking program using an activity tracker. At baseline and 6 months, we assessed anthropometrics, functional fitness, physical activity level, sedentary behavior, quality of life, fatigue, and tumor progression. Paired proportions were compared using the McNemar test and changes of parameters during the intervention were analyzed using the Wilcoxon signed-rank test, the Mann-Whitney test, and Spearman rank correlations. RESULTS Overall, 49 participants (mean age 55 years; recruitment rate 94%) were enrolled and 96% adhered to the exercise prescription (attrition rate 2%). Statistically significant improvements in the 6-minute walking distance test (+7%, <i>P</i>&lt;.001) and isometric quadriceps strength (+22%, <i>P</i>&lt;.001), as well as decreases in body mass index (-2.5%, <i>P</i>=.03) and hip circumference (-4.0%, <i>P</i>&lt;.001) were observed at 6 months. Quality of life remained stable and a nonstatistically significant decrease (-16%, <i>P</i>=.07) in fatigue was observed. CONCLUSIONS The high recruitment and adherence rates suggest the willingness of patients with metastatic breast cancer to participate in a physical activity program. The beneficial outcomes regarding physical fitness and anthropometry of this unsupervised physical activity program may encourage these patients to maintain a physically active lifestyle. Future randomized controlled trials with larger sample sizes are warranted. CLINICALTRIAL ClinicalTrials.gov NCT03148886; https://clinicaltrials.gov/ct2/show/NCT03148886 INTERNATIONAL REGISTERED REPORT RR2-10.2196/10487


10.2196/12306 ◽  
2020 ◽  
Vol 8 (1) ◽  
pp. e12306
Author(s):  
Lidia Delrieu ◽  
Vincent Pialoux ◽  
Olivia Pérol ◽  
Magali Morelle ◽  
Agnès Martin ◽  
...  

Background There is limited knowledge regarding the potential benefits of physical activity in patients with metastatic breast cancer. Objective The Advanced stage Breast cancer and Lifestyle Exercise (ABLE) Trial aimed to assess the feasibility of a physical activity intervention in women with metastatic breast cancer and to explore the effects of physical activity on functional, psychological, and clinical parameters. Methods The ABLE Trial was a single-arm, 6-month intervention study with a home-based, unsupervised, and personalized walking program using an activity tracker. At baseline and 6 months, we assessed anthropometrics, functional fitness, physical activity level, sedentary behavior, quality of life, fatigue, and tumor progression. Paired proportions were compared using the McNemar test and changes of parameters during the intervention were analyzed using the Wilcoxon signed-rank test, the Mann-Whitney test, and Spearman rank correlations. Results Overall, 49 participants (mean age 55 years; recruitment rate 94%) were enrolled and 96% adhered to the exercise prescription (attrition rate 2%). Statistically significant improvements in the 6-minute walking distance test (+7%, P<.001) and isometric quadriceps strength (+22%, P<.001), as well as decreases in body mass index (-2.5%, P=.03) and hip circumference (-4.0%, P<.001) were observed at 6 months. Quality of life remained stable and a nonstatistically significant decrease (-16%, P=.07) in fatigue was observed. Conclusions The high recruitment and adherence rates suggest the willingness of patients with metastatic breast cancer to participate in a physical activity program. The beneficial outcomes regarding physical fitness and anthropometry of this unsupervised physical activity program may encourage these patients to maintain a physically active lifestyle. Future randomized controlled trials with larger sample sizes are warranted. Trial Registration ClinicalTrials.gov NCT03148886; https://clinicaltrials.gov/ct2/show/NCT03148886


Author(s):  
Lidia Delrieu ◽  
Agnès Martin ◽  
Marina Touillaud ◽  
Olivia Pérol ◽  
Magali Morelle ◽  
...  

Abstract Purpose Sarcopenia has been identified as an important prognostic factor for patients with cancer. This study aimed at exploring the potential associations between a 6-month physical activity intervention and muscle characteristics, sarcopenia, oxidative stress and toxicities in patients with metastatic breast cancer. Methods Women newly diagnosed with metastatic breast cancer (N = 49) participated in an unsupervised, personalized, 6-month physical activity intervention with activity tracker. Computerized tomography images at the third lumbar vertebra were analysed at baseline, three months and six months to assess sarcopenia (muscle mass index < 40 cm2/m2) and muscle quality (poor if muscle attenuation < 37.8 Hounsfield Units). Oxidative markers included plasma antioxidant enzymes (catalase, glutathione peroxidase and superoxide dismutase activities), prooxidant enzymes (NADPH oxidase and myeloperoxidase activities) and oxidative stress damage markers (advanced oxidation protein products, malondialdehyde (MDA) and DNA oxidation. Results At baseline 53% (mean age 55 years (SD 10.41)) were sarcopenic and 75% had poor muscle quality. Muscle cross sectional area, skeletal muscle radiodensity, lean body mass remained constant over the six months (p = 0.75, p = 0.07 and p = 0.75 respectively), but differed significantly between sarcopenic and non-sarcopenic patients at baseline and 6-months. Sarcopenic patients at baseline were more likely to have an increase of MDA (p = 0.02) at 6 months. Being sarcopenic during at least one moment during the 6-month study was associated with a higher risk of developing severe toxicities (grade > 2) (p = 0.02). Conclusions This study suggests potential benefits of physical activity for maintenance of muscle mass. Sarcopenia can alter many parameters and disturb the pro and antioxidant balance.


2013 ◽  
Author(s):  
Arianna Aldridge-Gerry ◽  
Oxana G. Palesh ◽  
Firdaus S. Dhabhar ◽  
Jamie M. Zeitzer ◽  
Booil Jo ◽  
...  

2010 ◽  
Author(s):  
Susan Sharp ◽  
Ashleigh Golden ◽  
Cheryl Koopman ◽  
Eric Neri ◽  
David Spiegel

2021 ◽  
Author(s):  
Jennifer A Ligibel ◽  
Luke Huebner ◽  
Hope S Rugo ◽  
Harold J Burstein ◽  
Debra L Toppmeyer ◽  
...  

Abstract Background Obesity and inactivity are associated with increased risk of cancer related- and overall mortality in breast cancer, but there are few data in metastatic disease. Methods CALGB 40502 was a randomized trial of first-line taxane-based chemotherapy for patients with metastatic breast cancer. Height and weight were collected at enrollment. After 299 patients enrolled, the study was amended to assess recreational physical activity (PA) at enrollment using the Nurses’ Health Study Exercise Questionnaire. Associations with progression-free survival (PFS) and overall survival (OS) were evaluated using stratified Cox modeling (strata included hormone receptor status, prior taxane, bevacizumab use, and treatment arm). Results 799 patients were enrolled and at the time of data lock, median follow-up was 60 months. At enrollment, median age was 56.7 years, 73.1% of participants had hormone receptor-positive cancers, 42.6% had obesity, and 47.6% engaged in less than 3 metabolic equivalents of task (MET)-hours of PA/week (&lt;1 hour of moderate PA). Neither baseline body mass index nor PA was statistically significantly associated with PFS or OS, although there was a marginally statistically significant increase in PFS (hazard ratio = 0.83, 95% confidence interval [CI] = 0.79, 1.02; p = .08) and OS (hazard ratio = 0.81, 95% CI = 0.65, 1.02; p = .07) in patients who reported PA greater than 9 MET-hours/week vs 0–9 MET-hours/week. Conclusions In a trial of first-line chemotherapy for metastatic breast cancer, rates of obesity and inactivity were high. There was no statistically significant relationship between body mass index and outcomes. More information is needed regarding the relationship between PA and outcomes.


2021 ◽  
Vol 11 ◽  
Author(s):  
Angeline Ginzac ◽  
Maureen Bernadach ◽  
Ioana Molnar ◽  
Martine Duclos ◽  
Emilie Thivat ◽  
...  

BackgroundThe standard care for HER2-positive breast cancer is chemotherapy plus a HER2-directed therapy. This can lead to treatment-induced cardiotoxicity. On the other hand, the practice of physical activity is known to improve cardiac function; thus HER2-positive breast cancer patients could draw particular benefit from physical activity during treatment. However, at the time of diagnosis for breast cancer, the majority of patients are insufficiently active according to physical activity recommendations of World Health Organisation, and it is difficult to remain or become active during the treatment. There is a lack of data in the literature on the optimal program to propose to patients to encourage them to be active during treatment. The aim of our study is to assess the feasibility of a home-based physical activity program during neoadjuvant chemotherapy and trastuzumab for HER2-positive breast cancer.MethodsThe APACAN2 study is a single-centre, non-randomized interventional trial. Patients with HER2-positive breast cancer treated with anthracycline-based neoadjuvant chemotherapy and trastuzumab are eligible for enrolment. The supervised home-based physical activity program takes place during neoadjuvant chemotherapy (NACT). It combines aerobic and strengthening exercises. The primary endpoint is the proportion of patients reaching the international physical activity recommendations, i.e. 150 minutes of moderate-intensity activity per week at the end of NACT. The study started in April 2018 and seventy patients are expected to be recruited.DiscussionIn the literature, the majority of studies on practice of physical activity in breast cancer focus on adjuvant chemotherapy or on the period after the end of treatment. To the best of our knowledge, the APACAN2 study is the first to evaluate a home-based physical activity program during neoadjuvant chemotherapy for HER2-positive breast cancer.Trial Registration NumberClinicaltrials.gov: NCT02963363, registered on July 11, 2016. Identifier with the French National Agency for the Safety of Medicines and Health Products N°ID RCB 2016-A01344-47, registered in August 2016. Protocol: version 8, 24 February 2021.


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