scholarly journals Feasibility and Health Benefits of an Individualized Physical Activity Intervention in Women With Metastatic Breast Cancer: Intervention Study (Preprint)

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


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


2017 ◽  
Vol 49 ◽  
pp. 37-43 ◽  
Author(s):  
Hannah M. Fisher ◽  
Jamie M. Jacobs ◽  
Chloe J. Taub ◽  
Suzanne C. Lechner ◽  
John E. Lewis ◽  
...  

2020 ◽  
Author(s):  
Siobhan Phillips ◽  
Payton Solk ◽  
Whitney Welch ◽  
Lisa Auster-Gussman ◽  
Marilyn Lu ◽  
...  

BACKGROUND Increased incidence and life expectancy have resulted in a growing population of patients with metastatic breast cancer, and these patients experience high rates of morbidity and premature mortality. Increased physical activity (PA) is consistently associated with improved health and disease outcomes among early-stage survivors. However, there is a paucity of research on PA in patients with metastatic breast cancer, and existing PA interventions have exhibited low feasibility because of their focus on intense PA and/or requirement of on-site visits. Mobile health (mHealth)–based PA interventions may be particularly useful for patients with metastatic breast cancer because they allow for remote monitoring, which facilitates individual tailoring of PA recommendations to patients’ abilities and may minimize participant burden. However, no studies have examined mHealth PA interventions in patients with metastatic breast cancer. OBJECTIVE We aim to address these critical research gaps by testing a highly tailored technology-based intervention to promote PA of any intensity (ie, light, moderate, or vigorous) by increasing daily steps in patients with metastatic breast cancer. The primary aim of this study is to test the feasibility and acceptability of the Fit2ThriveMB intervention. We will also examine outcome patterns suggesting the efficacy of Fit2ThriveMB on symptom burden, quality of life, and functional performance. METHODS The Fit2ThriveMB trial is a two-arm pilot randomized controlled trial that will compare the effects of a smartphone-delivered, home-based PA intervention and an attention-control education condition on PA and quality of life in low-active female patients with metastatic breast cancer. A subsample (n=25) will also complete functional performance measures. This innovative trial will recruit 50 participants who will be randomized into the study’s intervention or control arm. The intervention will last 12 weeks. The Fit2ThriveMB intervention consists of a Fitbit, coaching calls, and the Fit2ThriveMB smartphone app that provides self-monitoring, a tailored goal-setting tool, real-time tailored feedback, app notifications, and a group message board. Assessments will occur at baseline and post intervention. RESULTS The Fit2ThriveMB study is ongoing. Data collection ended in February 2021. CONCLUSIONS Data from this study will provide the preliminary effect sizes needed to assemble an intervention that is to be evaluated in a fully powered trial. In addition, these data will provide essential evidence to support the feasibility and acceptability of using a technology-based PA promotion intervention, a scalable strategy that could be easily integrated into care, among patients with metastatic breast cancer. CLINICALTRIAL ClinicalTrials.gov NCT04129346; https://clinicaltrials.gov/ct2/show/NCT04129346 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/24254


10.2196/24254 ◽  
2021 ◽  
Vol 10 (4) ◽  
pp. e24254
Author(s):  
Siobhan Phillips ◽  
Payton Solk ◽  
Whitney Welch ◽  
Lisa Auster-Gussman ◽  
Marilyn Lu ◽  
...  

Background Increased incidence and life expectancy have resulted in a growing population of patients with metastatic breast cancer, and these patients experience high rates of morbidity and premature mortality. Increased physical activity (PA) is consistently associated with improved health and disease outcomes among early-stage survivors. However, there is a paucity of research on PA in patients with metastatic breast cancer, and existing PA interventions have exhibited low feasibility because of their focus on intense PA and/or requirement of on-site visits. Mobile health (mHealth)–based PA interventions may be particularly useful for patients with metastatic breast cancer because they allow for remote monitoring, which facilitates individual tailoring of PA recommendations to patients’ abilities and may minimize participant burden. However, no studies have examined mHealth PA interventions in patients with metastatic breast cancer. Objective We aim to address these critical research gaps by testing a highly tailored technology-based intervention to promote PA of any intensity (ie, light, moderate, or vigorous) by increasing daily steps in patients with metastatic breast cancer. The primary aim of this study is to test the feasibility and acceptability of the Fit2ThriveMB intervention. We will also examine outcome patterns suggesting the efficacy of Fit2ThriveMB on symptom burden, quality of life, and functional performance. Methods The Fit2ThriveMB trial is a two-arm pilot randomized controlled trial that will compare the effects of a smartphone-delivered, home-based PA intervention and an attention-control education condition on PA and quality of life in low-active female patients with metastatic breast cancer. A subsample (n=25) will also complete functional performance measures. This innovative trial will recruit 50 participants who will be randomized into the study’s intervention or control arm. The intervention will last 12 weeks. The Fit2ThriveMB intervention consists of a Fitbit, coaching calls, and the Fit2ThriveMB smartphone app that provides self-monitoring, a tailored goal-setting tool, real-time tailored feedback, app notifications, and a group message board. Assessments will occur at baseline and post intervention. Results The Fit2ThriveMB study is ongoing. Data collection ended in February 2021. Conclusions Data from this study will provide the preliminary effect sizes needed to assemble an intervention that is to be evaluated in a fully powered trial. In addition, these data will provide essential evidence to support the feasibility and acceptability of using a technology-based PA promotion intervention, a scalable strategy that could be easily integrated into care, among patients with metastatic breast cancer. Trial Registration ClinicalTrials.gov NCT04129346; https://clinicaltrials.gov/ct2/show/NCT04129346 International Registered Report Identifier (IRRID) DERR1-10.2196/24254


Oncology ◽  
2018 ◽  
Vol 95 (3) ◽  
pp. 188-191 ◽  
Author(s):  
Sébastien Landry ◽  
Guillaume Chasles ◽  
Yoann Pointreau ◽  
Hugues Bourgeois ◽  
Sébastien Boyas

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e13075-e13075
Author(s):  
Sofía Ruíz ◽  
Bella Pajares ◽  
Maria-Jose Bermejo-Perez ◽  
Cristina Roldán Jiménez ◽  
Antonio Cuesta Vargas ◽  
...  

e13075 Background: The safety, feasibility and benefit of physical activity is robust in adjuvant breast cancer, but as far as we know, there is little information on the feasibility and benefit of exercise in women with advanced breast cancer. The objective of our study is to analyze the feasibility and impact on fatigue, quality of life and functionality of an individualized, prospective and supervised exercise program in a group of patients with metastatic breast cancer. Methods: A prospective study on 30 metastatic breast cancer patients who were recruited as volunteers between February 2018 and April 2019 by Medical Oncologists from the Medical Oncology Unit at University Clinical Hospital Virgen de la Victoria (Malaga, Spain). Participants included in this study were patients aged between 34 and 71 years old and all had metastatic breast cancer, not amenable to curative treatment. The intervention was a twelve-week Therapeutic Exercise and Education Programme delivered by a physiotherapist. The intervention was preceded by a physical assessment of the musculoskeletal system. The outcomes were cancer-related fatigue, quality of life and functional outcomes (patient- reported and other measured by investigators). Results: Of the 30 patients initially recruited, only 11 of them completed the program with an attendance greater or equal to 17 sessions (75% of assistance). Most of patients who dropped (19), did it because of personal matters, not related to disease progression. Regarding patients who completed the completion of physical activity program (n = 11), the majority were treated on first line of treatment with hormonal receptors positive tumors and bone metastasis. After the intervention, no major changes were observed in cancer-related fatigue, quality of life and several patients-reported outcomes, although an improvement in functionality was observed, in investigator-measured parameters (30-STS and adapted burpees). Conclusions: Our study shows that a supervised and individualized tailored physical activity program in metastatic breast cancer patients is safe and feasible, although more studies are needed to analyse its impact on improving functional parameters, fatigue and quality of life.


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