scholarly journals Feasibility and efficacy of a supervised home-based physical exercise program for metastatic cancer patients receiving oral targeted therapy: study protocol for the phase II/III - UNICANCER SdS 01 QUALIOR trial

BMC Cancer ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Florence Joly ◽  
Claudia Lefeuvre-Plesse ◽  
Claire Garnier-Tixidre ◽  
Carole Helissey ◽  
Nathalie Menneveau ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Targeted Therapy ◽  
Physical Exercise ◽  
Cancer Patients ◽  
Phase Ii ◽  
Metastatic Cancer ◽  
Activity Program ◽  
Home Based

Abstract Background Currently, oral targeted therapies are known to be effective and are frequently used to treat metastatic cancer patients, but fatigue is a frequently reported early side effect of these treatments. This fatigue may impact the patient’s treatment adherence and result in a negative impact on quality of life. Physical exercise significantly improved the general well-being and quality of life of advanced cancer patients. However, there is no specific physical activity program adapted for patients with advanced disease. Methods QUALIOR is a two-part, randomized, open-label, and multicenter with two arms phase II/III trial. Patients (phase II: n = 120; phase III: n = 312) with metastatic cancer (breast cancer, kidney cancer, lung cancer, and other cancers [including but not limited to colon cancer, melanoma, sarcoma, or hepatocarcinoma]) treated with a first- or second-line oral targeted therapy without chemotherapy will be included. Patients will be randomized (2:1) to a 3-month supervised home-based standardized physical activity program or to a recommended adapted physical activity (via a booklet). The primary objective of the phase II is to evaluate the feasibility of the supervised program. The primary objective of the phase III is the evaluation of the benefit of the supervised home-based program compare to the recommended program in terms of fatigue and quality of life at 3 months. The secondary objectives aim to evaluate the impact of the supervised program on fatigue over time, pain, physical capacities, psychosocial and cognitive functions, general quality of life, frequency of dose reduction and patients’ adherence to the targeted therapy, overall survival, and progression-free survival. This study will also evaluate the medico-economic impact of supervised program compared to the recommended adapted physical activity program. Discussion The aim of this study is to evaluate home-based physical exercise program for metastatic cancer patients treated with oral targeted therapies to help patients to cope with fatigue and improve quality of life. Trial registration This trial was registered in ClinicalTrials.gov since May 2017 (NCT03169075).

A phase II-III, multicenter, randomized, open study evaluating the feasibility and efficacy of a supervised home-based standard physical exercise program for metastatic cancer patients receiving oral targeted therapy: The UNICANCER SdS 01 QUALIOR study (ID-RCB: 2015-A01922-47).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS10126-TPS10126
Author(s):  
Florence Joly Lobbedez ◽  
Laurence Vanlemmens ◽  
Jean-Marc Descotes ◽  
Sophie Abadie-Lacourtoisie ◽  
Claude Boiron ◽  
...  
Keyword(s):  
Physical Activity ◽  
Physical Exercise ◽  
Cancer Patients ◽  
Phase Ii ◽  
Metastatic Cancer ◽  
Exercise Program ◽  
Well Being ◽  
Phase Iii ◽  
Ethic Committee Approval ◽  
Home Based

TPS10126 Background: Fatigue is a frequent side effect with oral targeted therapies (OTT). Physical activity has been reported to improve fatigue and quality of life (QoL). However, few studies focused on metastatic cancer patients and mainly among patients treated with chemotherapy. Furthermore, recent guidelines recommend evaluation and optimization of standardized exercise programs. The aim of our study is to evaluate home-based standard physical exercise program (SPEP) for metastatic cancer patients treated with OTT. Methods: This phase II-III study will randomize (2:1) patients starting first-line OTT for metastatic cancer between an individualized SPEP supervised by a personal coach, and recommended physical exercises via a booklet. Eligible patients will have received ≤2 lines of metastatic chemotherapy, ECOG PS ≤2, controlled pain (VAS < 3/10), and life expectancy ≥3 months. The phase II part (120 patients) will evaluate the feasibility of a 3-month SPEP using the rate of patients performing ≥50% of SPEP (2-stage Fleming: one-sided α = 5%; β = 85%). An interim analysis is planned after the phase II. The phase III will compare the efficacy of an SPEP as opposed to recommendations to reduce fatigue and/or improve physical well-being (PWB) dimensions of QoL (evaluated with FACT-G and FACT-F questionnaires). To show a difference of ≥5 points in PWB and 2.5 for fatigue (α = 2.5%; β = 80%), 312 patients are required in the phase III trial. . Secondary objectives include: PFS, OS, other dimensions of QoL, tolerability and observance of OTT, change in body composition, physical benefits, and a medico-economic study. The SPEP was developed by specialized coaches involved in physical activity and cancer. The study has Ethic committee approval and accrual is planned in 18 French centers in April 2017, for 30 months. This is the first randomized trial dedicated to patients with metastatic cancer treated with OTT evaluating the feasibility and the efficacy of a well design home based SPEP on fatigue and physical well-being.

scholarly journals Can a Home-based Cardiac Physical Activity Program Improve the Physical Function Quality of Life in Children with Fontan Circulation?

2016 ◽  
Vol 11 (2) ◽  
pp. 175-182 ◽  
Author(s):  
Roni M. Jacobsen ◽  
Salil Ginde ◽  
Kathleen Mussatto ◽  
Jennifer Neubauer ◽  
Michael Earing ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Physical Function ◽  
Fontan Circulation ◽  
Physical Activity Program ◽  
Activity Program ◽  
Home Based

Influence of an Adapted Physical Activity Program on Self-Esteem and Quality of Life of Breast Cancer Patients after Mastectomy

Oncology ◽  
2018 ◽  
Vol 95 (3) ◽  
pp. 188-191 ◽  
Author(s):  
Sébastien Landry ◽  
Guillaume Chasles ◽  
Yoann Pointreau ◽  
Hugues Bourgeois ◽  
Sébastien Boyas
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Physical Activity ◽  
Cancer Patients ◽  
Self Esteem ◽  
Physical Activity Program ◽  
Breast Cancer Patients ◽  
Adapted Physical Activity ◽  
Activity Program

scholarly journals “Randomized trial of physical activity on quality of life and lung cancer biomarkers in patients with advanced stage lung cancer: a pilot study”

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Brett C. Bade ◽  
Geliang Gan ◽  
Fangyong Li ◽  
Lingeng Lu ◽  
Lynn Tanoue ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Lung Cancer ◽  
Randomized Trial ◽  
Cancer Biomarkers ◽  
Advanced Stage ◽  
Home Based ◽  
Advanced Stage Lung Cancer ◽  
Stage Lung Cancer

Abstract Background Lung cancer survivors need more options to improve quality of life (QoL). It is unclear to what extent patients with advanced stage disease are willing to participate in home-based physical activity (PA) and if these interventions improve QoL. The goal of our study was to determine interest in participating in our 3-month home-based walking regimen in patients with advanced stage lung cancer. We used a randomized design to evaluate for potential benefit in PA and patient-reported outcomes. Methods We performed an open-label, 1:1 randomized trial in 40 patients with stage III/IV non-small cell lung cancer (NSCLC) evaluating enrollment rate, PA, QoL, dyspnea, depression, and biomarkers. Compared to usual care (UC), the intervention group (IG) received an accelerometer, in-person teaching session, and gain-framed text messages for 12 weeks. Results We enrolled 56% (40/71) of eligible patients. Participants were on average 65 years and enrolled 1.9 years from diagnosis. Most patients were women (75%), and receiving treatment (85%) for stage IV (73%) adenocarcinoma (83%). A minority of patients were employed part-time or full time (38%). Both groups reported low baseline PA (IG mean 37 (Standard deviation (SD) 46) vs UC 59 (SD 56) minutes/week; p = 0.25). The IG increased PA more than UC (mean change IG + 123 (SD 212) vs UC + 35 (SD 103) minutes/week; p = 0.051)). Step count in the IG was not statistically different between baseline (4707 step/day), week 6 (5605; p = 0.16), and week 12 (4606 steps/day; p = 0.87). The intervention improved EORTC role functioning domain (17 points; p = 0.022) with borderline improvement in dyspnea (− 13 points; p = 0.051) compared to UC. In patients with two blood samples (25%), we observed a significant increase in soluble PD-1 (219.8 (SD 54.5) pg/mL; p < 0.001). Conclusions Our pilot trial using a 3-month, home-based, mobile health intervention enrolled over half of eligible patients with stage III and IV NSCLC. The intervention increased PA, and may improve several aspects of QoL. We also identified potential biomarker changes relevant to lung cancer biology. Future research should use a larger sample to examine the effect of exercise on cancer biomarkers, which may mediate the association between PA and QoL. Clinical trial registration Clinicaltrials.gov (NCT03352245).

scholarly journals Acceptability, Feasibility and Preliminary Evaluation of a Novel, Personalised, Home-Based Physical Activity Intervention for Chronic Heart Failure (Active-at-Home-HF): a Pilot Study

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Nduka C. Okwose ◽  
Leah Avery ◽  
Nicola O’Brien ◽  
Sophie Cassidy ◽  
Sarah J. Charman ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Heart Failure ◽  
Pilot Study ◽  
Chronic Heart Failure ◽  
Physical Activity Intervention ◽  
Step Count ◽  
Home Based ◽  
At Home

Abstract Purpose Less than 10% of heart failure patients in the UK participate in cardiac rehabilitation programmes. The present pilot study evaluated feasibility, acceptability and physiological effects of a novel, personalised, home-based physical activity intervention in chronic heart failure. Methods Twenty patients (68 ± 7 years old, 20% females) with stable chronic heart failure due to reduced left ventricular ejection fraction (31 ± 8 %) participated in a single-group, pilot study assessing the feasibility and acceptability of a 12-week personalised home-based physical activity intervention aiming to increase daily number of steps by 2000 from baseline (Active-at-Home-HF). Patients completed cardiopulmonary exercise testing with non-invasive gas exchange and haemodynamic measurements and quality of life questionnaire pre- and post-intervention. Patients were supported weekly via telephone and average weekly step count data collected using pedometers. Results Forty-three patients were screened and 20 recruited into the study. Seventeen patients (85%) completed the intervention, and 15 (75%) achieved the target step count. Average step count per day increased significantly from baseline to 3 weeks by 2546 (5108 ± 3064 to 7654 ± 3849, P = 0.03, n = 17) and was maintained until week 12 (9022 ± 3942). Following completion of the intervention, no adverse events were recorded and quality of life improved by 4 points (26 ± 18 vs. 22 ± 19). Peak exercise stroke volume increased by 19% (127 ± 34 vs. 151 ± 34 m/beat, P = 0.05), while cardiac index increased by 12% (6.8 ± 1.5 vs. 7.6 ± 2.0 L/min/m2, P = 0.19). Workload and oxygen consumption at anaerobic threshold also increased by 16% (49 ± 16 vs. 59 ± 14 watts, P = 0.01) and 10% (11.5 ± 2.9 vs. 12.8 ± 2.2 ml/kg/min, P = 0.39). Conclusion The Active-at-Home-HF intervention is feasible, acceptable and effective for increasing physical activity in CHF. It may lead to improvements in quality of life, exercise tolerance and haemodynamic function. Trial Registration www.clinicaltrials.gov NCT0367727. Retrospectively registered on 17 September 2018.

Feasibility of a telemedicine lifestyle-based rehabilitation program (HEAL) for gynecologic cancer patients.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e24033-e24033
Author(s):  
Nathalie Dauphin McKenzie ◽  
Nnamdi Ifekandu Gwacham ◽  
Julie W. Pepe ◽  
Sarfraz Ahmad ◽  
James Erasmus Kendrick ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Cancer Survivors ◽  
Social Integration ◽  
Stress Management ◽  
Cancer Patients ◽  
Gynecologic Cancer ◽  
Lifestyle Medicine ◽  
Rehabilitation Team

e24033 Background: General health related factors such as obesity, unhealthy diets disproportionate with sugary and highly processed foods, inactivity, and smoking have repeatedly been shown to negatively impact survival and quality of life outcomes in cancer survivors. The Healthy Eating Active Lifestyle (HEAL) – GYN “rehabilitation” cancer program was developed to provide intensive group lifestyle training on exercise, nutrition, sleep, social integration, and stress management via a telemedicine platform. The aim of this study was to determine the feasibility of such an intervention and its tolerability, in addition to its impact on short-term quality of life for gynecologic cancer patients. Methods: HEAL – GYN consists of 8 weekly group sessions offering experiential instruction and personalized goal setting for patients with diagnosis of gynecologic cancer. Components are drawn from the tenets of lifestyle medicine. An oncologist certified in lifestyle medicine along with a multidisciplinary rehabilitation team addressed diet, physical activity, strategies for sleep and stress management, smoking cessation, and alcohol intake. The intervention included training to address unmet psychologic, emotional, physical, sexual, social, and spiritual needs common to cancer survivors. American College of Lifestyle Medicine questionnaires were administered, utilizing Likert scales (1-5) in a pre- and post- fashion to assess improvements in physical activity levels, dietary habits, sleep hygiene, and quality of life. Medical records were reviewed including anthropometric data. Results: 26 patients have enrolled thus far, and we report outcomes on the first 20 participants. The mean age was 58.8 years; 22 were Caucasian, and 7 were on maintenance therapies for gynecologic cancers. Average total severity of reported symptoms (scale = 100 points) on a general medical symptom questionnaire (MSQ) decreased by 22% (61 vs 48). Eight patients reported increased perceived levels of health and 6 had stable perception of health. There were also notable improvements from baseline in item assessments of eating behavior (34%), perceived stress (20%), and resilience (21%). Patients also reported a notable trend towards improvement in anxiety (35%) and depression (34%), as well as social integration and connectedness (30%). 100% of participants would “highly recommend the program” and none complained of stress or altered mood associated with online instruction. Conclusions: The telemedicine HEAL – GYN peri-habilitation program is feasible and well tolerated. In addition, the program may improve quality of life and may prevent further decline for those on treatment or maintenance therapy. These preliminary findings support continued investigation of a telemedicine healthy lifestyle peri-habilitative program.

Sign in / Sign up

Export Citation Format

Share Document