Efficacy of a Supervised Exercise Program on Pain, Physical Function, and Quality of Life in Patients With Breast Cancer: Protocol for a Randomized Clinical Trial

BackgroundBreast cancer is the second most common cancer in women worldwide. Treatments for this disease often result in side effects such as pain, fatigue, loss of muscle mass, and reduced quality of life. Physical exercise has been shown to effectively mitigate these side e...

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Main Authors: Jennifer García-Molina, Olalla Saiz-Vázquez, Montserrat Santamaría-Vázquez, Juan Hilario Ortiz-Huerta
Format: Article
Language:English
Published: JMIR Publications 2025-03-01
Series:JMIR Research Protocols
Online Access:https://www.researchprotocols.org/2025/1/e63891
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Summary:BackgroundBreast cancer is the second most common cancer in women worldwide. Treatments for this disease often result in side effects such as pain, fatigue, loss of muscle mass, and reduced quality of life. Physical exercise has been shown to effectively mitigate these side effects and improve the quality of life in patients with breast cancer. ObjectiveThis randomized clinical trial aims to evaluate the efficacy of a 12-week supervised exercise program on pain, physical function, and quality of life in female patients with cancer. MethodsThis randomized, double-blind clinical trial will recruit 325 participants, divided into an intervention group receiving the exercise program and a control group receiving standard care recommendations. Outcome measures, including pain (assessed via the Brief Pain Inventory), physical function (Disability of the Arm, Shoulder, and Hand Questionnaire), and quality of life (European Organization for Research and Treatment of Cancer QLQ-C30 and European Organization for Research and Treatment of Cancer QLQ-BR23), will be evaluated at baseline, immediately post intervention, and 12 weeks post intervention. Statistical analysis will involve repeated measures of ANOVA and MANOVA to determine the significance of the intervention’s effects across time points. ResultsRecruitment and data collection will commence in February of 2025, and data analysis is scheduled for completion at the end of 2025. No results are currently available ConclusionsPhysical exercise is anticipated to play a significant role in alleviating pain, enhancing physical function, and improving the quality of life in female patients with cancer. This study will provide robust evidence to support the integration of supervised exercise into standard care protocols for this population. Trial RegistrationClinicalTrials.gov NCT06618690; https://clinicaltrials.gov/ct2/show/NCT06618690 International Registered Report Identifier (IRRID)PRR1-10.2196/63891
ISSN:1929-0748