Tokyo, Dec. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060134) titled 'Effects of a Home-Based Exercise Digital Teaching Material and a Mobile App Walking Intervention for Post-Initial Treatment Breast Cancer Survivors' on Dec. 22.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Takasaki University of Health and Welfare

Condition: Condition - Breast Cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To examine the feasibility of delivering a walking intervention using digital teaching materials and a mobile application for individuals who have completed initial treatment for breast cancer, and to evaluate the acceptability, adherence, and preliminary effects of the intervention, with the goal of informing the design of a future randomized controlled trial. Basic objectives2 - Others

Intervention: Interventions/Control_1 - A single-group intervention will be conducted three times. The first session will involve explaining and implementing the exercise program. The second session will take place one month later, and the third session will be conducted three months after the first. To assess whether participants are able to continue the home-based exercise program, data from the mobile application, as well as changes in body composition, body weight, resilience, quality of life (QOL), and self-efficacy will be measured. During the second and third sessions, group discussions will be held to explore changes in motivation for continuing exercise and strategies participants have used to maintain their exercise habits.

Eligibility: Age-lower limit - 20 years-old

Gender - Female Key inclusion criteria - 1.Female breast cancer survivors who have completed initial treatments. 2.No restrictions on cancer stage. 3.Able to perform activities of daily living independently. 4.Within five years after completion of initial treatment. 5.Have not continuously engaged in vigorous physical activities. Such as running, aerobics, or swimming that induce sweating and shortness of breath for 30 minutes or more at least twice per week for the past year. 6.Regular users of a smartphone in daily life. 7.Have received medical clearance from a physician to participate in exercise. 8.Physically and mentally capable of understanding the study information sheet and responding to the study questionnaires. Key exclusion criteria - 1.If a participant, after providing written informed consent and enrolling in the study, expresses the intention to withdraw consent. 2.If the participant experiences health deterioration or cancer recurrence requiring medical treatment. Target Size - 24

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 31 Day Anticipated trial start date - 2026 Year 02 Month 01 Day Last follow-up date - 2026 Year 04 Month 25 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068774

Disclaimer: Curated by HT Syndication.