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Life sciences · Interventional Study
ClinicalTrials.gov · October 8, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07864909). This is a study registration, not published results. Lead sponsor: International Hellenic University. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 115 participants (ACTUAL). Conditions: Breast Cancer. Interventions: BEHAVIORAL: Nurse-Led Educational Intervention. Primary outcome measures: Change from Baseline in Depression Anxiety Stress Scales - 21 Items (DASS-21) Score , Baseline (prior to initiation of chemotherapy), week 9 (mid-chemotherapy), and at the end of chemotherapy (week 18 for participants receiving a 6-cycle regimen or week 21 for participants receiving an 8-cycle regimen); Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score , Baseline (prior to initiation of chemotherapy), week 9 (mid-chemotherapy), and at the end of chemotherapy (week 18 for participants receiving a 6-cycle regimen or week 21 for participants receiving an 8-cycle regimen); Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module 23 (EORTC QLQ-BR23) Scores , Baseline (prior to initiation of chemotherapy), week 9 (mid-chemotherapy), and at the end of chemotherapy (week 18 for participants receiving a 6-cycle regimen or week 21 for participants receiving an 8-cycle regimen); Change from Baseline in Brief Fatigue Inventory (BFI) Score , Baseline (prior to initiation of chemotherapy), week 9 (mid-chemotherapy), and at the end of chemotherapy (week 18 for participants receiving a 6-cycle regimen or week 21 for participants receiving an 8-cycle regimen); Change from Baseline in Total Physical Activity Measured by the International Physical Activity Questionnaire Short Form (IPAQ-SF) , Baseline (prior to initiation of chemotherapy), week 9 (mid-chemotherapy), and at the end of chemotherapy (week 18 for participants receiving a 6-cycle regimen or week 21 for participants receiving an 8-cycle regimen). Brief summary: The goal of this clinical trial is to investigate how a nurse-led physical activity education program affects quality of life, fatigue, anxiety, depression, stress, and physical activity in women with breast cancer during chemotherapy. The main questions it aims to answer are: Does quality of life, fatigue, stress, anxiety, depression, and physical activity change over time for patients who do not receive the educational program? Does quality of life, fatigue, anxiety, depression, and physical activity change over time for patients who do receive the physical activity education program? Is there a difference between the groups in the percentage of change from the start of chemotherapy to the middle and the end? Is there a difference between the groups in the adjusted absolute changes from the start of chemotherapy to the middle and the end?