An interventional study of Nurse-Led Educational Intervention in Breast Cancer, sponsored by International Hellenic University. Active, not recruiting at 1 site in Greece. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by International Hellenic University · Not applicable, Interventional, and Supportive care
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?
Background: The quality of life of breast cancer patients is a dynamic indicator influenced by multiple factors. Despite therapeutic advances, the management of symptoms such as fatigue, psychological distress, pain, lymphedema, and sexual dysfunction remains a significant challenge, with patients frequently reporting numerous unmet needs. A cancer diagnosis holistically affects an individual's life, impacting physical, psychological, social, and spiritual dimensions.
In this context, systematic exercise proves highly beneficial for breast cancer patients before, during, and after the completion of treatments, functioning as a complementary therapy. It contributes effectively to the management of side effects, enhances physical functioning, reduces fatigue, anxiety, and pain, and improves overall quality of life. However, previous studies demonstrate that patients often lack the necessary support and guidance regarding physical activity during their treatment.
Aim: This randomized trial aims to investigate whether a nurse-led physical activity educational and enhancement intervention can alter general and breast cancer-specific quality of life, fatigue, depression, anxiety, stress, and physical activity of women with breast cancer at the beginning, middle, and completion of their chemotherapy.
Method: Breast cancer patients undergoing chemotherapy are randomly assigned to either a control group receiving usual care or the intervention group receiving usual care plus an educational intervention aimed at enhancing physical activity. Outcomes will be assessed at baseline, at the midpoint, and at the completion of chemotherapy.Standardized assessment tools are used to measure general quality of life, breast cancer-specific quality of life, fatigue, depression, anxiety, stress, and physical activity.
12,820 studies on the registry are indexed under Breast Neoplasms; 2,923 are open to participants now.
This study's enrollment of 115 is above the median of 72 across 9,498 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →International Hellenic University is the lead sponsor of 19 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Severe unstable psychiatric illness
The Nurse-Led Physical Activity Intervention Group will receive usual care in addition to an educational intervention designed to enhance physical activity among women with breast cancer undergoing chemotherapy. At baseline, participants allocated to the intervention group will receive the first nurse-led session, lasting approximately 30 minutes, which will aim to promote physical activity during chemotherapy by providing scientific evidence, supporting cognitive reframing, and strengthening self-efficacy. The session will also include personalized counselling based on motivational interviewing, in order to explore participants' needs, perceived barriers, facilitators, and exercise preferences, and to identify practical ways of integrating physical activity into daily life. During subsequent chemotherapy cycles, participants will receive brief, targeted nurse-led follow-up interventions based on the 5 As model, lasting approximately 5-15 minutes.
Behavioral: Nurse-Led Educational Intervention
Participants do not receive the Nurse-Led Physical Activity Intervention during chemotherapy
The educational intervention is designed to help women with breast cancer stay physically active while going through chemotherapy by combining practical learning with personal skill-building. Rather than just giving instructions, the program works by sharing clear scientific knowledge and helping patients shift their mindset through cognitive reframing. To make the process manageable, the training focuses on building self-efficacy step-by-step through "small wins" and teaching participants how to track their own progress. It also provides guidance on managing expectations and emotions so patients can protect themselves from feelings of failure and guilt if they miss a goal. Ultimately, the approach centers on strengthening self-care and developing everyday habits that make physical activity feel achievable during treatment.
Change from Baseline in Depression Anxiety Stress Scales - 21 Items (DASS-21) Score
Assessment of changes in psychological distress using the Depression Anxiety Stress Scales - 21 Items (DASS-21).The instrument includes 21 items rated from 0 to 3. Each subscale (Depression, Anxiety, and Stress) consists of 7 items; the sum of item scores is multiplied by 2, resulting in subscale scores ranging from 0 to 42. Higher scores indicate more severe symptoms.
Time frame: 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
Assessment of changes in quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), which includes a Global Health Status/Quality of Life scale, five functional scales (physical, role, emotional, cognitive, and social functioning), and symptom scales/single-item measures. All scales are scored from 0 to 100. For the Global Health Status/Quality of Life and functional scales, higher scores indicate better quality of life or functioning. For symptom scales and single-item measures, higher scores indicate greater symptom burden and worse outcomes.
Time frame: 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
Assessment of changes in breast cancer-specific quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module 23 (EORTC QLQ-BR23), which includes functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and symptom scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). All scales are scored from 0 to 100. For functional scales, higher scores indicate better functioning. For symptom scales, higher scores indicate greater symptom burden and worse outcomes.
Time frame: 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
Assessment of changes in cancer-related fatigue using the Brief Fatigue Inventory (BFI). The BFI consists of 9 items rated on an 11-point scale from 0 to 10. Three items assess fatigue severity and six items assess the extent to which fatigue interferes with daily functioning. The global fatigue score is calculated as the mean of all completed items and ranges from 0 to 10. Higher scores indicate more severe fatigue and greater interference with daily activities.
Time frame: 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)
Assessment of changes in physical activity levels using the International Physical Activity Questionnaire Short Form (IPAQ-SF), which assesses walking, moderate-intensity physical activity, vigorous-intensity physical activity, and sitting time during the previous 7 days. Total physical activity is calculated and expressed as metabolic equivalent task (MET)-minutes per week (minimum value: 0; no fixed maximum value). Higher values indicate higher levels of physical activity. Participants may be classified as having low, moderate, or high physical activity levels according to the IPAQ scoring protocol.
Time frame: 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)
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — No (IPD sharing is not planned as patient consent and ethical approvals do not cover broader data distribution outside the primary research team, and the protocol does not include provisions for an anonymized data repository)
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
International Hellenic University