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Breast CancerNCT07864909

Physical Activity Education and Quality of Life Study in Breast Cancer Chemotherapy Patients

A study testing Nurse-Led Educational Intervention in people with Breast Cancer, run by International Hellenic University at 1 site in Greece.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Nurse-Led Educational Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
1 siteGreece
Study dates
2 Jul 2024to Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female adults aged 18 years or older
  • Capable of understanding the Greek language
  • Histologically diagnosed with breast cancer
  • Scheduled to undergo chemotherapy

Who cannot join

  • Severe unstable psychiatric illness

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • International Hellenic University

    Thermi

Other trials in Greece

About this study

Official title: A Randomized Study of the Quality of Life of Women With Breast Cancer Undergoing Chemotherapy Following a Nurse-Led Educational Intervention to Enhance Physical Activity

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?

Read the detailed description

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.

Conditions
Breast Cancer
Being tested
Nurse-Led Educational Intervention
Keywords
Nurse- Led Physical Activity Education Intervention
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nurse-Led Educational InterventionBehavioural

    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.

Study groups in NCT07864909
Study groupRoleWhat they receive
The Nurse-Led Physical Activity Intervention GroupExperimentalThe 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.
Receives: Behavioral: Nurse-Led Educational Intervention
Control groupNo interventionParticipants do not receive the Nurse-Led Physical Activity Intervention during chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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)

  2. 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.

    Measured: 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)

  3. 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.

    Measured: 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)

  4. 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.

    Measured: 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)

  5. 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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2026
  2. Study start2 Jul 2024
  3. Primary completion30 Apr 2026
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07864909
Sponsor's protocol ID
6-01/07/2024
Status last verified
Sep 2026
First submitted
20 Sep 2026
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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)

Publications

  • Strupp J, Dose C, Kuhn U, Galushko M, Duesterdiek A, Ernstmann N, Pfaff H, Ostgathe C, Voltz R, Golla H. Analysing the impact of a case management model on the specialised palliative care multi-professional team. Support Care Cancer. 2018 Feb;26(2):673-679. doi: 10.1007/s00520-017-3893-3. Epub 2017 Sep 17.

    PubMed 28920137

  • Zeng K, He B, Yang BB, Xu T, Chen X, Xu M, Liu X, Sun H, Pan Y, Wang S. The pro-metastasis effect of circANKS1B in breast cancer. Mol Cancer. 2018 Nov 19;17(1):160. doi: 10.1186/s12943-018-0914-x.

    PubMed 30454010

  • Gerber LH. Cancer-Related Fatigue: Persistent, Pervasive, and Problematic. Phys Med Rehabil Clin N Am. 2017 Feb;28(1):65-88. doi: 10.1016/j.pmr.2016.08.004.

    PubMed 27913001

  • Maltser S, Cristian A, Silver JK, Morris GS, Stout NL. A Focused Review of Safety Considerations in Cancer Rehabilitation. PM R. 2017 Sep;9(9S2):S415-S428. doi: 10.1016/j.pmrj.2017.08.403.

    PubMed 28942913

  • Stout NL, Baima J, Swisher AK, Winters-Stone KM, Welsh J. A Systematic Review of Exercise Systematic Reviews in the Cancer Literature (2005-2017). PM R. 2017 Sep;9(9S2):S347-S384. doi: 10.1016/j.pmrj.2017.07.074.

    PubMed 28942909

  • Hilfiker R, Meichtry A, Eicher M, Nilsson Balfe L, Knols RH, Verra ML, Taeymans J. Exercise and other non-pharmaceutical interventions for cancer-related fatigue in patients during or after cancer treatment: a systematic review incorporating an indirect-comparisons meta-analysis. Br J Sports Med. 2018 May;52(10):651-658. doi: 10.1136/bjsports-2016-096422. Epub 2017 May 13.

    PubMed 28501804

  • Nunes AF, Bezerra CO, Custodio JDS, Friedrich CF, Oliveira IS, Lunardi AC. Clinimetric Properties of the Brief Fatigue Inventory Applied to Oncological Patients Hospitalized for Chemotherapy. J Pain Symptom Manage. 2019 Feb;57(2):297-303. doi: 10.1016/j.jpainsymman.2018.10.508. Epub 2018 Nov 1.

    PubMed 30391653

  • Reigle BS, Zhang B. Women's Rehabilitation Experiences Following Breast Cancer Surgery. Rehabil Nurs. 2018 Jul/Aug;43(4):195-200. doi: 10.1097/rnj.0000000000000168.

    PubMed 29957696

  • Mallios, S., Agnantis, N., Pavlidis, N., Kappas, A., Kriaras, I., & Geroulanos, S. (2006). The history of breast cancer. Archives of Hellenic Medicine, 23(3), 260-278.

  • Sprangers MA, Groenvold M, Arraras JI, Franklin J, te Velde A, Muller M, Franzini L, Williams A, de Haes HC, Hopwood P, Cull A, Aaronson NK. The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol. 1996 Oct;14(10):2756-68. doi: 10.1200/JCO.1996.14.10.2756.

    PubMed 8874337

  • Lyrakos, G. N., Arvaniti, C., Smyrnioti, M., & Kostopanagiotou, G. (2011). Translation and validation study of the Depression Anxiety Stress Scale in the Greek general population and in a psychiatric patient's sample. European Psychiatry, 26, 1731. https://doi.org/10.1016/S0924-9338(11)73435-6.

  • Riddell S. The emperor of all maladies: A biography of cancer. J Clin Invest. 2011 Jan 4;121(1):5. doi: 10.1172/JCI45710. Epub 2011 Jan 4. PMCID: PMC3007170.

  • Papathanasiou G, Georgoudis G, Papandreou M, Spyropoulos P, Georgakopoulos D, Kalfakakou V, Evangelou A. Reliability measures of the short International Physical Activity Questionnaire (IPAQ) in Greek young adults. Hellenic J Cardiol. 2009 Jul-Aug;50(4):283-94.

    PubMed 19622498

  • Sprangers MA, Cull A, Groenvold M, Bjordal K, Blazeby J, Aaronson NK. The European Organization for Research and Treatment of Cancer approach to developing questionnaire modules: an update and overview. EORTC Quality of Life Study Group. Qual Life Res. 1998 May;7(4):291-300. doi: 10.1023/a:1024977728719.

    PubMed 9610213

  • van Leeuwen M, Husson O, Alberti P, Arraras JI, Chinot OL, Costantini A, Darlington AS, Dirven L, Eichler M, Hammerlid EB, Holzner B, Johnson CD, Kontogianni M, Kjaer TK, Morag O, Nolte S, Nordin A, Pace A, Pinto M, Polz K, Ramage J, Reijneveld JC, Serpentini S, Tomaszewski KA, Vassiliou V, Verdonck-de Leeuw IM, Vistad I, Young TE, Aaronson NK, van de Poll-Franse LV; EORTC QLG. Understanding the quality of life (QOL) issues in survivors of cancer: towards the development of an EORTC QOL cancer survivorship questionnaire. Health Qual Life Outcomes. 2018 Jun 4;16(1):114. doi: 10.1186/s12955-018-0920-0.

    PubMed 29866185

Questions about this trial

What is this clinical trial studying?

A study testing Nurse-Led Educational Intervention in people with Breast Cancer, run by International Hellenic University at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Depression Anxiety Stress Scales - 21 Items (DASS-21) Score (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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07864909, which also lists 46 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.

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