Breast Cancer FemaleNCT06730815
Body Image and Physical Activity of Women with Breast Cancer
An observational study of Breast Cancer Female and Physical Inactivity, run by University of Pecs at 2 sites in Hungary.
Trial summary
The goal of this self-initiated questionnaire-based follow-up clinical trial is to map the body image and physical activity of Hungarian women treated for breast cancer. The main questions it aims to answer are: 1. How body image changes during different treatments among women treated for breast cancer? 2. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer Female, Physical Inactivity, Quality of Life
- How many people
- 300 participants
- Where
- 2 sitesHungary
- Study dates
- 1 Sep 2024to 31 Aug 2025
- Phase
- Observational
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: In the Department of Oncotherapy in the University of Pécs at the Medical School
Who may be able to join
- Adult women diagnosis of breast carcinoma
Who cannot join
- neuromuscular diseases
- severe congenital musculoskeletal and other disorders
- other surgical procedures within 1 year
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary2 sites, 2 recruiting
- Recruiting
Vörösmarty utca 4.
Pécs, Baranya, 7621
Márta Hock, physiotherapist, +3672501500 ext. 38062, hock.marta@etk.pte.hu
Márta Hock, physiotherapist
- Recruiting
Édesanyák útja 17.
Pécs, Baranya, 7624
Erika Kövér, physician, +36-72-536-480 ext. 32856, kover.erika@pte.hu
Erika Kövér, physician
About this study
Official title: Body Image and Physical Activity of Women with Breast Cancer Self-developed Questionnaire-based Follow-up Clinical Trial
The goal of this self-initiated questionnaire-based follow-up clinical trial is to map the body image and physical activity of Hungarian women treated for breast cancer.
The main questions it aims to answer are:
- How body image changes during different treatments among women treated for breast cancer?
- How is physical activity among Hungarian women treated for breast cancer?
Read the detailed description
The aim of our research is to assess the changes in physical activity and body image of women with breast cancer and the impact of these changes on their quality of life using subjective measures, through cross-sectional research and validation of the Body Image After Breast Cancer questionnaire in Hungarian.
- Conditions
- Breast Cancer Female, Physical Inactivity, Quality of Life, Body Image
- Keywords
- body image after breast cancer, physical activity, life quality
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hungarian women treated for breast cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Image After Breast Cancer
points, Body Image After Breast Cancer scale contains 53 items in the six main subscales of vulnerability (with twelve items on feelings of the susceptibility of the body to cancer), body stigma (with sixteen items on feeling to hide the body), transparency (with six items on concerns about the obviousness of cancer-related changes to appearance), body limitations (with eight items on feeling about competence and ability), body concerns (with six items on satisfaction about body shape and appearance), and arm concerns (with five items on concerns about arm symptoms and appearance). Items are scored on a five-point Likert scale from "Completely agree" to "Completely disagree" for items 1-23 and from "Never' to "Always" for items 24-53.
The higher the points, the worse the body image is.
Measured: 1 day
Global Physical Activity Questionnaire
MET-min, Global Physical Activity Questionnaire, GPAQ, 16 questions in 4 topics (assessing work, travel-related and recreational physical activity, and the time of sitting) minimum score: 0 MET-min, maximum score: 15.600 MET-min, the higher the MET-mins, the better the physical activity is.
Measured: 1 week
Secondary outcomes (5)
Patient Health Questionnaire-9
Points, the scale has 9 items, 4 point scale (not at all - nearly every day). The sum score 0-27. Scores less than 5 almost always signified the absence of a depressive disorder; scores of 5 to 9 predominantly represented patients with either no depression or subthreshold (i.e., other) depression; scores of 10 to 14 represented a spectrum of patients; and scores of 15 or greater usually indicated major depression. The higher the points, the higher the depression is.
Measured: 2 weeks
Rosenberg Self-Esteem Scale
Points, 10 items, 0-3 point scales, the sum scale ranges from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem. The higher the points, the better the self-esteem is.
Measured: 1 day
Quality of life of cancer patients or survivors (EORTC QLQ-C30)
EORTC QLQ-C30 is a 30-item instrument designed to measure quality of life in all cancer patients. All items scored 1-4 (not at all - to a great extent).
The higher the points, the worse the quality of life is.
Measured: 1 week
Quality of life of cancer patients or survivors (EORTC QLQ-BR23)
EORTC QLQ-BR23 is a 23-item instrument designed to measure quality of life in breast cancer patients. All items scored 1-4 (not at all - to a great extent).
The higher the points, the worse the quality of life is.
Measured: 4 weeks
Body Attitudes Test (BAT)
Body Attitudes Test (BAT) has 20 items, all 0-5 points scale (never - always), the sum scale has the minimum of 0, the maximum of 100. The higher the value, the worse the body attitude is.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start1 Sep 2024
- Primary completionFeb 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730815
- Sponsor's protocol ID
- 9533-PTE 2023.
- Status last verified
- Dec 2024
- First submitted
- 8 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Image and Physical Activity of Women with Breast Cancer Self-developed Questionnaire-based Follow-up Clinical Trial
- ClinicalTrials.gov ID
- NCT06730815
- Acronym / sponsor ID
- 9533-PTE 2023.
- Conditions
- Breast Cancer Female, Physical Inactivity, Quality of Life, Body Image
- Keywords
- body image after breast cancer, physical activity, life quality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this self-initiated questionnaire-based follow-up clinical trial is to map the body image and physical activity of Hungarian women treated for breast cancer.
The main questions it aims to answer are:
- How body image changes during different treatments among women treated for breast cancer?
- How is physical activity among Hungarian women treated for breast cancer?
Detailed description
The aim of our research is to assess the changes in physical activity and body image of women with breast cancer and the impact of these changes on their quality of life using subjective measures, through cross-sectional research and validation of the Body Image After Breast Cancer questionnaire in Hungarian.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hungarian women treated for breast cancer | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In the Department of Oncotherapy in the University of Pécs at the Medical School
Key inclusion criteria (1 listed)
- Adult women diagnosis of breast carcinoma
Key exclusion criteria (3 listed)
- neuromuscular diseases
- severe congenital musculoskeletal and other disorders
- other surgical procedures within 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body Image After Breast Cancer
Time frame: 1 day
points, Body Image After Breast Cancer scale contains 53 items in the six main subscales of vulnerability (with twelve items on feelings of the susceptibility of the body to cancer), body stigma (with sixteen items on feeling to hide the body), transparency (with six items on concerns about the obviousness of cancer-related changes to appearance), body limitations (with eight items on feeling about competence and ability), body concerns (with six items on satisfaction about body shape and appearance), and arm concerns (with five items on concerns about arm symptoms and appearance). Items are scored on a five-point Likert scale from "Completely agree" to "Completely disagree" for items 1-23 and from "Never' to "Always" for items 24-53. The higher the points, the worse the body image is.
Global Physical Activity Questionnaire
Time frame: 1 week
MET-min, Global Physical Activity Questionnaire, GPAQ, 16 questions in 4 topics (assessing work, travel-related and recreational physical activity, and the time of sitting) minimum score: 0 MET-min, maximum score: 15.600 MET-min, the higher the MET-mins, the better the physical activity is.
5 secondary outcomes
Patient Health Questionnaire-9
Time frame: 2 weeks
Rosenberg Self-Esteem Scale
Time frame: 1 day
Quality of life of cancer patients or survivors (EORTC QLQ-C30)
Time frame: 1 week
Quality of life of cancer patients or survivors (EORTC QLQ-BR23)
Time frame: 4 weeks
Body Attitudes Test (BAT)
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female and Physical Inactivity, run by University of Pecs at 2 sites in Hungary.
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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary. 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?
Contact Márta Hock, physiotherapist (+3672501500 ext. 38062, hock.marta@etk.pte.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Image After Breast Cancer (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2024.