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NCT Number: NCT06730815

Body Image and Physical Activity of Women with Breast Cancer

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. How is physical activity among Hungarian women treated for breast cancer?

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Vörösmarty utca 4., Pécs, Baranya, Hungary

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult women diagnosis of breast carcinoma

Exclusion criteria

  • neuromuscular diseases
  • severe congenital musculoskeletal and other disorders
  • other surgical procedures within 1 year

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Patient Health Questionnaire-9

    Time frame: 2 weeks

    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.

  2. Rosenberg Self-Esteem Scale

    Time frame: 1 day

    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.

  3. Quality of life of cancer patients or survivors (EORTC QLQ-C30)

    Time frame: 1 week

    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.

  4. Quality of life of cancer patients or survivors (EORTC QLQ-BR23)

    Time frame: 4 weeks

    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.

  5. Body Attitudes Test (BAT)

    Time frame: 1 day

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Márta Hock, physiotherapist

CONTACT

[email protected]

+3672501500 ext. 38062

Zsuzsanna Poto, economist

CONTACT

[email protected]

+36205019991

Sponsors and collaborators

Lead sponsor

University of Pecs

Other

Registry information

Official study title

Body Image and Physical Activity of Women with Breast Cancer Self-developed Questionnaire-based Follow-up Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 12, 2024
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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