Body Image and Physical Activity of Women with Breast Cancer

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:

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?

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Body Image; Breast Cancer Female; Physical Inactivity

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Márta Hock, physiotherapist; Phone Number: 38062 +3672501500; Email: hock.marta@etk.pte.hu
• Study Contact Backup: Name: Zsuzsanna Poto, economist; Phone Number: +36205019991; Email: zsuzsanna.poto@etk.pte.hu

Study Locations

• Hungary
  • Baranya
    • Pécs, Baranya, Hungary, 7621
      • Recruiting
      • Vörösmarty utca 4.
      • Contact: Márta Hock, physiotherapist; Phone Number: 38062 +3672501500; Email: hock.marta@etk.pte.hu
      • Contact: Márta Hock, physiotherapist
    • Pécs, Baranya, Hungary, 7624
      • Recruiting
      • Édesanyák útja 17.
      • Contact: Erika Kövér, physician; Phone Number: 32856 +36-72-536-480; Email: kover.erika@pte.hu
      • Contact: Erika Kövér, physician

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

In the Department of Oncotherapy in the University of Pécs at the Medical School

Description

Inclusion Criteria:

• Adult women diagnosis of breast carcinoma

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Hungarian women treated for breast cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	1 day

Collaborators and Investigators

• Sponsor: University of Pecs

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: December 8, 2024
• First Submitted That Met QC Criteria: December 8, 2024
• First Posted (Actual): December 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: physical activity; life quality; body image after breast cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 9533-PTE 2023.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No