Body Image and Physical Activity of Women with Breast Cancer

NCT06730815 | Recruiting DMC

• 1 other identifier: 9533-PTE 2023.
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief 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. 1.How body image changes during different treatments among women treated for breast cancer?
2. 2.How is physical activity among Hungarian women treated for breast cancer?

Conditions

Breast Cancer Female; Physical Inactivity; Quality of Life; Body Image

Keywords

body image after breast cancer; physical activity; life quality

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Patient Health Questionnaire-9

  2 weeks

• Rosenberg Self-Esteem Scale

  1 day

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

  1 week

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

  4 weeks

• Body Attitudes Test (BAT)

  1 day

Study Arms (1)

Hungarian women treated for breast cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Adult women diagnosis of breast carcinoma

You may not qualify if:

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

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (2)

Vörösmarty utca 4.

Pécs, Baranya, 7621, Hungary

RECRUITING

Édesanyák útja 17.

Pécs, Baranya, 7624, Hungary

RECRUITING

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Márta Hock, physiotherapist

CONTACT

+3672501500; hock.marta@etk.pte.hu

Zsuzsanna Poto, economist

CONTACT

+36205019991; zsuzsanna.poto@etk.pte.hu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 12, 2024
• Study Start: September 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: August 31, 2025
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

HU (2)