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Clinical Trials/NCT05090098
NCT05090098
Completed
Not Applicable

Comparison of the Effects of Fear of Movement and Physical Activity Barriers on Physical Activity, Quality of Life and Psychological State of Women Who Have Had or Are Having Breast Cancer With Healthy People - Case Control Study

Acibadem University1 site in 1 country180 target enrollmentAugust 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Acibadem University
Enrollment
180
Locations
1
Primary Endpoint
Questionnaire on exercise barriers
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Breast cancer is the most common type of cancer in women worldwide. A significant number of breast cancer survivors develop many complications. Breast cancer and survivors may develop a fear of physical activity avoidance and movement, called kinesiophobia, due to upper extremity pain, numbness, restricted arm/shoulder range of motion, and risk of lymphedema. Therefore, in the present study, it is aimed to compare the effect of fear of movement on physical activity, quality of life and psychological states in women who have had breast cancer with healthy people.

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
May 15, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Acibadem University
Responsible Party
Principal Investigator
Principal Investigator

Nuray Alaca

Assoc Prof. Nuray Alaca

Acibadem University

Eligibility Criteria

Inclusion Criteria

  • • Women diagnosed with stage I-II-III breast cancer with surgery as the first treatment
  • The patient whose first treatment was completed at least three months ago (surgery, radiotherapy and / or chemotherapy)
  • 18-75 years old woman
  • Does not have a Turkish literacy problem

Exclusion Criteria

  • • A serious chronic disease (rheumatoid arthritis, multiple sclerosis, amyotrophic lateral sclerosis, kidney disease, heart failure, neurological disorders or diabetes mellitus type I or II patients)
  • Having severe musculoskeletal pain or disease
  • Serious psychiatric illness
  • Patients with current cancer attack or metastasis
  • Persons with cognitive impairment

Outcomes

Primary Outcomes

Questionnaire on exercise barriers

Time Frame: Six month

This questionnaire contains a total of 35 obstacles. These obstacles are; symptom-related (n = 10), individual (n = 10), psychosocial (n = 8) and environmental (n = 7) factors. You will be asked if these obstacles prevent you from exercising.

INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRES (IPAQ)

Time Frame: Six month

Physical activity level measured in Metabolic Equivalent

Tampa Kinesiophobia Scale

Time Frame: Six month

The TAMPA Kinesiophobia Scale consists of 17 questions. Each question is scored between 1-4. The maximum score is 68, with high scores indicating an increased severity of kinesiophobia. A score of more than 37 indicates high severity of kinesiophobia.

Secondary Outcomes

  • Fatigue Severity Scale(Six month)
  • Hospital Anxiety and Depression Scale(Six month)
  • Evaluation of Quality of Life: EORTC-Quality of Life -C 30(Six month)

Study Sites (1)

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