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NCT Number: NCT05090098

Breast Cancer and Kinesiophobia and Physical Activity

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.

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Key information

Conditions

Breast Cancer Anxiety Disorders Breast Diseases Breast Neoplasms Kinesiophobia Mental Disorders Neoplasms Neoplasms by Site Phobic Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Acıbadem University

Istanbul, +90, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

None intervention

Other

None intervention

Primary outcomes

  1. 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.

  2. 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.

  3. INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRES (IPAQ)

    Time frame: Six month

    Physical activity level measured in Metabolic Equivalent

Secondary outcomes

  1. Fatigue Severity Scale

    Time frame: Six month

    This scale consists of nine items. Each item is scored between 1 and 7, and as the total score decreases, fatigue decreases.

  2. Hospital Anxiety and Depression Scale

    Time frame: Six month

    The lowest score that patients can get from both subscales is 0, and the highest score is 21. A high score indicates high anxiety and depression values.

  3. Evaluation of Quality of Life: EORTC-Quality of Life -C 30

    Time frame: Six month

    High scores indicate a high quality of life, and low scores indicate a decreased quality of life.

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Oct 22, 2021
Registry last updated
Jun 1, 2022

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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