Breast Cancer and Kinesiophobia and Physical Activity

Completed

• Conditions: Breast Cancer; Kinesiophobia
• Interventions: Other: None intervention

• Registration Number: NCT05090098
• Lead Sponsor: Acibadem University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2021-10-11
• Study First Submitted QC: 2021-10-11
• Study First Posted: 2021-10-22
• Primary Completion: 2021-11-15
• Status Verified: 2022-05
• Study Completion: 2022-05-15
• Last Update Submitted: 2022-05-30
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast cancer survivors	None intervention	Sixty patients with grade I-II-III breast cancer, whose primary treatment (surgery, radiotherapy and/or chemotherapy) was completed at least three months ago, who applied to the Hospital Breast Unit clinic, will be included in the study. Patients with problems in reading and writing in Turkish, poor cognitive functions and a serious chronic disease, musculoskeletal pain or disease, severe psychiatric illness, current cancer attack or metastasis will be excluded from the study
Healthy people	None intervention	healthy individuals matched for age and gender will also be included in the study.
Breast cancer	None intervention	Sixty patients with grade I-II-III breast cancer, whose primary treatment (surgery, radiotherapy and/or chemotherapy) is continuing, who applied to the Hospital Breast Unit clinic, will be included in the study. Patients with problems in reading and writing in Turkish, poor cognitive functions and a serious chronic disease, musculoskeletal pain or disease, severe psychiatric illness, current cancer attack or metastasis will be excluded from the study

Primary Outcome Measures

Name	Time	Method
Questionnaire on exercise barriers	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)	Six month	Physical activity level measured in Metabolic Equivalent
Tampa Kinesiophobia Scale	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 Outcome Measures

Name	Time	Method
Fatigue Severity Scale	Six month	This scale consists of nine items. Each item is scored between 1 and 7, and as the total score decreases, fatigue decreases.
Hospital Anxiety and Depression Scale	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.
Evaluation of Quality of Life: EORTC-Quality of Life -C 30	Six month	High scores indicate a high quality of life, and low scores indicate a decreased quality of life.

Trial Locations

Locations (1)

Acıbadem University; 🇹🇷 İstanbul, Turkey