Breast Cancer and Kinesiophobia and Physical Activity

Breast Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05090098
• Other study ID #: ATADEK-2021/14/16
• Status: Completed
• Start date: August 1, 2021
• Est. completion date: May 15, 2022

Study information

• Verified date: May 2022
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: May 15, 2022
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Kinesiophobia

Intervention

Other:
• None intervention
None intervention

Locations

Country	Name	City	State
Turkey	Acibadem University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tampa Kinesiophobia Scale	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.	Six month
Primary	Questionnaire on exercise barriers	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.	Six month
Primary	INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRES (IPAQ)	Physical activity level measured in Metabolic Equivalent	Six month
Secondary	Fatigue Severity Scale	This scale consists of nine items. Each item is scored between 1 and 7, and as the total score decreases, fatigue decreases.	Six month
Secondary	Hospital Anxiety and Depression Scale	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.	Six month
Secondary	Evaluation of Quality of Life: EORTC-Quality of Life -C 30	High scores indicate a high quality of life, and low scores indicate a decreased quality of life.	Six month