Breast Cancer and Kinesiophobia and Physical Activity

NCT05090098 | Completed

• 1 other identifier: ATADEK-2021/14/16
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Kinesiophobia

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRES (IPAQ)

  Physical activity level measured in Metabolic Equivalent

  Six month

Secondary Outcomes (3)

• 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 Arms (3)

Breast cancer

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

Other: None intervention

Breast cancer survivors

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

Other: None intervention

Healthy people

healthy individuals matched for age and gender will also be included in the study.

Other: None intervention

Interventions

None intervention OTHER

None intervention

Breast cancer; Breast cancer survivors; Healthy people

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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 Acıbadem Maslak 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 \[17\]. Since it is a case-control study, 60 healthy individuals matched for age and gender will also be included in the study.

You may qualify if:

• 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)
• years old woman
• Does not have a Turkish literacy problem

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acıbadem University

Istanbul, +90, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms; Kinesiophobia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof. Nuray Alaca

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 22, 2021
• Study Start: August 1, 2021
• Primary Completion: November 15, 2021
• Study Completion: May 15, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Locations

TU (1)