Breast Cancer and Kinesiophobia and Physical Activity

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Kinesiophobia
• Intervention / Treatment: Other: None intervention

• Study Type: Observational
• Enrollment (Actual): 180

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey, +90
    • Acıbadem University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; None intervention
Healthy people; healthy individuals matched for age and gender will also be included in the study.	Other: None intervention; None intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Acibadem University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2021
• Primary Completion (ACTUAL): November 15, 2021
• Study Completion (ACTUAL): May 15, 2022

Study Registration Dates

• First Submitted: October 11, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (ACTUAL): October 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ATADEK-2021/14/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No