Clinical trial NCT05090098: Breast Cancer and Kinesiophobia and Physical Activity
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Kinesiophobia
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Tampa Kinesiophobia Scale
timeFrame: Six month
measure: Questionnaire on exercise barriers
timeFrame: Six month
measure: INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRES (IPAQ)
timeFrame: Six month
Secondary outcomes:
measure: Fatigue Severity Scale
timeFrame: Six month
measure: Hospital Anxiety and Depression Scale
timeFrame: Six month
measure: Evaluation of Quality of Life: EORTC-Quality of Life -C 30
timeFrame: Six month
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Acıbadem University
Study officials:
References: