The Relationships Between Physical Activity Level, Quality of Life and Cognitive Level in Breast Cancer Patients

Quality of Life Clinical Trial

Official title:

Investigation of the Relationships Between Physical Activity Level, Quality of Life and Cognitive Level in Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05275517
• Other study ID #: Iboelif22
• Status: Completed
• Start date: January 5, 2022
• Est. completion date: September 5, 2022

Study information

• Verified date: May 2023
• Source: Aydin Adnan Menderes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to determine the relationships between physical activity level, quality of life and cognitive level in patients with breast cancer and to compare the results with a population of similar age group.

Description:

This study is a cross-sectional, analytical type study and will be conducted with chemotherapy patients diagnosed with breast cancer and treated in Aydın Adnan Menderes University Faculty of Medicine Research and Practice Hospital, Department of Oncology. Patients diagnosed with breast cancer and undergoing chemotherapy will be provided by the researcher to fill out the questionnaires.

Healthy peers will also form the control group. First of all, mini mental test will be applied to all participants and those who get at least 24 points from the test will be included in the study. International Survey of Physical Activity (IPAQ),EORTC QLQC30 Quality of Life Scale,Montreal Cognitive Assessment Scale (MOCA) will be administered to all participants face to face by the researcher.

The hypotheses the investigators will test for this purpors; H0; There is no relationship between physical activity level, quality of life and cognitive level in patients with breast cancer.

H1a: Physical activity level of patients with breast cancer affects their quality of life.

H1b: Physical activity level affects cognitive level in patients with breast cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 5, 2022
• Est. primary completion date: August 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Being treated at Aydin Adnan Menderes University Faculty of Medicine Research and Application Hospital

• Being diagnosed with cancer at least 3 months before the study and receiving chemotherapy treatment

• Mini mental test result of at least 24

• To be conscious,

• Be over the age of 18,

• Being diagnosed with mass-style cancer,

• Patients with walking function

In the Healthy Control group:

• Over 18 years

• Never been diagnosed and treated for cancer before

• Volunteers who do not have a disease that will impair cognitive functions

Exclusion Criteria:

• Patients with brain metastases

• Patients with cognitive and psychiatric problems

• Patients with a diagnosis of hematological type cancer

• Patients receiving palliative care will not be included in the study. For the healthy control group

• With systemic disease

• Have a chronic illness

• Having problems that interfere with physical activity

Related Conditions & MeSH terms

• Chemotherapy
• Patient
• Physical Activity
• Quality of Life

Locations

Country	Name	City	State
Turkey	Aydin Adnan Menderes University Hospital	Aydin

Sponsors (1)

Lead Sponsor	Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographic Information Form	In the form prepared by the researchers with the support of the literature, there are questions about the sociodemographic characteristics of the participants such as gender, age, height, weight, educational status,etc.	1 year
Primary	Mini Mental State Test	It is a scale used to evaluate the cognitive status of individuals. Test; It evaluates verbal responses including attention, orientation and memory, ability to obey verbal and written orders, write spontaneous sentences, and copy a complex drawing. The cut-off value of this scale, which consists of a total of 30 points, is 24 points. Values below 24 indicate deterioration in cognitive status.	1 year
Primary	International Survey of Physical Activity (IPAQ)	This form will be used to determine the duration of physical activity that patients have done in the last 7 days. The 27-question survey evaluates in detail the amount of walking done in the past week and the amount of moderate to vigorous physical activity done at work, transportation, housework, gardening and leisure activities.	1 year
Primary	EORTC QLQC30 Quality of Life Scale	This questionnaire is used to determine their quality of life. It includes 30 questions and three subheadings: general well-being, functional difficulties and symptom control. The first 28 of the 30 items in the scale are a four-point Likert-type scale and the items are evaluated as Never: 1, A little: 2, Quite: 3 or A lot: 4 points.	1 year
Primary	Montreal Cognitive Assessment Scale (MOCA)	This test assesses different cognitive functions including attention and concentration, executive functions, language, memory, visual construction skills, abstract thinking, calculation and orientation. The highest score that can be obtained from the test is 30. Cognitive status levels of individuals with a score of 21 and above are considered normal.	1 year