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

May 9, 2023 updated by: Nazan Ozturk, Aydin Adnan Menderes University

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

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Esin Oktay, Assoc.Prof.
  • Phone Number: 05053170639
  • Email: esinct@gmail.com

Study Contact Backup

Study Locations

  • Turkey
      • Aydin, Turkey
        • Aydın Adnan Menderes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients receiving chemotherapy with the diagnosis of breast cancer in the Oncology Department of Aydin Adnan Menderes University Research and Practice Hospital

Description

Inclusion Criteria:

  • Being treated at Aydın 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic Information Form
Time Frame: 1 year
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
Mini Mental State Test
Time Frame: 1 year
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
International Survey of Physical Activity (IPAQ)
Time Frame: 1 year
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
EORTC QLQC30 Quality of Life Scale
Time Frame: 1 year
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
Montreal Cognitive Assessment Scale (MOCA)
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aydin Adnan Menderes University

Investigators

  • Principal Investigator: Nazan Ozturk, PhD., Aydin Adnan Menderes University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2022

Primary Completion (Actual)

August 5, 2022

Study Completion (Actual)

September 5, 2022

Study Registration Dates

First Submitted

February 10, 2022

First Submitted That Met QC Criteria

March 2, 2022

First Posted (Actual)

March 11, 2022

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • İboelif22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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