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

Sponsor
Aydin Adnan Menderes University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05275517
Collaborator
(none)
54
1
8
6.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    54 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Investigation of the Relationships Between Physical Activity Level, Quality of Life and Cognitive Level in Breast Cancer Patients
    Actual Study Start Date :
    Jan 5, 2022
    Anticipated Primary Completion Date :
    Aug 5, 2022
    Anticipated Study Completion Date :
    Sep 5, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Demographic Information Form [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.

    2. Mini Mental State Test [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.

    3. International Survey of Physical Activity (IPAQ) [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.

    4. EORTC QLQC30 Quality of Life Scale [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.

    5. Montreal Cognitive Assessment Scale (MOCA) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aydın Adnan Menderes University Hospital Aydin Turkey

    Sponsors and Collaborators

    • Aydin Adnan Menderes University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nazan Ozturk, Principal Investigator, Aydin Adnan Menderes University
    ClinicalTrials.gov Identifier:
    NCT05275517
    Other Study ID Numbers:
    • İboelif22
    First Posted:
    Mar 11, 2022
    Last Update Posted:
    Jul 13, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nazan Ozturk, Principal Investigator, Aydin Adnan Menderes University

    Study Results

    No Results Posted as of Jul 13, 2022