Physical ActivityNCT05275517

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

An observational study of Physical Activity and Patient, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Physical Activity, Patient, Quality of Life
How many people: 54 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 5 Jan 2022to 5 Sep 2022
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

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

Who may be able to join

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,

Show all 11Show fewer

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Aydın Adnan Menderes University Hospital
Aydin

Other trials in Turkey (Türkiye)

About this study

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

Read the 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.

Conditions: Physical Activity, Patient, Quality of Life, Chemotherapy
Keywords: Physical Activity, Quality of Life, Chemotherapy, Cognitive level
Medical subject headings: Motor Activity

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jan 20225 Sep 2022

First posted11 Mar 2022
Study start5 Jan 2022
Primary completion5 Aug 2022
Study completion5 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Physical ActivityStudies of the same condition, open and under way.
More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05275517
Sponsor's protocol ID: İboelif22
Status last verified: May 2023
First submitted: 10 Feb 2022
Last updated: 10 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Physical Activity trials

Study at a glance

From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of the Relationships Between Physical Activity Level, Quality of Life and Cognitive Level in Breast Cancer Patients
ClinicalTrials.gov ID: NCT05275517
Acronym / sponsor ID: İboelif22
Conditions: Physical Activity, Patient, Quality of Life, Chemotherapy
Keywords: Physical Activity, Quality of Life, Chemotherapy, Cognitive level
Study type: Observational
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Aydin Adnan Menderes UniversityUniversity, hospital or other
Study start: 5 Jan 2022 (actual)
Primary completion: 5 Aug 2022 (actual)
Study completion: 5 Sep 2022 (actual)
First posted: 11 Mar 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Observational model: Case-control
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Patients receiving chemotherapy with the diagnosis of breast cancer in the Oncology Department of Aydin Adnan Menderes University Research and Practice Hospital

Key inclusion criteria (11 listed)

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,

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.
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.
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.
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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.

Related trials for Physical Activity

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nazan Ozturk, PhD. principal investigator

Aydin Adnan Menderes University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Physical Activity and Patient, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Demographic Information Form (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05275517.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.