NCT05275517

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2022

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

7 months

First QC Date

February 10, 2022

Last Update Submit

May 9, 2023

Conditions

Keywords

Physical ActivityQuality of LifeChemotherapyCognitive level

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydın Adnan Menderes University Hospital

Aydin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Nazan Ozturk, PhD.

    Aydin Adnan Menderes University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 10, 2022

First Posted

March 11, 2022

Study Start

January 5, 2022

Primary Completion

August 5, 2022

Study Completion

September 5, 2022

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations