Kinesiophobia in Prostate Cancer

January 26, 2024 updated by: Emine Cihan, Selcuk University

Physical Activity, Fear of Falling, Fatigue and Functionality in Prostate Cancer

This study aimed to investigate the effects of prostate cancer on patients' physical activity, kinesiophobia, fatigue and functionality.

This research is a prospective study to be conducted on volunteer individuals between the ages of 40-75. People diagnosed with prostate cancer (study group) and healthy adults who have not been diagnosed with prostate cancer before (control group) will be included in the study. The demographic characteristics, physical activity levels and quality of life of all individuals participating in the study will be evaluated with an online form. In demographic data, physical, sociodemographic data such as age (years), height (cm), body weight (kg), body mass index (kg/m2) and disease-specific information will be recorded. Physical activity level will be measured with the International Physical Activity Survey short form (UFAA), fatigue with the Functional Evaluation of Chronic Disease Treatment-Fatigue Questionnaire, fear of movement with the Causes of Fear of Movement Questionnaire, and quality of life with the Functional Evaluation of Cancer Treatment-Prostate Version questionnaire (KHTFD-Y).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Turkey
    • Selcuklu
      • Konya, Selcuklu, Turkey, 42130
        • Selcuk University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Study Population

Male patients diagnosed with prostate cancer and healthy men with similar demographic characteristics

Description

Inclusion Criteria:

  • (for prostate cancer-study group)

    • Being between the ages of 40-75
    • Want to participate in the study
    • Being able to read and write
    • Being diagnosed with prostate cancer by a specialist physician,
    • Being able to provide their mobility independently,

  • (for healthy controls - control group)

    • Being between the ages of 40-75
    • Not having any previous cancer history and not having undergone cancer surgery
    • Volunteering to participate in the study

Exclusion Criteria:

  • Those with a previously known or accompanying diagnosis of dementia
  • Not wanting to participate in the study
  • The individual has a disease that may prevent him or her from understanding and completing the survey.
  • Illiterates
  • Those who do not want to participate in the research voluntarily
  • Having active metastasis
  • Having undergone chemotherapy and radiotherapy in the last 6 months

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

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
Other: survey evaluation
assessment of physical activity, fatigue, fear of movement, and quality of life
Experimental: prostate group
Other: survey evaluation
assessment of physical activity, fatigue, fear of movement, and quality of life

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Physical Activity Survey short form
Time Frame: 10 minutes
The short form consists of 7 questions. The form provides information about the frequency and time spent in walking, moderate physical activity, and vigorous physical activity.
10 minutes
Functional Assessment of Fatigue Chronic Disease Treatment-Fatigue Questionnaire
Time Frame: 10 minutes
It consists of 13 questions that evaluate the level of fatigue that occurred during daily activities in the last 7 days. Scoring varies between 0-52. High scores indicate less fatigue.
10 minutes
Reasons for Fear of Movement Questionnaire
Time Frame: 10 minutes
It allows the causes of kinesiophobia to be identified and both biological and psychological causes to be determined separately. The average of the scores obtained from the biological and physiological subscales gives the total score from the survey. A 5-point Likert scoring (1 = Totally disagree, 5 = Completely agree) is used in the scale. An individual's high score from the survey indicates that he/she has more fear of movement.
10 minutes
Functional Evaluation of Cancer Treatment-Prostate Version questionnaire
Time Frame: 10 minutes
It consists of 13 questions that evaluate the level of fatigue that occurred during daily activities in the last 7 days. Scoring varies between 0-52. High scores indicate less fatigue.
10 minutes

Collaborators and Investigators

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

Sponsor

Selcuk 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)

November 9, 2023

Primary Completion (Actual)

November 20, 2023

Study Completion (Actual)

December 4, 2023

Study Registration Dates

First Submitted

November 9, 2023

First Submitted That Met QC Criteria

November 9, 2023

First Posted (Actual)

November 14, 2023

Study Record Updates

Last Update Posted (Actual)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 26, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/11.09

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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