NCT06131853

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable prostate-cancer

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

First Submitted

Initial submission to the registry

November 9, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

November 9, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2023

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2023

Completed
Last Updated

January 29, 2024

Status Verified

January 1, 2024

Enrollment Period

11 days

First QC Date

November 9, 2023

Last Update Submit

January 26, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • International Physical Activity Survey short form

    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

    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

    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

    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

Study Arms (2)

prostate group

EXPERIMENTAL
Other: survey evaluation

control group

ACTIVE COMPARATOR
Other: survey evaluation

Interventions

assessment of physical activity, fatigue, fear of movement, and quality of life

control groupprostate group

Eligibility Criteria

Age40 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University

Konya, Selcuklu, 42130, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prostatic NeoplasmsKinesiophobiaSedentary Behavior

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesPhobic DisordersAnxiety DisordersMental DisordersBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst Prof Dr

Study Record Dates

First Submitted

November 9, 2023

First Posted

November 14, 2023

Study Start

November 9, 2023

Primary Completion

November 20, 2023

Study Completion

December 4, 2023

Last Updated

January 29, 2024

Record last verified: 2024-01

Locations