Prostate CancerNCT06131853
Kinesiophobia in Prostate Cancer
A study testing survey evaluation in people with Prostate Cancer and Kinesiophobia, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Kinesiophobia, Physical Inactivity
- What is being tested?
- survey evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Nov 2023to 4 Dec 2023
- Phase
- Interventional
- 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 40 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (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,
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- (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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Prostate Cancer, Kinesiophobia, Physical Inactivity
- Being tested
- survey evaluation
- Medical subject headings
- Prostatic Neoplasms, Kinesiophobia, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
survey evaluationOther
assessment of physical activity, fatigue, fear of movement, and quality of life
| Study group | Role | What they receive |
|---|---|---|
| prostate group | Experimental | Not described Receives: Other: survey evaluation |
| control group | Active comparator | Not described Receives: Other: survey evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start9 Nov 2023
- Primary completion20 Nov 2023
- Study completion4 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Cihan, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131853
- Sponsor's protocol ID
- 2023/11.09
- Status last verified
- Jan 2024
- First submitted
- 9 Nov 2023
- Last updated
- 29 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity, Fear of Falling, Fatigue and Functionality in Prostate Cancer
- ClinicalTrials.gov ID
- NCT06131853
- Acronym / sponsor ID
- 2023/11.09
- Conditions
- Prostate Cancer, Kinesiophobia, Physical Inactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 14 Nov 2023 (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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prostate group | Experimental | Other: survey evaluation |
| control group | Active comparator | Other: survey evaluation |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- (for prostate cancer-study group)
- (for healthy controls - control group)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| survey evaluationassessment of physical activity, fatigue, fear of movement, and quality of life | Other | control group, prostate group |
Primary outcome
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.
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.
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.
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.
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 29 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing survey evaluation in people with Prostate Cancer and Kinesiophobia, run by Selcuk 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 10 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 29 Jan 2024. 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?
International Physical Activity Survey short form (time frame: 10 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2024.