AnxietySCREENNCT07800390
proState Cancer Health Education to pRomote Early sreENing Uptake (SCREEN): A Pilot Randomised Control Trial
A study testing proState Cancer awareness education to pRomote Early screENing uptake in people with Anxiety and Prostate Cancer, run by Teesside University.
Trial summary
Prostate cancer is an issue of significant public health concern. Yet in low- and middle-income countries like Nigeria, men are adversely affected due to factors including poor early prostate cancer screening uptake. Yet a gap remains in addressing this urgent problem. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Prostate Cancer, Health Education
- What is being tested?
- proState Cancer awareness education to pRomote Early screENing uptake
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men aged between age 18 years and 79 who are not or partially up to date with prostate cancer
- Able to provide full consent for their participation.
- Able to speak the English Language. Able to take part in the intervention and are available for the intervention assessment at baseline and end of intervention.
Who cannot join
- Less than 18 years
- Unable to consent.
- Currently undergoing severe mental health treatment.
- Unable to speak the English language
- not meeting the inclusion criteria.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Dung E Jidong, PhD contact
About this study
Prostate cancer is an issue of significant public health concern. Yet in low- and middle-income countries like Nigeria, men are adversely affected due to factors including poor early prostate cancer screening uptake. Yet a gap remains in addressing this urgent problem. The proposed study seeks to pilot the feasibility and acceptability of a novel co-produced workshop intervention called "proState Cancer awareness education to pRomote Early screENing uptake (SCREEN) with men who are not or partially up to date with their screening. The SCREEN intervention is designed to raise awareness of prostate cancer, its symptoms, implications for late screening, the benefits of early screening, avenues for screening uptake, and also addressing anxiety related to screening uptake. The SCREEN intervention is low-intensity and lasts approximately two hours. The proposed study also aims to pilot and test the instrument to determine its effectiveness and cost-effectiveness, including the mechanism by which the intervention might work.
- Conditions
- Anxiety, Prostate Cancer, Health Education, Screening and Brief Interventions, Screening, Wellbeing
- Being tested
- proState Cancer awareness education to pRomote Early screENing uptake, Control group
- Keywords
- Prostate cancer screening, Health education workshop, anxiety, Early screening uptake
- Medical subject headings
- Anxiety Disorders, Prostatic Neoplasms, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proState Cancer awareness education to pRomote Early screENing uptakeBehavioural
The SCREEN intervention is designed to raise awareness of prostate cancer, its symptoms, implications for late screening, the benefits of early screening, avenues for screening uptake, and also addressing anxiety related to screening uptake. The SCREEN intervention is low-intensity and lasts approximately two hours.
Control groupOther
Existing information provided by health care provider, including media around prostate cancer.
| Study group | Role | What they receive |
|---|---|---|
| proState Cancer awareness education to pRomote Early screENing uptake (SCREEN) | Experimental | 2 hour worksop session to foster awareness and encourage screening uptake Receives: Behavioral: proState Cancer awareness education to pRomote Early screENing uptake |
| Control group | Active comparator | The control group will receive intervention as usual. This may be in the form of existing prostate cancer screening information provided in hospitals, media and health centres. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Service Satisfaction Scale
A five item scale that can be used to assess and measure satisfaction, acceptability and quality of the intervention. Higher score denote positive outcomes and acceptability. Lower score denotes poor satisfaction and acceptability.
Measured: At the end of intervention (day 2)
Secondary outcomes (6)
Generalised Anxiety Disorder (GAD-7)
The GAD-7 is a seven item scale for screening, measuring and assessing the severity of generalised anxiety disorder. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Measured: Baseline (day 1) and at the end of intervention (day 2)]
Oslo Social Support Scale (OSSS-3)
The scale is a 3-item self-reported measure designed for assessing and measuring the level of social support. The sum score ranges from 3 to 14, with high values representing strong levels and low values representing poor levels of social support as indicated as follows: a) 3-8 poor social support, b) 9-11 moderate social support, c) 12-14 strong social support.
Measured: Baseline (day 1) and at the end of intervention (day 2)
European Quality of Life Scale EQ-5D-5L
The EQ-5D-5L is a 5 item scale designed to aid assessment of the generic quality of life. In the EQ-5D-5L, each dimension has five response levels: no problems (Level 1); slight (Level 2); moderate (Level 3); severe (Level 4); and extreme problems (Level 5). There are 3,125 possible health states defined by combining one level from each dimension, ranging from 11111 (full health) to 55555 (worst health).
Measured: Baseline (day 1) and at the end of intervention (day 2)
Knowledge of prostate cancer and screening scale
14 item scale that measures knowledge of Prostate Cancer (PC). The 14 items on the PC knowledge scale is scored according to whether or not the participants responded correctly to each question, and the total number of correct responses will be calculated ranging from 0 to 14, with higher scores indicating higher PC knowledge.
Measured: Baseline (day 1) and at the end of intervention (day 2)]
Beliefs around prostate cancer and screening intention scale
A 5-item scale that measure beliefs around prostate cancer and intention to engage in screening. Score range from 0-25 with lower score denoting strong willingness to engage in early screening uptake.
Measured: Baseline (day 1) and at the end of intervention (day 2)
Intention to test for prostate cancer scale
The scale assesses the intention to take a PSA test among men when this test is: (i) offered by a doctor or (ii) based on the men's own initiative. It also predicts which attitudes (beliefs, outcomes), subjective norms (opinions of significant others, own motivation) and perceived control (obstacles, facilitating factors) are the most important for taking a PSA test. Lower total scores mean a stronger and more determined intention to undergo prostate cancer screening. Higher scores indicate low or absent readiness to complete the test.
Measured: Baseline (day 1) and at the end of intervention (day 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teesside University
- Sponsor type
- University, hospital or other
- Collaborators
- Jos University Teaching Hospital, University of Manchester
- Responsible party
- Principal investigator, Tarela Ike, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800390
- Sponsor's protocol ID
- 0000-0003-0516-0313k
- Acronym
- SCREEN
- Status last verified
- Aug 2026
- First submitted
- 29 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data supporting this study cannot be made available due to the sensitive nature and ethical reasons on confidentiality.
Publications
Rawla P. Epidemiology of Prostate Cancer. World J Oncol. 2019 Apr;10(2):63-89. doi: 10.14740/wjon1191. Epub 2019 Apr 20.
PubMed 31068988Dozie INS, Chukwuocha UM, Innocent DC, Dozie UW, Chukwuemeka PS. A systematic review and meta-analysis of the prevalence and risk factors of prostate cancer in Nigeria. BMC Cancer. 2025 Nov 26;25(1):1932. doi: 10.1186/s12885-025-15358-4.
PubMed 41299322Abdus-Salam AA, Jimoh MA, Folasire AM, Ntekim AI, Ojo OT, Ehiedu CG, Yusuf SA, Takure AO, Akinlade BI, Idowu OK, Oladeji AA, Sarimiye FO, Adenipekun AA. Sociodemographic and clinicopathologic characteristics of patients treated with high dose rate prostate brachytherapy in Nigeria. Ecancermedicalscience. 2024 Aug 14;18:1740. doi: 10.3332/ecancer.2024.1740. eCollection 2024.
PubMed 39421165
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- proState Cancer Health Education to pRomote Early sreENing Uptake (SCREEN): A Pilot Randomised Control Trial
- ClinicalTrials.gov ID
- NCT07800390
- Acronym / sponsor ID
- SCREEN / 0000-0003-0516-0313k
- Conditions
- Anxiety, Prostate Cancer, Health Education, Screening and Brief Interventions, Screening, Wellbeing
- Keywords
- Prostate cancer screening, Health education workshop, anxiety, Early screening uptake
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Teesside UniversityUniversity, hospital or other
- Collaborators
- Jos University Teaching Hospital, University of Manchester
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 2 Sep 2026 (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.
Prostate cancer is an issue of significant public health concern. Yet in low- and middle-income countries like Nigeria, men are adversely affected due to factors including poor early prostate cancer screening uptake. Yet a gap remains in addressing this urgent problem. The proposed study seeks to pilot the feasibility and acceptability of a novel co-produced workshop intervention called "proState Cancer awareness education to pRomote Early screENing uptake (SCREEN) with men who are not or partially up to date with their screening. The SCREEN intervention is designed to raise awareness of prostate cancer, its symptoms, implications for late screening, the benefits of early screening, avenues for screening uptake, and also addressing anxiety related to screening uptake. The SCREEN intervention is low-intensity and lasts approximately two hours. The proposed study also aims to pilot and test the instrument to determine its effectiveness and cost-effectiveness, including the mechanism by which the intervention might work.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| proState Cancer awareness education to pRomote Early screENing uptake (SCREEN) | Experimental | Behavioral: proState Cancer awareness education to pRomote Early screENing uptake2 hour worksop session to foster awareness and encourage screening uptake |
| Control group | Active comparator | Other: Control groupThe control group will receive intervention as usual. This may be in the form of existing prostate cancer screening information provided in hospitals, media and health centres. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men aged between age 18 years and 79 who are not or partially up to date with prostate cancer
- Able to provide full consent for their participation.
- Able to speak the English Language. Able to take part in the intervention and are available for the intervention assessment at baseline and end of intervention.
Key exclusion criteria (5 listed)
- Less than 18 years
- Unable to consent.
- Currently undergoing severe mental health treatment.
- Unable to speak the English language
- not meeting the inclusion criteria.
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 |
|---|---|---|
| proState Cancer awareness education to pRomote Early screENing uptakeThe SCREEN intervention is designed to raise awareness of prostate cancer, its symptoms, implications for late screening, the benefits of early screening, avenues for screening uptake, and also addressing anxiety related to screening uptake. The SCREEN intervention is low-intensity and lasts approximately two hours. | Behavioural | proState Cancer awareness education to pRomote Early screENing uptake (SCREEN) |
| Control groupExisting information provided by health care provider, including media around prostate cancer. | Other | Control group |
Primary outcome
Service Satisfaction Scale
Time frame: At the end of intervention (day 2)
A five item scale that can be used to assess and measure satisfaction, acceptability and quality of the intervention. Higher score denote positive outcomes and acceptability. Lower score denotes poor satisfaction and acceptability.
6 secondary outcomes
Generalised Anxiety Disorder (GAD-7)
Time frame: Baseline (day 1) and at the end of intervention (day 2)]
Oslo Social Support Scale (OSSS-3)
Time frame: Baseline (day 1) and at the end of intervention (day 2)
European Quality of Life Scale EQ-5D-5L
Time frame: Baseline (day 1) and at the end of intervention (day 2)
Knowledge of prostate cancer and screening scale
Time frame: Baseline (day 1) and at the end of intervention (day 2)]
Beliefs around prostate cancer and screening intention scale
Time frame: Baseline (day 1) and at the end of intervention (day 2)
Intention to test for prostate cancer scale
Time frame: Baseline (day 1) and at the end of intervention (day 2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Background: PubMed 31068988Rawla P. Epidemiology of Prostate Cancer. World J Oncol. 2019 Apr;10(2):63-89. doi: 10.14740/wjon1191. Epub 2019 Apr 20.
- Background: PubMed 41299322Dozie INS, Chukwuocha UM, Innocent DC, Dozie UW, Chukwuemeka PS. A systematic review and meta-analysis of the prevalence and risk factors of prostate cancer in Nigeria. BMC Cancer. 2025 Nov 26;25(1):1932. doi: 10.1186/s12885-025-15358-4.
- Background: PubMed 39421165Abdus-Salam AA, Jimoh MA, Folasire AM, Ntekim AI, Ojo OT, Ehiedu CG, Yusuf SA, Takure AO, Akinlade BI, Idowu OK, Oladeji AA, Sarimiye FO, Adenipekun AA. Sociodemographic and clinicopathologic characteristics of patients treated with high dose rate prostate brachytherapy in Nigeria. Ecancermedicalscience. 2024 Aug 14;18:1740. doi: 10.3332/ecancer.2024.1740. eCollection 2024.
- Individual participant dataSharing planned: No. Data supporting this study cannot be made available due to the sensitive nature and ethical reasons on confidentiality.
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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.
Dung E Jidong, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing proState Cancer awareness education to pRomote Early screENing uptake in people with Anxiety and Prostate Cancer, run by Teesside University.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tarela J Ike, Dr (0164234231, T.ike@tees.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Service Satisfaction Scale (time frame: At the end of intervention (day 2)). 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 NCT07800390, which also lists 3 linked publications.
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 2 Sep 2026.