proState Cancer Health Education to pRomote Early sreENing Uptake (SCREEN): A Pilot Randomised Control Trial (SCREEN)

August 29, 2026 updated by: Tarela Ike, Teesside University
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

74

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 Contact

Study Contact Backup

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Less than 18 years
  • Unable to consent.
  • Currently undergoing severe mental health treatment.
  • Unable to speak the English language
  • not meeting the inclusion criteria.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: proState Cancer awareness education to pRomote Early screENing uptake (SCREEN)
2 hour worksop session to foster awareness and encourage screening uptake
Behavioral: proState Cancer awareness education to pRomote Early screENing uptake
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.
Active Comparator: Control group
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.
Other: Control group
Existing information provided by health care provider, including media around prostate cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the end of intervention (day 2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oslo Social Support Scale (OSSS-3)
Time Frame: Baseline (day 1) and at the end of intervention (day 2)
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.
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)
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).
Baseline (day 1) and at the end of intervention (day 2)
Generalised Anxiety Disorder (GAD-7)
Time Frame: Baseline (day 1) and at the end of intervention (day 2)]
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.
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)]
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.
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)
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.
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)
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.
Baseline (day 1) and at the end of intervention (day 2)

Collaborators and Investigators

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

Sponsor

Teesside University

Collaborators

University of Manchester
Jos University Teaching Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

September 15, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

August 29, 2026

First Submitted That Met QC Criteria

August 29, 2026

First Posted (Actual)

September 2, 2026

Study Record Updates

Last Update Posted (Actual)

September 2, 2026

Last Update Submitted That Met QC Criteria

August 29, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0000-0003-0516-0313k

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data supporting this study cannot be made available due to the sensitive nature and ethical reasons on confidentiality.

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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