NCT Number: NCT07800390
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.
Trial opening soon.
Get Notified18 year–70 year
Male
Interventional
Not applicable
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Existing information provided by health care provider, including media around prostate cancer.
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.
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.
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.
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).
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Teesside University
Other
Acronym: SCREEN
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