proState Cancer Health Education to pRomote Early sreENing Uptake (SCREEN): A Pilot Randomised Control Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-70
SponsorTeesside University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Less than 18 years
Unable to consent.
Currently undergoing severe mental health treatment.
Unable to speak the English language
Trial design
Design model
Parallel
Treatments tested in this trial
proState Cancer awareness education to pRomote Early screENing uptake
BehavioralThe 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 group
Other interventionExisting information provided by health care provider, including media around prostate cancer.
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: proState Cancer awareness education to pRomote Early screENing uptake (SCREEN)Experimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
At the end of intervention (day 2)Secondary outcomes
1
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.
Time frame
Baseline (day 1) and at the end of intervention (day 2)]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.
Time frame
Baseline (day 1) and at the end of intervention (day 2)3
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).
Time frame
Baseline (day 1) and at the end of intervention (day 2)4
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.
Time frame
Baseline (day 1) and at the end of intervention (day 2)]Locations
Sponsors and contacts
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Teesside University
Lead sponsor
Jos University Teaching Hospital
Collaborator
University of Manchester
Collaborator
Source ClinicalTrials.gov
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