AnxietyACTNCT07863596
Cervical Cancer Awareness Education to Aid Confidence and Screening upTake (ACT): A Pilot Randomised Control Trial
A study testing cervical cancer Awareness education to aid Confidence and screening upTake (ACT) in people with Anxiety and Cervical Cancer Screening, run by Teesside University.
Trial summary
Cervical cancer remains a major threat to women's health and wellbeing, with the burden disproportionately concentrated in low- and middle-income countries such as Nigeria, where inadequate awareness, limited access to screening, screening-related anxiety, and other structural and sociocultural barriers contribute to… Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Cervical Cancer Screening, Health Education
- What is being tested?
- cervical cancer Awareness education to aid Confidence and screening upTake (ACT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 12 Oct 2026to 30 Sep 2027
- Phase
- Interventional
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 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged between age 18 years and 64 who are not or partially up to date with cervical 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
Cervical cancer remains a major threat to women's health and wellbeing, with the burden disproportionately concentrated in low- and middle-income countries such as Nigeria, where inadequate awareness, limited access to screening, screening-related anxiety, and other structural and sociocultural barriers contribute to low screening uptake, late presentation, and preventable mortality. Despite the urgent need to improve early detection, there remains a critical gap in culturally appropriate, co-produced interventions to address the barriers that shape cervical cancer screening behaviours. The proposed study will address this gap by piloting the feasibility and acceptability of "cervical cancer Awareness education to aid Confidence and screening upTake (ACT)" a novel, low-intensity, co-produced workshop intervention for women who are not up to date or only partially up to date with recommended cervical cancer screening. Delivered over approximately two hours, ACT is designed to increase awareness of cervical cancer and its symptoms, strengthen understanding of the consequences of delayed screening and the benefits of early detection, improve knowledge of available screening pathways, address misconceptions and screening-related anxiety, and build women's confidence and motivation to engage with screening services. In addition to assessing recruitment, retention, intervention engagement, acceptability and implementation feasibility, the study will pilot the proposed outcome measures and data collection procedures to inform a future definitive evaluation. It will also generate preliminary evidence on potential intervention mechanisms, screening-related outcomes, and approaches to assessing cost-effectiveness. Collectively, the study will establish whether ACT is feasible, acceptable and sufficiently promising to progress to a larger-scale trial evaluating its effectiveness and cost-effectiveness in improving cervical cancer screening uptake among women in Nigeria.
- Conditions
- Anxiety, Cervical Cancer Screening, Health Education, Wellbeing
- Being tested
- cervical cancer Awareness education to aid Confidence and screening upTake (ACT), Control group
- Keywords
- anxiety, cervical cancer, screening and brief interventions, cervical cancer screening, health education workshop
- Medical subject headings
- Anxiety Disorders, Health Education, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical cancer Awareness education to aid Confidence and screening upTake (ACT)Behavioural
The ACT intervention is designed to raise awareness of cervical cancer, its symptoms, implications for late screening, the benefits of early screening, avenues for screening uptake, and also addressing anxiety related to screening uptake. It will also address screening related fear. The ACT intervention is low-intensity and lasts approximately two hours.
Other Name:
Control groupOther
Existing information provided by health care provider, including media around prostate cancer.
| Study group | Role | What they receive |
|---|---|---|
| cervical cancer Awareness education to aid Confidence and screening upTake (ACT) | Experimental | 2 hour worksop session to foster awareness and encourage early cervical cancer screening uptake Receives: Behavioral: cervical cancer Awareness education to aid Confidence and screening upTake (ACT) |
| Control group | Active comparator | The control group will receive intervention as usual. This may be in the form of existing cervical 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 (7)
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)
Beliefs around cervical cancer and screening intention scale
A 8-item scale that measure beliefs around cervical cancer, knowledge and intention to engage in screening. Score range from 0-40 with higher score denoting knowledge and strong willingness to engage in early screening uptake.
Measured: Baseline (day 1) and at the end of intervention (day 2)
Cervical Cancer Knowledge Scale
The Cervical Cancer Knowledge Scale is an 8 item scale that measures knowledge of cervical cancer. The scale uses a true, false and don't know to assess knowledge with correct answer denoting higher knowledge.
Measured: Baseline (day 1) and at the end of intervention (day 2)
Cervical Cancer Screening Uptake Questionnaire (CCSTQ) for Women
Cervical Cancer Screening uptake Questionnaire is a 43 item questionnaire that measures six core dimension including
- Social norms
- Knowledge and awareness
- Perceived threat
- Perceived benefits
- Perceived barriers
- Self-efficacy The scale uses a Likert style response and scores. Higher aggregate scores generally reflect positive psychosocial determinants and a stronger likelihood of screening participation.
Measured: Baseline (day 1) and at the end of intervention (day 2)
Cervical Cancer Awareness Measure (Cervical CAM)
The CAM is a Survey tool used to assess public knowledge, risk perception, and attitudes regarding cervical cancer. The standard Cervical CAM comprises 9 core questions broken down into a total of 31 specific items. Scores are calculated by aggregating individual item responses into specific knowledge or awareness sub-scales. Correct identifications are typically assigned a positive score (e.g., 1 or 2 points for a correct 'Yes'), while incorrect answers or 'don't know' responses score 0. Points across sections are summed to create an overall awareness or knowledge score. Higher composite scores reflect greater familiarity with clinical signs and risk factors, and scores are often categorized into binary thresholds (e.g., "good" vs. "poor" awareness) for statistical comparison.
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 posted7 Oct 2026
- Study start12 Oct 2026 (estimated)
- Primary completion12 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
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teesside University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester, Jos University Teaching Hospital
- Responsible party
- Principal investigator, Tarela Ike, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863596
- Sponsor's protocol ID
- 0000-0003-0516-0313L
- Acronym
- ACT
- Status last verified
- Sep 2026
- First submitted
- 2 Oct 2026
- Last updated
- 7 Oct 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
Rimande-Joel R, Ekenedo GO. Knowledge, Belief and Practice of Cervical Cancer Screening and Prevention among Women of Taraba, North-East Nigeria. Asian Pac J Cancer Prev. 2019 Nov 1;20(11):3291-3298. doi: 10.31557/APJCP.2019.20.11.3291.
PubMed 31759351Olubodun T, Luoga P, Adam J. Prevalence and determinants of cervical cancer screening among women aged 30-49 years in Nigeria: A population-based cross-sectional study. PLOS Glob Public Health. 2026 Jun 16;6(6):e0006668. doi: 10.1371/journal.pgph.0006668. eCollection 2026.
PubMed 42302027Isa Modibbo F, Dareng E, Bamisaye P, Jedy-Agba E, Adewole A, Oyeneyin L, Olaniyan O, Adebamowo C. Qualitative study of barriers to cervical cancer screening among Nigerian women. BMJ Open. 2016 Jan 11;6(1):e008533. doi: 10.1136/bmjopen-2015-008533.
PubMed 26754174