AzTrials
AzTrials

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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

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
What is being tested?
cervical cancer Awareness education to aid Confidence and screening upTake (ACT)
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
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 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.

Tarela J Ike, Dr contact

0164234231

T.ike@tees.ac.uk

Dung E Jidong, PhD contact

Dung.jidong@manchester.ac.uk

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.

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 groups in NCT07863596
Study groupRoleWhat they receive
cervical cancer Awareness education to aid Confidence and screening upTake (ACT)Experimental2 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 groupActive comparatorThe 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.

  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.

    Measured: [At the end of intervention (day 2)]

Secondary outcomes (7)

  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.

    Measured: 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.

    Measured: 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).

    Measured: Baseline (day 1) and at the end of intervention (day 2)

  4. 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)

  5. 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)

  6. 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)

  7. 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.

  1. First posted7 Oct 2026
  2. Study start12 Oct 2026 (estimated)
  3. Primary completion12 Sep 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

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)
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 31759351

  • Olubodun 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 42302027

  • Isa 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

Questions about this trial

What is this clinical trial studying?

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.

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 4 inclusion and 3 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 7 Oct 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 NCT07863596, 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 7 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in