Strategies to Improve the Experience of Gynaecological Screening

Status Enrolling by invitation

Clinical Trial Summary

Clinical Trial Description

The aim is to evaluate different strategies to improve the experience and effect of the first visit for a cervical screening test (CST). 1. How do the context and the allotted time for the first visit for a CST affect women's i) experience of CST ii) knowledge of and attitudes towards CST and cervical cancer and iii) attitude towards contacting a midwife regarding sexual and reproductive health in the future 2. What effects do the RLP have, when used as a starting point for counselling at the first visit for a CST, on women's i) experience of CST ii) knowledge of and attitudes towards CST and cervical cancer iii) attitude towards contacting a midwife regarding sexual and reproductive health in the future and iv) knowledge of and attitudes towards fertility and preconception health The study is a cluster randomized controlled trial evaluating different strategies, RLP-based information, to improve the experience and effect of the first visit for a cervical screening test (CST). The study will be conducted in a strategically chosen area which includes both rural and urban areas, high and low socioeconomic status and high and low percentage of immigrant visitors. The study is conducted in four steps: 1. Standard care for CST at the midwifery clinic (control group) 2. Standard care for CST at the youth clinic (intervention group 1) 3. Standard care for CST at the youth clinic with extra time allotted (intervention group 2) 4. Standard care for CST at the youth clinic with extra time allotted and the RLP-information (intervention group 3) Step 2-4 will be conducted during different time periods at the same youth clinics. Recruitment for each step will be ongoing until the necessary number of participants are reached. All participating providers will be carefully instructed during educational sessions and provided with material on how to inform their visitors about the study. The providers at youth clinics will also receive oral information regarding how to execute the intervention and written materials (intervention guide, checklist) to ensure uniformity. During the project period, all providers will approach all adolescents visiting for CST and keep log over the visits to enable analysis of non-participants. Participating adolescents in all groups will be asked to complete digital questionnaires after their visit. Primary outcomes: knowledge and awareness of CST, cervical cancer, fertility, and preconception health. Secondary outcomes: experience of the visit and likelihood to contact a midwife regarding questions about sexual or reproductive health in the future. The power calculation is based on results by Stern et al. (2013) showing that university students increased knowledge by 40% after an RLP-intervention. The calculation assumed both greater variety in and lower increase in knowledge among adolescents than among university students. To detect a difference between the intervention and control group with 80% power and with a significance level of p< 0.05, 50 adolescents are needed in each group. We expect high participation rate and plan to recruit 75 adolescents in each group, i.e. 300 adolescents. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05131581
Study type	Interventional
Source	Uppsala University
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	November 1, 2021
Completion date	June 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06223308` - A Study Evaluating the Safety and Efficacy of HB0028 in Subjects With Advanced Solid Tumors	Phase 1/Phase 2
Terminated	`NCT03367871` - Combination Pembrolizumab, Chemotherapy and Bevacizumab in Patients With Cervical Cancer	Phase 2
Active, not recruiting	`NCT04537156` - Efficacy, Immunogenicity and Safty Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)	Phase 3
Recruiting	`NCT03668639` - Safety and Antiemetic Efficacy of Akynzeo Plus Dexamethasone During Radiotherapy and Concomitant Weekly Cisplatin	Phase 2/Phase 3
Active, not recruiting	`NCT04242199` - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors	Phase 1
Withdrawn	`NCT04806945` - A Phase III Study to Evaluate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy in Patients With Advanced Cervical Cancer	Phase 3
Active, not recruiting	`NCT04185389` - Long-Term Follow-Up of HPV FOCAL Participants
Withdrawn	`NCT03007771` - Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia	Phase 1
Completed	`NCT03384511` - The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.	Phase 4
Recruiting	`NCT05107674` - A Study of NX-1607 in Adults With Advanced Malignancies	Phase 1
Completed	`NCT05120167` - Strategies for Endocervical Canal Investigation in Women With Abnormal Screening Cytology and Negative Colposcopy	N/A
Recruiting	`NCT05483491` - KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer	Phase 1
Recruiting	`NCT05736588` - Elimisha HPV (Human Papillomavirus)	N/A
Completed	`NCT05862844` - Promise Women Project	N/A
Recruiting	`NCT04934982` - Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IA1 With LVSI, IA2)	N/A
Recruiting	`NCT03876860` - An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis	N/A
Completed	`NCT03652077` - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies	Phase 1
Completed	`NCT00543543` - Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001)	Phase 3
Terminated	`NCT04864782` - QL1604 Plus Chemotherapy in Subjects With Stage IVB, Recurrent, or Metastatic Cervical Cancer	Phase 2/Phase 3
Recruiting	`NCT04226313` - Self-sampling for Non-attenders to Cervical Cancer Screening	N/A