None listed
Conditions
Brief summary
The study aimed to identify patient preferences and investigate whether type of follow-up was associated with differences in Health-related Quality of Life (HrQOL), adherence to screening, or cost benefits in patients who have undergone large loop excision of the transformation zone (LLETZ) procedures for cervical intraepithelial neoplasia (CIN) stages two and three. The study was a three arm, parallel-group, open label randomised controlled trial of women aged 18 70, with a new diagnosis of CIN 2-3, at Christchurch Women’s Hospital. The control group (n= 69) had routine follow-up with colposcopy review at the hospital, six months post treatment. Two intervention groups were also examined: one having follow-up by high-risk human papilloma virus (HrHPV) and smear testing in the community (n = 66), and the second group who selected their follow-up regime (either hospital-based colposcopy or HrHPV and smear tests in the community, n = 65). Assessments were conducted at time of treatment and at 6 months by questionnaire. The two intervention groups were compared with the control group. Comparisons between the choice versus no-choice groups were also made. The primary outcome of the study was an analysis of HrQOL scores using the Short Form Health Survey 12 version 2 (SF12v2). The secondary outcomes of the study include percentage of normal follow-up tests, detection of recurrent disease, patient preferences, adherence to screening recommendation, and cost analysis with comparison between the groups. This study investigated 200 women who received LLETZ treatment at Christchurch Women’s Hospital between 2013 and 2015. The baseline characteristics of the groups were similar. Seventy-six women (38%) were randomised to the control group, 63 (32%) were randomised to follow-up in the community with smear and HrHPV testing, and 61 (31%) were offered the choice to select their follow-up regime. Of those given a choice of follow-up, 22 (36%) chose to have their follow-up in the community and 39 (64%) chose to have follow-up in the colposcopy department. At 6 months, the SF12v2 scores for HrQOL were not significantly different between the groups. There was, however, a four times greater likelihood that patients in the choice group would adhere to follow-up. There are cost benefits to both community and choice of follow-up (with savings of $59 and $33 dollars per person, respectively). N=122 women (61%) had no evidence of disease by 6 months (had normal smears and negative HrHPV tests). Although there were no significant correlations with smoking status or OCP use, the trends were in the expected direction. One patient experienced treatment failure and required a repeat LLETZ, while another was found to have a 1A1 squamous cell carcinoma and was referred for Gynaecology Oncology follow-up.
Interventions
Randomized controlled trial of women who had undergone Large Loop Excision of the Transformation Zone (LLETZ) treatment for cervical intraepithelial neoplasia (CIN) grade 2 or 3 to investigate the psycho-social benefits of different 6-month follow-up methods (hospital-based colposcopy follow-up, community-based follow-up, or patient choice of follow-up method). Hospital-based colposcopy follow-up is the usual follow-up method following LLETZ treatment in New Zealand. This involves colposcopic examination (and biopsy if a cervical lesion is observed), high risk human papillomavirus (HRHPV) test, and smear (cytology) at a hospital-based colposcopy clinic and undertaken by a trained colposcopist.. Community-based follow-up involves high risk human papillomavirus (HRHPV) test and smear (cytology) undertaken by a community smear taker (trained general practitioner or nurse). Patient choice of follow-up method involved the patient choosing either hospital- or community-based follow-up. Community-based follow-up for the trial is at is at 6 months only. Further follow-ups depend on smear results. If either cytology is abnormal or high risk human papillomavirus (HPV) test is positive, the woman will be referred back to colposcopy clinic in the hospital. Otherwise, a follow-up smear and HPV in the community in 6 months is recommended Hospital-based follow-up for the trial is at is at 6 months only. Further follow-ups will be as per specialist advice according to NSCP guidelines.
Sponsors
Study design
Eligibility
Inclusion criteria
Women aged 18-70 years New diagnosis of CIN2 or 3 appropriate for LLETZ treatment
Exclusion criteria
<18 years of age Immunosuppressed History of cancer or other gynaecological cellular abnormalities Unable to give informed consent