Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000931370
Ethics application status
Approved
Date submitted
1/06/2017
Date registered
27/06/2017
Date last updated
27/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the psycho-social benefits of community-based follow-up, hospital-based follow-up or patient choice of follow-up following treatment of cervical cell abnormalities.
Scientific title
Evaluating the psycho-social benefits of community-based follow-up, hospital-based follow-up or patient choice of follow-up following treatment of cervical cell abnormalities.
Secondary ID [1] 292106 0
Nil
Universal Trial Number (UTN)
U1111-1197-3002
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical Intraepithelial Neoplasia Grade 2 or 3 303525 0
Condition category
Condition code
Cancer 302936 302936 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 298251 0
Treatment: Other
Intervention code [2] 298298 0
Behaviour
Comparator / control treatment
Standard follow-up is hospital-based colposcopy follow-up as described above.
Control group
Active

Outcomes
Primary outcome [1] 302333 0
Psycho-social outcomes between groups (Health-related Quality of Life scores using the Short Form Health Survey 12 version 2 {SF12V2})
Timepoint [1] 302333 0
At time of LLETZ treatment and at 6-month follow-up
Primary outcome [2] 302334 0
By review of medical records patient adherence to follow-up will be assessed (i.e., attendance at allocated or chosen 6-month follow-up appointment).
Timepoint [2] 302334 0
6 months after LLETZ treatment
Secondary outcome [1] 335528 0
Patient preferences to follow-up regimes. Patients were asked, via a questionnaire designed for this study, which method of follow-up would be their preferred method (i.e., hospital- or community-based follow-up 6 months after their LLETZ treatment for cervical cell abnormalities).
Timepoint [1] 335528 0
At time of LLETZ treatment and at 6-month follow-up
Secondary outcome [2] 335529 0
Cost effectiveness analysis comparing the direct cost to hospital and patient through each of the three follow-up methods was undertaken based on hospital and community cost records with the addition of the cost of assessment, missed appointments, recall, re-referral, and subsequent appointments.
Timepoint [2] 335529 0
6 months after LLETZ treatment
Secondary outcome [3] 335530 0
Rate of re-referral to colposcopy in the community-based follow-up group was assessed based on medical record review.
Timepoint [3] 335530 0
6 months after LLETZ treatment

Eligibility
Key inclusion criteria
Women aged 18-70 years
New diagnosis of CIN2 or 3 appropriate for LLETZ treatment
Minimum age
18 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
<18 years of age
Immunosuppressed
History of cancer or other gynaecological cellular abnormalities
Unable to give informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
27/03/2013
Date of last participant enrolment
Anticipated
Actual
29/09/2014
Date of last data collection
Anticipated
Actual
9/12/2015
Sample size
Target
200
Accrual to date
Final
200
Recruitment outside Australia
Country [1] 8948 0
New Zealand
State/province [1] 8948 0
Canterbury

Funding & Sponsors
Funding source category [1] 296637 0
University
Name [1] 296637 0
University of Otago
Country [1] 296637 0
New Zealand
Funding source category [2] 296638 0
Charities/Societies/Foundations
Name [2] 296638 0
Gynaecology Cancer Research Trust
Country [2] 296638 0
New Zealand
Funding source category [3] 296639 0
Other Collaborative groups
Name [3] 296639 0
The Canterbury Initiative
Country [3] 296639 0
New Zealand
Funding source category [4] 296640 0
Charities/Societies/Foundations
Name [4] 296640 0
Royal Australian and New Zealand College of Obstetricians and Gynaecologists
Country [4] 296640 0
Australia
Primary sponsor type
University
Name
University of Otago
Address
Private Bag 4711
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 295599 0
Government body
Name [1] 295599 0
Canterbury District Health Board
Address [1] 295599 0
Private Bag 4710
Christchurch 8140
Country [1] 295599 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297868 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 297868 0
1 the Terrace
PO Box 5013
Wellington 6140
Ethics committee country [1] 297868 0
New Zealand
Date submitted for ethics approval [1] 297868 0
23/09/2009
Approval date [1] 297868 0
31/05/2012
Ethics approval number [1] 297868 0
URA/11/10/056/AM01

Summary
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.
Trial website
Trial related presentations / publications
No abstracts or publications have been published.
Public notes

Contacts
Principal investigator
Name 75322 0
Dr Katayoun Taghavi
Address 75322 0
Department of Obstetrics and Gynaecology
University of Otago, Christchurch
Private Bag 4710
Christchurch 8140
Country 75322 0
New Zealand
Phone 75322 0
+64 3 364 4625
Fax 75322 0
Email 75322 0
[email protected]
Contact person for public queries
Name 75323 0
A/Prof Peter Sykes
Address 75323 0
Department of Obstetrics and Gynaecology
University of Otago, Christchurch
Private Bag 4710
Christchurch 8140
Country 75323 0
New Zealand
Phone 75323 0
+64 3 364 4630
Fax 75323 0
Email 75323 0
[email protected]
Contact person for scientific queries
Name 75324 0
A/Prof Peter Sykes
Address 75324 0
Department of Obstetrics and Gynaecology
University of Otago, Christchurch
Private Bag 4710
Christchurch 8140
Country 75324 0
New Zealand
Phone 75324 0
+64 3 364 4630
Fax 75324 0
Email 75324 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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