ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Condition category

Condition code

Cancer

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]

Treatment: Other

Intervention code [2]

Behaviour

Comparator / control treatment

Standard follow-up is hospital-based colposcopy follow-up as described above.

Control group

Active

Outcomes

Primary outcome [1]

Psycho-social outcomes between groups (Health-related Quality of Life scores using the Short Form Health Survey 12 version 2 {SF12V2})

Timepoint [1]

At time of LLETZ treatment and at 6-month follow-up

Primary outcome [2]

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]

6 months after LLETZ treatment

Secondary outcome [1]

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]

At time of LLETZ treatment and at 6-month follow-up

Secondary outcome [2]

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]

6 months after LLETZ treatment

Secondary outcome [3]

Rate of re-referral to colposcopy in the community-based follow-up group was assessed based on medical record review.

Timepoint [3]

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?

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]

New Zealand

State/province [1]

Canterbury

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Otago

Address [1]

Private Bag 4711
Christchurch 8140

Country [1]

New Zealand

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Gynaecology Cancer Research Trust

Address [2]

PO Box 36665
Merivale
Christchurch 8146

Country [2]

New Zealand

Funding source category [3]

Other Collaborative groups

Name [3]

The Canterbury Initiative

Address [3]

32 Oxford Terrace
CDHB Building, Level 2
Christchurch 8140

Country [3]

New Zealand

Funding source category [4]

Charities/Societies/Foundations

Name [4]

Royal Australian and New Zealand College of Obstetricians and Gynaecologists

Address [4]

College House
254–260 Albert Street
East Melbourne
Victoria 3002 Australia

Country [4]

Australia

Primary sponsor type

University

Name

University of Otago

Address

Private Bag 4711
Christchurch 8140

Country

New Zealand

Secondary sponsor category [1]

Government body

Name [1]

Canterbury District Health Board

Address [1]

Private Bag 4710
Christchurch 8140

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Health and Disability Ethics Committee

Ethics committee address [1]

1 the Terrace
PO Box 5013
Wellington  6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

23/09/2009

Approval date [1]

31/05/2012

Ethics approval number [1]

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

Dr Katayoun Taghavi

Address

Department of Obstetrics and Gynaecology
University of Otago, Christchurch
Private Bag 4710
Christchurch 8140

Country

New Zealand

Phone

+64 3 364 4625

Fax

katayoun.taghavi@gmail.com

Contact person for public queries

Name

Peter Sykes

Address

Department of Obstetrics and Gynaecology
University of Otago, Christchurch
Private Bag 4710
Christchurch 8140

Country

New Zealand

Phone

+64 3 364 4630

Fax

Peter.sykes@otago.ac.nz

Contact person for scientific queries

Name

Peter Sykes

Address

Department of Obstetrics and Gynaecology
University of Otago, Christchurch
Private Bag 4710
Christchurch 8140

Country

New Zealand

Phone

+64 3 364 4630

Fax

Peter.sykes@otago.ac.nz

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

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically