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TOMBOLA stands for Trial Of Management of Borderline and Other Low-grade Abnormal smears.
Each year millions of women have a cervical smear taken in the UK as part of the Cervical Screening Programmes. These are looking for cells on the cervix which may have changed. Identifying these cell changes at an early stage help prevent cervical cancer developing. Six in every hundred women will have a cervical smear that shows slight changes in the cells of their cervix. These smears are called “borderline” or “mild”.
Women who have a cervical smear that shows slight changes need to have some follow-up. There are different methods of follow-up. One method is for the woman to have a repeat cervical smear test in around six months. Another method is for her to have a colposcopy examination where the doctor looks at the cervix to see if there are any areas that look abnormal.
People working in the Cervical Screening Programmes do not know which method of follow-up is the best. The TOMBOLA study is being carried out to investigate which method is best, both for women and for the NHS.
TOMBOLA is a clinical trial. In a clinical trial two or more courses of action are compared to see which is best. In TOMBOLA we are comparing different methods of follow-up for women who have a smear that shows slight changes. We are comparing repeat smears with colposcopy examinations. Participants in a clinical trial are allocated, by chance, to one course of action or another.
In order to determine which method of follow-up is best, the study is looking at different aspects of the two methods. We are looking at what happens to the women taking part, how they feel about the different methods, how much each method costs, both to the women, and to the NHS, and any after-effects women may have after a colposcopy examination or a smear.
The TOMBOLA study invited women who had a cervical smear that showed borderline or mild changes who were aged 20 –59 years old and lived in Grampian, Tayside or Nottingham to take part. Recruitment to the study took place from October 1999 to February 2003. More than 4400 women are taking part in TOMBOLA.
We invited women to come along for an appointment at their local TOMBOLA recruitment clinic. If women agreed to take part in the study, we allocated them, by chance, to either:
If a woman was allocated to follow-up method A, we asked her to go back to her GP surgery (or family planning clinic) for another smear in around six months time, and then every six months. If a woman has three smears that were normal, she is returned to regular screening (i.e. a smear every three years). If any of her smear results showed more than slight changes we arranged for the woman to have a colposcopy examination at her local hospital.
If a woman was allocated to follow-up method B, we invited her to an appointment at the TOMBOLA clinic for a colposcopy examination (there is more information about colposcopy examinations below). At the colposcopy appointment the doctor or specialist nurse looked at the woman’s cervix. If the cervix looked normal, the woman did not need any further tests or treatment at that time. If the doctor saw an area on the cervix that looked abnormal we invited the woman to take part in a second part of TOMBOLA. This was comparing two methods of treatment. The two methods were:
Treatment Method 1: The doctor/specialist nurse took small samples (biopsies) of the area on the cervix that looked abnormal. These were sent to the laboratory for analysis. If the biopsies were found to be abnormal, we asked the woman to attend the TOMBOLA clinic for treatment. If the biopsies were normal, the woman did not need further treatment.
Treatment Method 2: The doctor/specialist nurse treated the area on the cervix that looked abnormal during the colposcopy appointment.
If the woman agreed to this part of the study, she was allocated by chance to method 1 or method 2.
After a woman has had colposcopy, and any treatment, she is followed-up with regular smears.
In TOMBOLA we are following women for 3 years after they join the study. During this time we collect information on all the smears and any colposcopy appointments or treatment they have. We also send women questionnaires to collect other information about their follow-up. There is more information about the study questionnaires used in the next section.
At the end of their 3 years in the TOMBOLA study we invite women back to the TOMBOLA clinic for a final appointment. At this appointment they will have a colposcopy examination. The doctor/ specialist nurse carries out a thorough examination of the woman’s cervix and treats any area that looks abnormal. You can read more about the final appointment by clicking here.
At the first appointment at the TOMBOLA clinic we ask women to fill in a questionnaire about themselves and their lifestyle. We asked some women to also complete a questionnaire about how they felt since receiving their smear result.
During a woman’s three years in the TOMBOLA study, she may be asked to complete a number of other questionnaires. Some of these help us measure how women feel about their follow-up and what impact, if any, it has had on their well-being. Information from these questionnaires will help us understand how women feel when they have a smear showing slight changes and their experiences of being followed-up by colposcopy or six monthly repeat smears. Other questionnaires help us find out how much each method of follow-up costs women in terms of travel, time off work, child-care etc. These questionnaires will also help us ensure we have counted all the NHS costs involved in each method of follow-up. We also ask women to fill in questionnaires about any after-effects they might have after having a smear or a colposcopy examination.
All the information from the questionnaires women complete will help us determine which method of follow-up is best for women who have a smear that shows slight abnormalities.
If you have any questions about the questionnaires you are asked to fill in as part of TOMBOLA, please call us on 0800 056 4343.
4474 in total spilt across three centres:
Study area |
Grampian Centre |
Tayside Centre |
Nottingham Centre |
|---|---|---|---|
Total number of participants |
1487 |
1104 |
1883 |
We will combine the information collected from all the women taking part in TOMBOLA. We will use the information we collected at the appointments a women has attended, about the smears she has had and from the questionnaires she has completed. We will analyse this information to find out which method of follow-up is best, both for women and for the NHS. The Medical Research Council, who funded this study, will receive a report with all the results from TOMBOLA. We will also publish the results in medical journals. In these published results it will not be possible to identify anyone who took part in the study. The results will also be made available to people who work in the Cervical Screening Programmes and will be published on this website.
November 1999 We started recruiting women into TOMBOLA.
January 2003 We stopped recruiting women into TOMBOLA. Nearly 4,500 women were recruited.
February 2003 We started inviting women for their final appointment in TOMBOLA
December 2005 By December 2005 we will have invited all the women taking part in TOMBOLA for their final appointment. We hope that all the women who agreed to take part in the study will come for their final appointment. Please help us reach our target by coming to your final appointment when we invite you.
June 2006 The final results from TOMBOLA will start to become available.
TOMBOLA
Department of Public Health · University of Aberdeen · School of Medicine · Polwarth Building · Aberdeen AB25 2ZD
Tel: 01224 559408 | tombola@abdn.ac.uk