A study looking at the follow up care after treatment for cancer of the cervix, womb, ovary and vulva (TOPCAT-G)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Cervical cancer
Ovarian cancer
Vulval cancer
Womb (uterine or endometrial) cancer

Status:

Closed

Phase:

Pilot

This study is looking at the follow up care after treatment for women’s cancers. It is for women with one of the following

These cancers are sometimes called gynaecological cancers.

More about this trial

Women are routinely followed up with regular hospital appointments for a number of years after they have finished treatment. The purpose of follow up care is to find out if women have any side effects and to pick up possible signs of the cancer coming back.

Doctors don’t yet know the best way to follow up women with gynaecological cancers and so there may be differences in the care that women receive.

Researchers think a new nurse led approach, carried out mainly over the telephone, could benefit women following their cancer treatment. Half of the women in this study will have nurse led follow up care. The other half will have doctor led hospital based appointments, this is standard follow up care at the moment.

This is a feasibility study. The researchers want to find out if it is possible to carry out similar research with a larger number of women in the future. The aims of this study are to find out

  • If it is possible to recruit women to this study
  • What women think of these different approaches
  • Whether it is possible to collect reliable information about the women taking part. For example, information about quality of life and how long people live for

If this study is successful, the researchers then hope to carry out a larger trial to compare the 2 different approaches.

Who can enter

You may be able to join this study if you are a patient at Ysbyty Gwynedd Hospital, Ysbyty Glan Clwyd Hospital and Ysbyty Maelor Hospital (part of the North Wales Cancer Network) and you have finished treatment for one of the following cancers in the last 3 months

  • Cervical cancer
  • Endometrial (womb) cancer
  • A type of ovarian cancer called epithelial cancer
  • Primary peritoneal cancer
  • Fallopian tube cancer
  • Vulval cancer 

You cannot join this study if you need further treatment for your cancer, or you have had treatment for 1 of the following types of gynaecological cancer

Trial design

This is a feasibility study. The researchers need 50 women to take part.

It is randomised, the people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in

  • One group have nurse led follow up care via telephone 
  • The other group have doctor led follow up care via hospital appointments. This is the control group Open a glossary item

TOPCAT-G trial diagram

If you are in the group having nurse led follow up care, you have a hospital appointment within 3 months of finishing your treatment. The research nurse will introduce you to the clinical nurse specialist (CNS) who is going to carry out your follow up care.

The CNS will give you an information booklet to take home. This includes information about the

  • Side effects of treatment (physical and psychological) and help that is available
  • Possible signs of the cancer coming back (recurrence)
  • Contact details if you have any concerns

The CNS will arrange a telephone appointment for a date and time that suits you. You complete a questionnaire at home about 1 week before the telephone appointment. This is called a needs assessment questionnaire and it is designed to help you identify what concerns and needs you have.

During your telephone call the CNS will ask how you are and whether you have any symptoms. If appropriate, your CNS may arrange appointments with your consultant or other hospital teams, or signpost you to other sources of help and support.

You will fill in the needs assessment questionnaire again and have a second telephone call with the CNS about 6 months later. A date and time can be arranged that suits you. You are encouraged to contact the CNS at any time in between phone calls if you have concerns.

If you are in the second group, you have standard follow up care. You have hospital appointments with a doctor 3 months, 6 months and 9 months after treatment. A doctor will examine you, ask how you are and you may have blood tests. Your doctor may recommend you have a scan at some of these appointments.

Women in both groups are asked to fill out some questionnaires 3 months after treatment, then at 6 months and 9 months. You complete the first set of questionnaires with the research nurse at your 3 month follow up appointment. You receive your next 2 questionnaires by post. You can complete these at home and return them in the self addressed envelope provided. These will take about 20 to 30 minutes to do.

The questionnaires will ask how you’re been feeling, about your quality of life and how fit and well you are. This is called a quality of life study.

After your hospital appointment or telephone interview at 9 months your involvement in this study will finish. Your medical team will continue to arrange follow up care for you. How often and what this involves will depend on your circumstances and your local hospital policy. Your CNS or consultant will be able to give you more information about what this.

Hospital visits

Women who have doctor led follow up care will have 2 more hospital visits than those in the nurse led group.

Side effects

This study does not involve a treatment and so there are no side effects. Completing the questionnaires and talking about your concerns may be upsetting. Your doctor or CNS will do all they can to make you comfortable.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Mr Simon Leeson

Supported by

Betsi Cadwaladr University Health Board

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 13393

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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