A study looking at a decision aid to help people make choices about their treatment (SHARE-IT)

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

Cancer type:

Breast cancer

Status:

Closed

Phase:

Other

This study is looking at a decision aid to help women make choices about their breast cancer treatment. The decision aid has been developed for people with a variety of medical conditions. In this study the researchers are testing its use in women with breast cancer who are considering whether to continue with their hormone therapy.

More about this trial

Making decisions about treatment can be very difficult. Some people with cancer may need to decide whether to have treatment. Or may be offered the choice of different treatments and so they have to consider

  • The possible benefits of each treatment
  • The potential side effects
  • The impact of this treatment on their daily life

This study is looking at a tool called a decision aid. Decision aids are already used in the NHS. The decision aid used in this study is slightly different to some existing tools because it helps you and your doctor decide together about the best treatment for you.

Many women who have had treatment for breast cancer take tamoxifen for 5 years. This is because it reduces the risk of the cancer coming back (recurrence). Recent research has shown that taking tamoxifen for a further 5 years (10 years in total) can further reduce the risk of the cancer coming back.

But taking tamoxifen has side effects. Generally doctors think the benefits of taking tamoxifen for longer than 5 years outweighs the risks. But they recognise that not all their patients will want to do this. Deciding whether to continue tamoxifen may be a difficult decision for some women.

The aims of this study are to

  • Develop and test a decision aid to be used by the patient and doctor when discussing whether to continue with hormone therapy
  • Find out if the decision aid can be understood and used easily

If this study is successful, the researchers hope to carry out larger studies to find out how effective this decision aid is in helping people come to decisions.

Who can enter

You may be able to join this study if you have had breast cancer and you are a patient at

  • Aberdeen Royal Infirmary
  • Beatson West of Scotland Cancer Centre (Glasgow)
  • Ninewells Hospital (Dundee)

Your doctor may ask you to take part if you have had tamoxifen for about 5 years and you are considering whether to continue this treatment for a further 5 years.

Trial design

This international study needs to recruit about 16 people in the UK (about 80 people worldwide).

If you take part, a researcher will be present at your appointment with your doctor. They will listen to the conversation you have with your doctor about treatment and they may take notes if the decision aid is used.

The decision aid is electronic, so it is used on devices such as computers, tablets or smartphones. The doctor will guide you through the decision aid so it doesn’t matter if you don’t normally use any of these devices.

The decision aid presents information about the benefits of taking tamoxifen for longer than 5 years and about the side effects. It will provide the best available evidence for each. The decision aid will also ask questions about what is important to you and whether you have any particular concerns or needs.

The researcher will ask your permission to audio record the conversation. You don’t have to agree to the recording if you don’t want to.

After your appointment you fill in a short questionnaire about your conversation with your doctor. The researcher will then ask for your thoughts on the decision aid. This will take about 20 minutes. You don't have to agree to the interview if you don’t want to.

Your doctor will also be interviewed by the researcher to get their feedback on using the decision aid. For example, the study team would like to know, in the doctor’s opinion, whether the decision aid was easy to use and helped the discussion.

All the information collected about you is treated as confidential Open a glossary item. The recordings will be stored securely for a year then destroyed. No one will be able to link the results to you. Any personal information such as your name and contact details is removed and not kept.

Hospital visits

Taking part in this trial will be part of a planned appointment with your doctor.  It may extend your hospital visit by about 30 minutes.

Side effects

As this is not a treatment trial there are no side effects associated with taking part.

You may find using the decision aid or having the researcher in the room makes your discussion with your doctor awkward. Or you may find it upsetting talking about your cancer and treatment. Your medical team will offer you support if needed.

However, using the decision tool with your doctor may help you to come to a decision about your treatment.

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

Dr Shaun Treweek

Supported by

Aberdeen Royal Infirmary
European Union
Ninewells Hospital and Medical School
The Beatson West of Scotland Cancer Centre

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 13361

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

Deborah wanted to help other breast cancer patients in the future

A picture of Deborah

“Deborah agreed to take part in a trial as she was keen to help other cancer patients in the future. "If taking part in a trial means others might be helped then I’m very happy with that."

Last reviewed:

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