A trial looking at how women feel about themselves after breast reconstruction during surgery for breast cancer (QUEST A)

This trial is comparing women’s feelings after having one of 2 types of surgery to make a new breast shape (breast reconstruction) at the same time as surgery to have their breast removed (mastectomy).

This trial is looking at the most common type of reconstruction surgery, which creates a new breast shape using muscle from your back and tissue from under your shoulder blade. It is called latissimus dorsi breast reconstruction (LDBR). There are 2 ways to carry out LDBR. The back flap method is when your new breast is made from muscle, fat and skin from your back. The implant assisted method uses the same muscle, but less fat and skin. Instead it uses a salt water or silicone implant to create the breast shape.

We already know that both methods give good cosmetic results. But researchers want to find out how each method affects women’s satisfaction with the procedure, well being and quality of life. They will ask women to complete a series of questionnaires at different stages of their treatment. They will also gather information about their treatment from their hospital records. They hope that in future, information from this trial will help women having this surgery to understand more about how they might feel with each method. It will also help them to make a more informed decision about their treatment.

You will not get any direct benefit from taking part in this trial, and it is unlikely to change your treatment plan in any way. The results will be used to help women with breast cancer in the future.

Recruitment

Start 09/07/2011

End 30/09/2012

Phase

Pilot

Who can enter

You can enter this trial if you

Have invasive breast cancer or ductal carcinoma in situ (DCIS)
Need to have your affected breast removed (mastectomy), and are fit enough to have this operation
Have chosen to have latissimus dorsi breast reconstruction (LDBR)
Are not expected to need radiotherapy after your surgery
Would be able to understand and complete the trial questionnaires

You cannot enter this trial if you

Are having surgery to prevent or reduce the risk of breast cancer
Have had radiotherapy to your breast
Have cancer in both breasts
Have had surgery just to remove the cancer from your breast (wide local excision or lumpectomy)
Have breast cancer that has come back after treatment
Have breast cancer that has spread to a distant part of your body, and this has been confirmed by a chest X-ray or a scan
Have had any other cancer, apart from non melanoma skin cancer that has been successfully treated
Have any other condition that may make you unwell if you took part, or affect the results of the trial – you can check this with your doctor

Trial design

This trial will recruit 55 women. It is randomised. Everyone will be put into one of 2 groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group 1, you will have the back flap breast reconstruction.
If you are in group 2, you will have the implant assisted breast reconstruction.

Whichever group you are in, you will have your breast reconstruction at the same time as your mastectomy. Your surgeon and nurse will talk to you more about what your particular surgery will involve.

During the trial, the hospital team will collect all the information on your operation and recovery.

At different points during the trial, you will also fill out a booklet containing 5 simple questionnaires. The booklet should take about half an hour to complete. You will complete the first booklet before you know which type of reconstruction you will have. If you are happy to carry on in the trial, the team will send you the same booklet to fill out at home at

3, 6 and 12 months after your surgery
2, 3, 4 and 5 years after your surgery

You return the questionnaires in a prepaid envelope. The questionnaires will ask about

Your general health and well being
Your breast cancer
How you imagine yourself physically (your body image)
Your breast reconstruction
Any anxiety or depression you may have had

Throughout the trial, you stay under the care of your own breast cancer specialist.

During QUEST Trial A, you will be approached to take part in an extra study, called the ‘Patients’ Views on QUEST (PVQ) Study’.

The PVQ study aims to find out what women think about being asked to take part in QUEST Trial A, how they feel about making the decision and their experiences if they took part. You will be asked to

Fill out a questionnaire
Have a telephone interview (at least a month after your surgery) – not everyone will be asked for this
Fill out some more questionnaires at 15 and 24 months after your surgery (only for those women who did take part in QUEST A)

Hospital visits

If you take part in this trial, you will make one extra visit to hospital to formally agree to join the trial, and find out which type of surgery you will have.

Side effects

If the questionnaire answers you give show that you may have anxiety or depression, the trial team will tell your breast surgeon and your GP so you can get help if you need it.

You will not have any extra risks from taking part in QUEST Trial A other than those that anyone having mastectomy and breast reconstruction may have. Both reconstruction procedures can have complications, including

Collection of fluid under the skin of your breast and back after surgery (seroma)
Tightness or stiffness in your back
Delayed wound healing and scarring
Poor blood supply to fatty tissue in the reconstructed breast, leading to temporary skin redness, and a possible area of firmness in the new breast (this is uncommon)
Poor blood supply to the skin edges of breast or back wounds, causing a scab or increased scarring (this is more common in smokers)

Rare complications may include

A hole or weakness in the muscle wall in your lower back, where the structures behind the muscles wall push through (a hernia)
Wound infection
Worsening of the wound (wound breakdown)
Back pain that may need to be treated by a pain specialist
Issue related to your implant, for example scarring, infection and the implant turning over (rotating)

You can read more about possible problems with breast reconstruction on CancerHelp UK.