A trial comparing how women feel about themselves after having immediate or delayed breast reconstruction surgery (QUEST B)

This trial is comparing women’s feelings after having one of 2 timings of surgery to make a new breast shape (breast reconstruction) after having a breast removed (mastectomy).

If you have surgery to remove a breast affected by cancer (mastectomy), you can have a new breast shape formed by the surgeon. This is called breast reconstruction. You can either have this at the same time as your mastectomy (immediate reconstruction), or later on, normally after you have finished other breast cancer treatments (stage delayed reconstruction). You would usually have stage delayed reconstruction in 2 stages. The first stage is during your mastectomy, where the surgeon puts a temporary implant under your breast skin, to stretch the skin. You later have further surgery to create a new breast shape.

We already know that both immediate and stage delayed reconstruction give good cosmetic results. But researchers want to find out if the different timings of surgery affect women’s well being, satisfaction with the procedure, 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 the differences between immediate and delayed reconstruction and help them make an informed decision.

You will not have any direct benefit from taking part in this trial, and it is unlikely to change your treatment plan in any way. The results of the trial 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 may be able to enter this trial if

You have invasive breast cancer or ductal carcinoma in situ (DCIS)
You need to have your affected breast removed (mastectomy), and are fit enough to have this operation
You have chosen to have latissimus dorsi breast reconstruction (LDBR)
You would be suitable to have this surgery some time after your mastectomy
You do not mind whether your reconstruction is at the same time as your mastectomy, or some time afterwards
Your doctor has said that you will need radiotherapy after your mastectomy
You 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 already had radiotherapy to the breast
Have cancer in both breasts
Have breast cancer that has come back after treatment
Have had surgery just to remove the cancer from your breast (wide local excision or lumpectomy), and you now need a mastectomy to complete this 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
Are pregnant
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.

This trial 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.

Everyone taking part will have a type of breast reconstruction called latissimus dorsi breast reconstruction (LDBR).

If you are in group 1, you will have your breast reconstruction at the same time as your mastectomy. After this, you will have the radiotherapy already planned for you.

If you are in group 2, you will have stage delayed breast reconstruction, with a temporary implant (expander) inserted at the time you have your mastectomy. This is to stretch the breast skin. You then have the radiotherapy already planned for you. After your treatment is finished, you will have the second stage of the breast reconstruction.

Your surgeon and nurse will talk to you more about what your particular surgery will involve.

If you are due to have chemotherapy, you will have this before your radiotherapy. This is not part of this trial.

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 complete the first booklet before you know which timing of reconstruction you are going have. Then, if you are happy to carry on in the trial, the trial team will send you the same booklet to fill out at home at

3, 6, 9, 12, 15 and 18 months after your mastectomy
2, 3, 4 and 5 years after your mastectomy

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 the trial, the team will also ask everyone 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 B, how they feel about making the decision and their experiences if they took part. The team will ask you to

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

Hospital visits

You and your surgeon will have already agreed that latissimus dorsi breast reconstruction is the best option for you, and that you are suitable for either immediate or stage delayed reconstruction.

By taking part in this trial, you will not be able to decide whether you have immediate or stage delayed reconstruction. If you are in group 2, you will need

1 to 2 extra visits after your temporary implant (expander) is inserted
About 2 extra follow up visits after your 2nd operation

Side effects

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

Taking part in this trial will not increase the risk of complications you may have from a latissimus dorsi breast reconstruction. Complications of latissimus dorsi breast reconstruction include

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 muscle 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

As well as these complications, if you are in the group having delayed reconstruction you may have

A feeling of tightness as the stretching implant (expander) is inflated with salt water (saline)
The risk of the expander implant moving upwards out of position if it is not put low enough during your surgery
Infection of the expander implant

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