A study looking at improving outcomes and quality of life for older women with breast cancer

Cancer type:

Breast cancer

Status:

Results

Phase:

Other

This study used decision making tools to improve treatment outcomes and quality of life for women aged 70 or older with breast cancer. 

The study was open for people to join between 2013 and 2018. The team published the results between 2015 and 2022.

More about this trial

Doctors can treat breast cancer with surgery, radiotherapy, hormone therapy or a combination of these. They depend on research to make sure that every woman gets the treatment that suits her best.

Much of this research was in women under the age of 70. This meant that doctors had much less evidence to guide them about treatments for women over the age of 70. 

In this study researchers developed tools to help older women and their doctors make decisions about breast cancer treatment. These decision making tools were:

  • a web page doctors can use during the clinic appointment
  • detailed written information about 2 treatment options for the women
  • 2 tables summarising the pros and cons of the 2 treatment options

After developing the tools, the team assessed them in breast clinics in 46 hospitals. 

In some of the hospitals the women and their doctors had training in how to use the tools. In the remaining hospitals the doctors and women decided about treatment in the usual way. 

The main aims of this study were to:

  • gather detailed information about the treatment of breast cancer in older women
  • find out how well older women do after treatment
  • find out how well the decision making tools work
  • find out how many women and doctors use the decision making tools

Summary of results

In this cohort study 3,416 women took part. 

Developing the decision making tool
To develop the decision making tool the team looked at the different treatments these women had and compared the outcomes. They followed the women up 2 years after their treatment.

Surgery for older women with early stage breast cancer
In this group there were 2,816 women. They found that there were no deaths as a result of the surgery. There were 551 unwanted medical events recorded after surgery. The majority of these were simple complications with their wounds. For a small number of women, their unwanted medical event was serious. They spent time in hospital. These serious events included:

  • heart problems
  • breathing problems 
  • blood clots in the brain

The team looked at how the surgery affected the women’s quality of life. They found that within the 6 weeks after surgery their quality of life was moderately affected. This was only for a short time. For some women, their quality of life was still affected 2 years later. 

Women who had their breast and lymph nodes Open a glossary item from their arm pit removed reported the worst effect on their quality of life. In the long term their daily activities were somewhat impacted. 

The team concluded that surgery was generally safe and well tolerated. There is a impact on the quality of life for women who had their breast and lymph nodes removed. These risks of surgery need to be discussed with women using a shared decision making tool. 

Surgery followed by hormone therapy compared with hormone therapy only
In this group there were 2,845 women:

  • 500 women had hormone therapy only
  • 2,345 women had surgery followed by hormone therapy

The team looked at how many women were alive after treatment. They found that the women who had surgery followed by hormone therapy lived longer. 

They looked at whether it was the breast cancer that had affected how long people lived for. They found there was no difference between the two groups.  

When the team looked at their quality of life, they found that for women who:

  • had hormone therapy only, their quality of life was low at the start
  • had surgery, their quality of life got somewhat worse in the 6 weeks after surgery, but them largely returned to normal in most women

At 2 years the team found that for women who:

  • had surgery, their quality of life for the majority had returned to what it was before, but for some there were some permanent changes
  • had hormone therapy only, their quality of life slowly got worse over time as their health worsened with time. This was probably due to health problems they already had.

The team say that these effects on quality of life should be discussed with women when considering treatment.

Comparing chemotherapy after surgery to no chemotherapy after surgery
The women in this group had a high risk of their cancer coming back.

The team were able to look at the results of 1,495 women. Of these:

  • 371 women had chemotherapy
  • 1,124 women didn’t have chemotherapy

For most women the chemotherapy was given soon after surgery and usually lasted several months.

The team looked at how long the women lived after treatment. Those who had chemotherapy lived longer overall. But women who had been offered chemotherapy were younger and fitter than those who had not.

The team looked at the difference in age and fitness for women with oestrogen receptor positive Open a glossary item breast cancer. They found there was no benefit for them to having chemotherapy. For women with oestrogen receptor negative Open a glossary item cancers there was a benefit.

The team looked at the quality of life of those who had chemotherapy. They found that at 6 months after their cancer diagnosis, their quality of life had dropped significantly. But it had improved again by 18 months, and had returned to the level it was before starting chemotherapy.
 
The team looked at the chemotherapy side effects. They found that the most common one was an infection. One woman had died due to a heart problem which the chemotherapy may contributed to.
 
They also looked at how many women had trastuzumab with their chemotherapy. 144 women had trastuzumab. Trastuzumab can affect how the heart works. The team looked at how many women who had trastuzumab had heart problems. They found that:
  • 4 women had heart problems within 6 months 
  • 10 women had heart problems within 1 year

The team concluded that having chemotherapy after surgery affected the quality of life significantly for a few months. But there are some impacts on the women’s quality of life that do not always settle in the long term. These may include hair loss and tingling in the hands and feet. 

How cognitive changes affect treatment outcomes for older women with early breast cancer
As people age their ability to think, remember and concentrate can be affected. These are called cognitive changes. If these changes are severe, they can be called dementia.

For women who had dementia at the time of their cancer diagnosis the team wanted to find out whether it affected their treatment and its outcome. 

The team compared what treatment women without cognitive changes had to those who did have these changes. They found that for women with severe cognitive changes:

  • fewer had surgery followed by hormone therapy, and just had hormone tablets alone
  • fewer had treatment such as chemotherapy and radiotherapy after their initial treatment

At 2 years after treatment, the team found that more women who had severe cognitive changes (dementia) had died. And this was due to other health factors and not due to having breast cancer.

Testing the decision making tool (DESIs)
The DESIs consisted of:

  • a web page doctors can use during the clinic appointment
  • detailed written information about 2 treatment options for the women
  • 2 tables summarizing the pros and cons of the 2 treatment options

Across the UK 46 hospitals took part. In 21 hospitals, the doctors and women were given training on how to use the DESIs and used them to decide about treatment. In 25 hospitals, they decided about treatment in the usual way. 

The team looked at the difference in the quality of life between the women who used DESIs and those who didn’t. They did this:

  • before treatment
  • at 6 weeks 
  • at 6 months

They analysed these results based on whether the DESIs were used or not. The first analysis was based on whether they were treated at a hospital with access to the DESI or not. This was regardless of whether it was appropriate to use it or whether it was used or not. They found that there was no difference at either of these time points. 

The team also analysed these results based only on women with whom the tools were appropriate to use and were actually used. They found that there was a small but significant difference in their quality of life at 6 months. 

After 3 years of follow up the team looked at how many women were alive in each group. They found there was no difference between the groups. 

The team looked at the knowledge the women had about their treatment. This was for women who were offered either surgery followed by hormone therapy or hormone therapy only. They found that those who used DESIs had a better knowledge of their treatment options and treatment. 

As the DESIs improved the knowledge of the treatment, the team said that this suggested they improved the women’s informed consent Open a glossary item

The DESIs are now online. The website is called the Age Gap Decision tool

The team intend to further develop the DESIs to include quality of life and unwanted medical events (adverse events). 

Assessing the use of DESIs
The team interviewed 73 women and 10 healthcare professionals about using the DESIs. They found that the women and healthcare professionals thought they were very useful. The DESIs helped with shared decision making about treatment.

Differences in the treatment offered to older women with breast cancer
The team looked at the information recorded in 2 UK Cancer registries Open a glossary item. They also used the information from this study. They wanted to find out if older women with oestrogen receptor positive Open a glossary item breast cancer who could have surgery, did have surgery.

They found that there was considerable difference in the number of women who could have surgery and did have surgery. The team said this could be because doctors used different measures when they considered:

  • what other medical conditions the woman had
  • the size of the cancer and whether it had spread 
  • the physical condition of the woman
  • any changes in the woman’s thinking ability, memory and concentration

The team say this highlights the need for guidelines that doctors can use to assess the fitness of older women. 

Conclusion
The study team developed decision making tools that older women and their doctors can use to make a shared decision about treatment. After using these decision making tools both the women and doctors gave positive feedback. 

Women who used the tools said that it had increased their knowledge of their cancer and its treatment. Understanding more about the treatment and its impact affected the women’s choice of treatment. More women chose less full treatment options because of the impact it could have on their quality of life and their independence. 

There is now a website that doctors and the women can visit to find out more about the tool and how to use it. The website is called the Age Gap Decision tool

The team found that quality of life and independence is important for these women. So they are going to develop the Age Gap Decision tool further to include this. 

More detailed information
There is more information about this research in the reference below. 

Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.

Improving outcomes for women aged 70 years or above with early breast cancer: research programme including a cluster RCT
L Wyld and others
NIHR, National Institute for Health and Care Research Journals Library, 2022. Volume 10, issue 6, under the ‘Article Content’ tab.

Where this information comes from    
We have based this summary on the information in the article above. These have been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the links we list above are active and the articles are free and available to view.

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

Professor Lynda Wyld

Supported by

Cardiff University
Doncaster and Bassetlaw Hospitals NHS Foundation Trust
NIHR Clinical Research Network: Cancer
Sheffield Hallam University
Sheffield University

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

10794

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

Last reviewed:

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