A study looking at joint and muscle aches, pain and stiffness in women with breast cancer (JACS)

Please note this trial is no longer recruiting patients.

This study is looking at women’s experiences of joint aches, pain and stiffness in breast cancer to try to understand more about what causes this. Pain can be caused by the cancer (a ‘symptom’), or by treatment (a ‘side effect’). This study is looking at pain as a side effect of treatment.

We know from research that many women have joint aches, pain and stiffness after treatment for newly diagnosed breast cancer that hasn’t spread (‘primary’ breast cancer). Another study of women at breast clinics showed that those with breast cancer had more joint pain that those who did not. And that these problems may affect women’s daily activities. Sometimes they can be bad enough to make the person want to stop their treatment. But it is not yet clear which breast cancer treatment causes the aches and pains. Or how bad these aches and pains are, how long they last and how they affect people’s lives.

Researchers want to find out more about joint aches and pains after treatment for primary breast cancer. Although they can be caused by getting older or the change of life (menopause), there may be a link to breast cancer treatment. They will look at the experiences of women having chemotherapy or hormone therapy (or both) for primary breast cancer. And compare these to those of women with a very early type of breast cancer called ductal carcinoma in situ (DCIS). They hope their findings will help doctors provide information to patients when deciding on their treatment plan. And find ways of treating the aches and pains. The aims of this study include finding out about

The history of many women’s joint aches, pains and stiffness
How these affect quality of life and daily activities
If the type of breast cancer and treatment makes a difference

Recruitment

Start 27/01/2010

End 31/12/2011

Phase

Other

Who can enter

You can enter this study if you are a woman and you

Have ductal carcinoma in situ (DCIS) or early breast cancer
Have been diagnosed and are having treatment at either Southampton General Hospital, Queen Alexandra Hospital Cosham or Winchester and Eastleigh Healthcare NHS Trust
Have just had surgery for breast cancer, and are going to have chemotherapy or hormone therapy after breast cancer surgery
Are able to understand and write clearly in English
Are at least 18 years of age

You cannot enter this study if your cancer has spread to another part of your body (metastatic breast cancer).

Trial design

This study will recruit 50 women with DCIS into one group, and 450 women with early breast cancer into another. If you have early breast cancer, you will then be put into one of several further groups, depending on your treatment plan. All these groups simply help separate the results for the researchers.

Everyone will fill out a set of questionnaires 5 times over 2 years. They will ask you about

Your background, for example your age and where you live
Your quality of life
Any joint pain you have
Any other medical conditions you have

You return the questionnaires each time in the stamped addressed envelope provided by the study team.

The study team will also ask if you would be willing to be interviewed in a possible future study looking at women’s experiences of living with joint pain linked to breast cancer.

If you are under the care of Southampton General Hospital, the team might also ask if you would be willing to give some blood samples to be stored for future studies. Researchers would use these to look into possible causes of breast cancer related joint aches and pains. If you agree, you will give up to 4 teaspoons of blood at the start of the study.

If you agree, the team will monitor how you are getting on by contacting the Cancer Registry, which holds basic information about everyone with cancer in the UK.

Hospital visits

You fill out your questionnaires at home and return them by post. And you will give any blood samples for the study at your routine hospital appointments. So you will not make any extra hospital visits to take part.

Side effects

As there are no treatments in this study, there are no side effects. But you may find it difficult to talk or write about your experiences. If there are any questions you prefer not to answer, that is fine. If you need further support for anything raised by this study, the research team can help you find this.