CRUK National SACT Breast Cancer Consent Forms

The consent form project team is very pleased to announce that the national breast consent forms are now available on the CRUK website at : www.cruk.org/sact_consent.

In collaboration with Anne Armstrong, the breast clinical lead for regimen-specific national SACT consent form, the breast forms have been reviewed and many changes have been made. There are now 52 forms in total. 17 new ones added and 2 archived.

Many of the new forms contain a combination of drugs so that only one consent form needs to be completed.

The breast forms have been updated on the revised version of the template agreed by the national steering group. For your information we have summarised the core changes below made to the forms.

The points below is a summary of generic changes made to ALL the breast forms:

• Footer note included on all 5 pages to reflect the name of the regimen
• Information about temperature moved to the top (to highlight the importance of temperature monitoring) in the majority
• A section on growth factors has been added to some of the regimens where this is standard practice (in some there is not enough room to add)
• Side-effects of anti-emetics has also been added
• The statement ‘ Early menopause can cause symptoms such as hot flushes, vaginal dryness’ added to the standard menopause statements under other risks.
• The last standard statement about life threatening complications under other risks has been rephrased.
• Additional information in risks and information section (Page 3)
• A section on compliance with clinical management guideline/protocol added to page 3.
• Link to the CRUK SACT treatment record added on page 3
• Link referring to the Scottish legal framework included on page 5.

The points below are the changes made to the individual regimen specific consent forms:

• Capecitabine
Standard statement added – There is a risk of potentially life threatening side effects if your genetic make –up is such that you cannot break down capecitabine properly. This is called DPD deficiency. Please contact your hospital straight away if you get minor side effects in your first cycle of treatment

• All regimens containing docetaxel, standard statement added for GCSF under other risks
If growth factors are prescribed following chemotherapy to maintain number of white cells to prevent infection, you may experience bone pain, headaches, red and itchy skin around the injection site

• EC – T and T-EC consolidated into one form where the appropriate scheduling can be selected. In other regimens where suitable, option for alternative scheduling outlined.

• Where suitable adjuvant chemotherapy updated to every 14 or 21 days

• Everolimus
Added to common: Reduced immune infection can lead to the development of infections. Viral infections, including hepatitis B (HBV) may be reactivated during or after treatment.

• For palbociclib, ribociclib and abemaciclib , names of the aromatase inhibitors included.
Following a recent safety announcement by the FDA, standard statement added to both – Changes in lung tissue may lead to a cough, chest pain and breathlessness. Let your doctor know if you have difficulty breathing or experience shortness of breath while at rest or gentle activity.

• Abemaciclib
Fertililty changed from 1 month to 6 months

• For gemcitabine regimens, standard statement added – Very rare side effects include problems with your heart, changes in blood pressure, posterior reversible encephalopathy syndrome (PRES), capillary leak syndrome and haemolytic uraemic syndrome (HUS). HUS is a condition that destroys cells which help with clotting, causing anaemia and kidney failure.

• Taxane regimens – ‘Occasionally hair loss may be permanent and nail loss temporary’ has been added to the section of other risks.

Overall, we have tried to keep the phrases and side-effects consistent across all the regimens, although sometimes this was not possible due to lack of space.
Due to a number of challenges the breast forms took much longer that we anticipated.

A huge thank you to Anne Armstrong and the pharmacists at Guy’s for all their hard work – it was an enormous task.

Any questions please do not hesitate to contact Alia.

With best wishes,
Alia and Janine

Alia Nizam – CRUK Specialist Oncology Pharmacist
Janine Mansi – Clinical Lead for national regimen-specific consent forms