Consent forms for SACT (Systemic Anti-Cancer Therapy)
8 September 2018: Urology-Small cell cancer SACT forms & Urology-Renal cell cancer SACT forms
18 September 2018: Niraparib SACT form for Gynaecological cancer
Are you a clinician or other healthcare professional involved with consenting and treating patients with Systemic Anti-Cancer Therapy (SACT)?
We are working with Guy’s and St. Thomas’ NHS Foundation Trust to produce national standardised SACT regimen-specific consent forms.
Endorsed by the UK Chemotherapy Board, we want to support clinicians in ensuring all patients are fully informed when consenting to SACT.
The UK Chemotherapy Board has also issued guidance for the introduction of the national SACT regimen-specific forms by individual chemotherapy providers.
The consent forms and guidance document are available to download in PDF format. Forms are grouped by tumour-site.
Which tumour site groups are forms available for?
The regimen-specific forms are being published in tumour site groups, on a rolling schedule. The order of roll-out is as follows:
|Tumour site||Publication date|
|Generic consent form||July 2016|
|Head & Neck||October 2016|
|Skin - Melanoma||November 2016|
|Immunotherapies generic form||December 2016|
|Supportive meds||April 2017|
|Upper GI - OG & GIST||October 2017|
|Upper GI - HPB||December 2017|
|Urology - Prostate||December 2017|
|Urology - Germ cell||April 2018|
|Haematology CML||May 2018|
|Brain & CNS|
|Upper GI - Neuroendocrine|
|Urology - Renal cell (9) & Small cell (2)|
|Skin - Non-Melanoma|
|Myeloproliferative neoplasms (MPN)|
|Chronic lymphocytic leukaemia (CLL)|
|Acute myeloid leukaemia (AML)|
|Acute lymphoblastic leukaemia (ALL)|
Please check the website regularly (e.g. once a month) for new forms and updates.
What should I do if I cannot find the regimen-specific form I need?
We would encourage Trusts to use the generic form where a regimen-specific form does not exist.
When will the consent forms for the haematology tumour groups be available?
CML consent forms have now been published. The other haematology sub-groups will follow.
What should I do if I am experiencing problems accessing the forms on the website?
If you can’t open the accordions or download the forms it’s usually because of the browser or the computer settings. If it’s the browser it’s often due to a corruption or long session so closing the browser and opening a new one and trying again should fix it. If not, try re-booting to clear the memory and trying again. If you’re still experiencing problems contact your IT team to check your settings aren’t preventing downloads. The forms are PDFs so you will need Adobe Acrobat to read them. If you don’t have this you should be prompted to download it when you try to open a form. Check with your IT team if you have problems viewing the downloaded forms.
How have the forms been developed and what is the governance process?
The forms are based on the Department of Health consent form 1. The template form has been approved by the National Chemotherapy Board. Each hospital/Trust will need to ensure that the forms are approved for use locally by their governance or consent committee, whichever is most appropriate for the individual organisation.
The consent forms and the legal process
The consent form is not a legal document but it represents best practice and conforms with and complements the guidance documents available to clinicians taking consent. Several guidance documents have described best practice in the area of consent with respect to law, ethics, training and experience required and the need for documentation that consent has taken place.
We explored informal counsel with a medico-legal advisor, in response to the issue of the Montgomery judgement. The following has been taken from their reply:
The Montgomery judgement really only brings the legal situation in the claims process into line with what doctors have been obliged to do since this GMC guidance was issued in 2008.
The most important aspect of the GMC guidance is that information about risk must be individualised for that patient. So for example, risk of cardiac events may be higher in a patient with pre-existing cardiac disease, or peripheral neuropathy may be more relevant if you are a concert pianist, as opposed to a patient who is not.
These are probably the most comprehensive and patient friendly consent forms I have seen.”
How do I give a copy of the completed form to the patient?
The patient can be given a photocopy of the completed form. We recommend retaining the original form in the patient’s records.
Would it be possible to add information on extravasation to all intravenous cytotoxic therapies?
In response to a survey conducted across Lead cancer clinicians England and UKONs members, we will be incorporating information as to the risk of extravasation in all intravenous chemotherapy regimens (vesicants, irritants and neutrals). This will not apply to immunotherapy drugs.
Are there plans for the forms to be made available in Welsh?
We are liaising with NHS colleagues in Wales regards translation of the forms into the Welsh. We plan to translate the generic consent forms. Please check the website for these forms and updates.
Are there any plans to develop chemo-radiotherapy consent forms?
These forms are designed specifically for taking consent for SACT. For instances where the SACT is given in combination with radiotherapy, the radiation therapy will need to be consented for separately. We do not currently plan to develop chemo-radiotherapy consent forms.
Are there plans for the forms to be made available for paediatrics, sarcoma and TYA groups?
We plan to develop national SACT regimen-specific consent forms for these patient groups.
Are there plans for the forms to be made available electronically?
We are currently exploring the feasibility of editable electronic consent forms with Cancer Research UK.
Where can I find more information about the regimen-specific consent forms?
Last updated: 11 April 2018
Last updated: 12 May 2017
Last updated: 18 September 2018
Last updated: 19 December 2017
Last updated: 21 May 2018
Who has approved the content in these forms?
The programme is being led by a dedicated CRUK-funded oncology pharmacist at Guys’ and St. Thomas’ NHS Foundation Trust.
All forms are independently checked by an oncology/haematology pharmacist, oncology/haematology consultant and member of the UK Chemotherapy Board.
Publishing, additions and updates
We are publishing forms by tumour site, the first were for breast cancer in May 2016. We will publish new forms for other tumour sites regularly.
Recent additions and updates will be highlighted on the "What's new?" section on this page, and details of when forms have been last updated is stated in each section. Please check for updated versions and ensure that you use the latest version of each form.
SACT form update
In October 2018, NHS England issued a letter highlighting the importance of informing patients about the rare but life threatening side effect of severe skin reactions. National SACT consent forms that include capecitabine will be updated to reflect this advice as soon as possible.