Consent forms for SACT (Systemic Anti-Cancer Therapy)
6th February: Generic SACT form reviewed and updated, Immunotherapy generic form and breast forms to follow soon
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 group’s forms are available and when will they be reviewed?
The regimen-specific forms have been published for the following tumour site groups.
Each group of forms will be reviewed on a rolling schedule. The process by which each group of forms is revalidated may result in the republication dates exceeding the date of review indicated on each group of forms. All forms are valid until new versions are made available.
|Tumour site||Issue date||Review date|
|Head & Neck||Aug-16||Aug-19|
|Generic consent form||Sep-16||Sep-19|
|Skin - Melanoma||Nov-16||Nov-19|
|Generic Immunotherapies form||Dec-16||Dec-19|
|Upper GI - OG & GIST||Aug-17||Aug-20|
|Upper GI - HPB||Aug-17||Aug-20|
|Urology - Germ cell||Sep-17||Sep-20|
|Urology - Prostate||Oct-17||Oct-20|
|Chronic Myeloid Leukaemia (CML)||Feb-18||Feb-21|
|Brain & CNS||Mar-18||Mar-21|
|Urology - Renal cell & Small cell||Jul-18||Jul-21|
|Skin - Non-Melanoma||Nov-18||Nov-21|
|Neuroendocrine & Adrenal||Jan-19||Jan-22|
|Chronic Lymphocytic Leukaemia (CLL)||Jun-19||Jun-22|
|Myeloproliferative neoplasms (MPN)||Jun-19||Jun-22|
|Acute Myeloid Leukaemia (AML)|
|Acute Lymphoblastic Leukaemia (ALL)|
|Sarcoma (Bone and Soft Tissue)|
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 us the generic form where a regimen-specific form does not exist.
When will the consent forms for the haematology tumour groups be available?
CML, CLL, MPN consent forms have now been published. The other haematology sub-groups will follow.
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 UK 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. Please refer to the “Guidance on consent for SACT” on this website.
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.”
The consent forms are developed to ensure a high level of consistency in the information giving and discussion with the patient. Your Trust Governance and/or consent committee must agree before you use these forms.
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, or a scanned copy in the patient’s electronic records.
Are there plans for the forms to be made available in Welsh and/or other languages?
The generic SACT and generic immunotherapy consent forms have been translated to Welsh. There are plans to translate and provide the generic forms in other ethnic languages (Polish, Guajarati). 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 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: 20 December 2018
Last updated: 20 December 2018
Last updated: 15 Setpember 2019
Last updated: 19 December 2017
Last updated: 21 May 2018
The published forms listed here are not exhaustive for neuroendocrine cancers. They reflect mostly (but not exclusively) those regimens for gastroenteropancreatic neuroendocrine tumours.
The regimen-specific consent forms for neuroendocrine cancers of other areas of the body can be found within their respective anatomical groups.
Last updated: 15 February 2019
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.
We’re now on twitter.
SACT form update
SACT consent forms are currently being reviewed on a rolling schedule. Please see FAQs for order of roll-out. Republication dates may exceed the date of review indicated on each form. All forms are valid until new versions are available.