SACT – Regimen

This section provides additional information about the regimen itself.

May be up to one occurrences per submission (0..1)

Line of Treatment Choice - Choice 1..1

Choice 1 - Curative line of treatment

End of Choice 1

Choice 2 - Non-Curative line of treatment

End of Choice 2

End Of Line of Treatment Choice

Start of Section - Regimen Modification (0..1)

End of Section - Regimen Modification

The following data items have been removed from SACT v4:

• 49 – Adjunctive Therapy
  • this has been replaced with ‘Treatment Context’
• 20 – Co-Morbidity Adjustment
  • replaced with option in new Dose modification section

Treatment Context

The ‘Treatment Context’ is a new data item. Treatment context is the context in which the SACT is prescribed, in relation to other treatments the patient has or may receive:

• Neoadjuvant (Before the main therapy)
• Adjuvant (After the main therapy)
• SACT Only, if the treatment has no other element
• CTYA only, where both Neoadjuvant and Adjuvant are applicable

Note:

• this data item replaced ‘Adjuvant Therapy’, as this better reflects current clinical practice

Intent of Treatment

The ‘Intent of Treatment’ data item has been updated to simplify data recording and reduce burden for front line staff collecting and reporting the data.

Notes:

• this data item is no longer a repeating data item and is ‘Required’ in v4.0
• 01, 02, 03, 04, 05, 98 and 99 have been retired in v4.0
• 06 and 07 are new attributes from v4.0

Line of Treatment Choice

The following two data items form a choice where either the curative or non-curative line of treatment can be recorded. This is a Mandatory [1..1] section, therefore one or the other must be selected depending on the treatment being delivered within this regimen.

Note:

• there can be up-to 99 lines of treatment for either the curative or non-curative treatment, therefore they have a defined range of 1-99

Choice 1:

Curative Line of Treatment

The ‘Curative Line of Treatment’ is a new data item in v4. This is to record the line of “curative” treatment.

Notes:

• curative line of treatment is a Regimen of SACT defined upfront and given with curative intent
  • curative intent refers to therapy aimed at elimination of cancer and preventing its recurrence

Choice 2

Non-Curative Line of Treatment

The ‘Non-Curative Line of Treatment’ is a new data item in v4. This is to record the line of “non-curative” treatment.

Notes:

• non-curative line of treatment is a regimen of SACT defined upfront and given with non-curative intent
  • non-curative intent refers to therapy aimed at maintaining or improving the quality and/or the quantity of life (for example, inducing “remission”) but without the expectation of cure

Regimen

This is a mandatory data item. The ‘Regimen’ is the acronym derived from the drugs used to identify the Anti-Cancer Drug Regimen.

Notes:

• SACT does not require Trusts to change existing practice or change local regimen names
  • regimen names must refer to a single identifiable regimen, therefore ‘bucket codes’ must not be used
    • a bucket code is a code that refers to more than 1 regimen, for example ‘Chemotherapy’
• once uploaded, local regimen names need to be mapped to a national standard list
  • this is a quick and easy process and can be done via the SACT online mapping tool, pharmacists are usually the best people to do this
    • this is available via the online portal for registered users
• the SACT portal data checker will accept any text that is used in the Regimen column, on upload, all regimen names are checked to the OPCS+ list included on the portal
  • this list is a version of the OPCS Chemotherapy Regimen List, as updated by SACT pharmacists to include new regimens, trials etc
  • if your local name for a particular regimen exactly matches the OPCS+ list, it will be automatically mapped via the portal
• if the regimen name (as it appears on the mapping tool) is truncated or unclear, please contact SACT
• regimens are mapped by Trust, so those uploaded by all the hospitals within your Trust will appear together
  • it may require pharmacists from all hospitals within the Trust to work together to complete all the mapping

Height at Start of Regimen

The ‘Height at Start of Regimen’ is the height measured in metres at the start of the regimen.

Notes:

• a value of 136cm, must be submitted as 1.36
• local QA should be implemented to ensure any value over 2 metres are reviewed prior to upload

Weight at Start of Regimen

The ‘Weight at Start of Regimen’ is the weight measured in kilograms at the start of the regimen.

Note:

• height and weight can be used by NDRS to calculate the patients BMI

Performance Status at Start of Regimen – Adult

The ‘Performance Status at Start of Regimen – Adult’ is the World Health Organisation (WHO) classification indicating a person’s status relating to activity/disability.

Notes:

• this data item is not applicable for Paediatric patients or Skin diagnoses, except for melanoma stage 4

• if a patient is on high dose steroid therapy (for example, dexamethasone), which is clinically considered to have artificially and temporarily improved the patient’s performance status, the performance status assessed prior to commencing on steroids should be recorded

Decision to Treat Date

The ‘Decision to Treat Date’ is the date that the consultation between the patient and the clinician took place and a planned cancer treatment was agreed.

Notes:

• all date formats must be ccyy-mm-dd
• SACT will not recognise or accept American date formats

Start Date of Regimen

This is a mandatory data item. The ‘Start Date of Regimen’ is the first administration date of the first cycle of a regimen.

Notes:

• all date formats must be ccyy-mm-dd
• SACT will not recognise or accept American date formats

Clinical Trial

The ‘Clinical Trial’ enables the recording of when a patient is currently in an active SACT trial.

Chemoradiation

This is a new data item in v4. An indication of whether the Systemic Anti-Cancer Therapy Drug Regimen was given as part of Chemoradiation.

Note:

• this data item has been restored from v2 following clinical review, to include its original data item number [24]

Regimen Modification Section

These grouped data items form a section, which identifies if a regimen modification was made.

This is a Required [0..1] section, however the data is important and where applicable must be selected as follows:

• if ‘No’ is selected, then no further data is required
• if ‘Yes’ is selected, then additional questions will be asked, and in some cases additional linked data items may also be valid and needs answering:
  • these additional questions are important, and validations will be used as you upload your data onto the NDRS API
  • these are required to improve and enforce data quality and prevent illogical data returns
  • it is important that you implement processes to ensure your data is correct

Regimen Modification

This is a new data item in v4. Record if there has been an upfront dose modification, which modified the regimen.

Note:

• if you are recording a regimen modification, this data item becomes mandatory within the section

Reason For Regimen Modification

This is a new data item in v4. Record the reason for upfront dose modification. More than one option can be selected, where appropriate.

Notes:

• 2 - Organisational (Trust) Issues, is where a modification was due to organisational issue such as protocol, capacity, IT & infrastructure
• 3 – Patient (Clinical) Factors, is where a modification was due to Genomics e.g. DPYD variant, Frailty, Comorbidities or Other
• 4 - Toxicity, identifies that toxicity arising from the patient’s regimen was a factor in modifying the dose and/or schedule of their regimen

Reason For Regimen Modification - Patient (Clinical) Factors

This is a new data item in v4. Record the clinical factors which resulted in a dose modification.

More than one option can be selected, where appropriate, but can only be selected if ‘3-Patient (Clinical) factors’ is selected in ‘Reason for Modification’

Notes:

• 1 - Genomics e.g. DPYD variant, is the gene encoding the Dihydropyrimidine Dehydrogenase (DPD) enzyme that affects how bodies break down fluorouracil and capecitabine derived chemotherapy drugs
• 2 - Frailty, identifies that the patient’s frailty was a factor in modifying the dose and/or schedule of their regimen
• 3 - Comorbidities, identifies that the patient’s comorbidities were a factor in modifying the dose and/or schedule of their regimen
• 8 - Other, identifies other reasons that were a factor in modifying the dose and/or schedule of their regimen

Toxicity Grade (Regimen Modification)

This is a new data item in v4. Record toxicity score/rating using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

Notes:

• only one grade can be selected, per ‘Reason for Regimen Modification’
• this data item must only be selected if ‘4- Toxicity’ is selected in ‘Reason for Modification’