Cycle

This section provides additional information about the cycle itself.

Notes:

• the cycle number and start date of cycle are mandatory fields within this section
  • obtaining the weight may not always be possible or appropriate
  • we would expect to receive as much information within this section as possible, as these provide valuable information on the patient’s suitability for further treatment
• where patients are part way through their programme, regimen or even cycles, simply record the data for activity in the relevant month
• overtime, we would expect to build a picture of full treatments for each patient, but initially we expect to receive partial data

May be multiple occurrence per submission (0..*)

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

End of Section - Cycle Modification

Start of Section - Cycle Delay (0..1)

End of Section - Cycle Delay

Cycle Number

The ‘Cycle Number’ refers to the cycles numbered sequentially within each regimen.

Note:

• this data item is mandatory in v4.0, previously ‘Required’

Start Date of Cycle

This is a mandatory data item. The ‘Start Date of Cycle’ is the date of the first drug administration in each cycle.

Notes:

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

Weight at Start of Cycle

The ‘Weight at Start of Cycle’ is the weight measured in kilograms at the start of the cycle.

Performance Status at Start of Cycle – Adult

The ‘Performance Status at Start of Cycle – 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

Cycle Modification Section

These grouped data items form a section, which identifies if a cycle 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

Cycle Modification

This is a new data item in v4. Record if any drugs have been omitted from this cycle.

Note:

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

Reason For Cycle Modification

This is a new data item in v4. Record the reason if any drugs have been omitted from this cycle. 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 cycle

Reason For Cycle Modification - Patient (Clinical) Factors

This is a new data item in v4. Record the clinical factors which resulted in modifying the cycle.

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 cycle
• 3 - Comorbidities, identifies that the patient’s comorbidities were a factor in modifying the cycle
• 8 - Other, identifies other reasons that were a factor in modifying the cycle

Toxicity Grade (Cycle 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 Cycle Modification’
• this data item must only be selected if ‘4- Toxicity’ is selected in ‘Reason for Cycle Modification’

Cycle Delay Section

These grouped data items form a section, which identifies if a cycle has been delayed.

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

Cycle Delay

This is a new data item in v4. Record if the cycle has been delayed.

Note:

• if you are recording a cycle delay, this data item becomes mandatory within the section

Reason For Cycle Delay

This is a new data item in v4. Record the reason for the cycle delay. 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 delaying the cycle

Reason For Cycle Delay - Patient (Clinical) Factors

This is a new data item in v4. Record the clinical factors which resulted in the cycle delay.

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

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 delaying the cycle
• 3 - Comorbidities, identifies that the patient’s comorbidities were a factor in delaying the cycle
• 8 - Other, identifies other reasons that were a factor in delaying the cycle

Toxicity Grade (Cycle Delay)

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 ‘Cycle Delay’
• this data item must only be selected if ‘4- Toxicity’ is selected in ‘Reason for Cycle Delay’