The OUTBACK Trial. Specific CRF Completion Guidelines

Transcription

1 The OUTBACK Trial A Phase III trial of adjuvant chemotherapy following chemoradiation as primary treatment for locally advanced cervical cancer compared to chemoradiation alone (ANZGOG 0902, GOG 0274, RTOG 1174) Specific CRF Completion Guidelines 1

2 Contents Where can I find explanations/help regarding data entry?... 3 General Note... 4 Baseline Visit... 5 Cancer Australia Form For Australian Sites only... 5 Nodal Assessment MRI Form... 5 RECIST Form... 5 Chemotherapy Visits... 6 Patient Data Form... 6 Toxicity Assessments... 6 Toxicity Form... 6 Serious Adverse Events... 7 SAE Form... 7 End of Treatment Visit... 7 End of Treatment (EOT) Form... 7 Follow up Visits... 7 Patient & Disease Status Form... 7 Nodal Assessment Follow up PET Form... 9 Quality of Life Visits... 9 Date form... 9 QOL Yes/No form... 9 QOL Non completion form

3 Where can I find explanations/help regarding data entry? InForm database 1) Orange text on the ecrf explains about information to be entered, or actions to be taken before proceeding. 2) Text that is underlined on the ecrf can be clicked on, which will bring up the Helptext window. Here you can find more information about a certain item on the ecrf. Study handbook Section 7 contains general information for data collection and entry. Section 8 contains information for SAE reporting. Specific CRF completion guidelines Please see below comments for some of the forms in the trial database. This document will be reviewed and updated periodically. OUTBACK trial coordinator Please the trial coordinator (outback@ctc.usy.edu.au) or give them a call to discuss any questions. Trial Newsletter The trial newsletters contain answers to frequently asked questions, items with high query rates and general information on data management. 3

4 General Note Do not leave fields blank, unless instructed to do so in these guidelines. If no data is available for given field, please explain the reason in a comment (speech bubble icon). You can type the comment in the textbox, or select one of the following options: Unknown when information is unobtainable Not Done if measure has not been taken or test has not been performed Not Applicable if measure was not due to be taken at the time of ecrf completion 4

5 Baseline Visit Cancer Australia Form For Australian Sites only If the participant only speaks English at home, please click on the speech bubble next to the item titled Main language, other than English, spoken at home and select Not applicable in the comments section Nodal Assessment MRI Form In order to enter nodal involvement, click on Add entry as shown below Repeat the procedure for all locations of involved nodes (left pelvic, right pelvic, left common iliac, right common iliac) RECIST Form RECIST (BL) visit: please enter the baseline RECIST assessment here RECIST visit: please enter the follow up RECIST assessment(s) here The lesions entered into the RECIST Baseline form are automatically copied over into the RECIST follow up form If more than one assessment method was performed for a single assessment, e.g. a CT scan and MRI were performed, click on Add entry as shown below Repeat the procedure for all the assessment procedures used Example: Three assessment methods were used Enter the first method in the assessment section. Click on Add entry to enter the second method. Click on Add entry again to enter the third method 5

6 Follow up RECIST visit: If more than 1 follow up RECIST assessment has been done, click on the New button at the bottom left of the screen to enter a new RECIST assessment Chemotherapy Visits Patient Data Form A date is required (Item 1) in order to trigger the remainder of the forms for the chemotherapy visits Please enter the date of assessment (prior to cycle treatment) as the date in Item 1. (The date of treatment administration will be entered on the actual chemo form) Toxicity Assessments Toxicity Form No baseline toxicity assessment needs to be entered Toxicities during the treatment phase are assessed retrospectively Example: The toxicities for Cisplatin chemo cycle 1 are assessed just prior to Cisplatin chemo cycle 2. So the date of the toxicity assessment for a given cycle will be after the date of treatment administration in that cycle Please record all toxicities present during a given assessment period (include both radiation and chemotherapy toxicities on the same form) Assessment of relatedness of toxicity to the study treatment: please make a combined assessment for radiation and chemotherapy toxicities (as applicable) Toxicities need to be reported for as long as they are present, even if they do not change in severity Example: Nausea Grade 2 was present during Adjuvant chemo cycle 2 and is still present as Grade 2 during Adjuvant chemo cycle 3 Nausea needs to be recorded on the toxicity forms for both Adjuvant chemo cycle 2 and 3 All SAEs need to be recorded as toxicities on the toxicity form for the relevant cycle throughout the duration of the SAE 6

7 Serious Adverse Events SAE Form The SAE form is embedded in the treatment visits Additional SAE forms can be triggered by clicking on the New button at the top right of the Summary View screen Please consult the protocol for events that are not considered as SAEs on the study Refer to the Study Handbook (Section 8) for more information on how to report SAEs (initial and follow up reports) All SAEs must be reported as ongoing until the underlying toxicities are completely resolved (i.e. grade 0 or back to baseline levels) Example: A patient was hospitalised with abdominal pain grade 3. At discharge, the abdominal pain had improved to grade 1. Even though the patient was discharged, the SAE was still continuing because the abdominal pain had not yet resolved to grade 0. End of Treatment Visit End of Treatment (EOT) Form Date of cessation of all study treatment is the last day of study treatment. o For patients in Arm A (Chemoradiation only) this is last day of radiation treatment (usually last day of brachytherapy administration) o For patients in Arm B (chemoradiation + adjuvant chemotherapy) this is the last day of adjuvant chemotherapy administration Toxicities that are assessed during the EOT appointment are captured in the last cycle of chemotherapy that the patient received. o For patients in Arm A, the toxicities from the EOT assessment are recorded in the Cisplatin cycle 5 visit o For patients in Arm A, the toxicities from the EOT assessment are recorded in the Adjuvant Chemo cycle 4 visit. Follow up Visits Patient & Disease Status Form The first follow up CRF is required at 6 month post randomisation A date is required (Item 1) in order to trigger the remainder of the forms for the follow up visits Please enter the date of the follow up assessment as the date in Item 1, and then click the Submit button prior to completing the rest of the form 7

8 If the patient has started other anti cancer treatment, please record details by clicking on Add entry at the bottom of the screen The follow up visit is a repeating form. In order to enter additional follow up visits, click on the New button at the bottom left of the screen (see below) To navigate to existing follow up forms, use the drop down menu at the bottom left of the screen, next to the New button 8

9 Nodal Assessment Follow up PET Form If no PET scan was performed (e.g. PET not available at site), please enter a comment for the form to say why the scan has not been done In order to enter a form comment, please click on the speech bubble at the top right of the form, select Not Done and type the reason in the text box Quality of Life Visits Date Form Please enter the date of the baseline assessment to trigger the next form QOL Yes/No Form Please record whether the patient will be participating in the QOL questionnaires If the answer is Yes, an additional form will be triggered QOL Non completion Form This form is used to record QOL non completion information which previously was collected on a separate paper form If a patient who is participating in the QOL questionnaires, has not completed a QOL booklet for a given time point, click on the New button at the top right of the screen (see below), to specify the reason for non completion Every time a QOL booklet does NOT get completed, a new row needs to be entered, by clicking on the New button Note: If the patient has completed the QOL booklet as scheduled, there is no need to add a row to the QOL Non completion form. 9