S1316 – The Malignant Bowel Obstruction Study Forms and Procedures Katie Arnold, MS SWOG Statistical Center Seattle, WA 10/24/2014S1316 Training1

S1316 Presentation Outline Study timeline Study flow Eligibility and equipoise Randomization (or not) Endpoint and hospitalizations Documenting MBO Treatment Active vs. passive follow-up 10/24/2014S1316 Training2

S1316 General Study Timeline Patient hospitalized with MBO Registration and randomization Patient discharged from hospital Weeks 1 – 13: Weekly calls from site Weeks 17 – 53: Calls every 4 weeks from site Study participation complete 10/24/2014S1316 Training3

Patient Hospitalized with MBO Eligibility Equipoise Informed consent Patient chooses treatment assignment –Randomization (surgery vs. not) –Surgery –No surgery 10/24/2014S1316 Training4

S1316 Registration and Randomization Register Randomize (if patient selected randomization) Complete patient contact form for site Complete and patient contact form for dietary recalls Obtain baseline documentations Administer baseline PRO forms 10/24/2014S1316 Training5

S1316 Patient Discharged from Hospital Collect MBO treatment data Collect hospitalization documentation Submit forms 10/24/2014S1316 Training6

S1316 Weeks Call patient weekly Obtain vital status Administer PRO forms Determine if patient spent any days in the hospital If patient was hospitalized, obtain hospitalization and MBO treatment data Submit forms Dietary recalls every 4 weeks 10/24/2014S1316 Training7

S Week 13 Report endpoint data –Determine which days patient was in the hospital during first 91 days after registration –Use discharge summaries and information from the weekly calls as source docs –Submit S1316 Hospitalization Days Document 10/24/2014S1316 Training8

S Weeks Call patient every 4 weeks Obtain vital status Administer PRO forms Determine if patient spent any days in the hospital Submit forms Dietary recalls every 4 weeks 10/24/2014S1316 Training9

S1316 Study Participation Complete Submit S1316 Off Protocol Notice Participation is complete when a patient: –Completes 53 weeks of follow-up –Dies Patient no longer wishes to receive phone calls but is willing to allow passive follow-up 10/24/2014S1316 Training10

S1316 Eligibility and Equipoise Clinicians must have equipoise for a patient to be eligible. That means the patient’s MBO can reasonably be treated via surgery or non- surgical medical management. Surgery Non-surgical management 10/24/2014S1316 Training11

S1316 Randomization (or not) Meets all eligibility requirements (N=180) Consents to randomization (N=50) Consents to non- randomized treatment (N=130) Surgery (50%) (Arm 1) Non-surgical management (50%) (Arm 2) Surgery (Arm 3) Non-surgical management (Arm 4) 10/24/2014S1316 Training12

S1316 Endpoint and Hospitalizations S1316 Protocol Section 1.1 Primary Objective To compare quality of life, as assessed by the number of days alive and outside of the hospital within the first 91 days (13 weeks) after registration, among patients with malignant bowel obstruction (MBO) who receive surgical intervention and similar patients treated non-surgically. 10/24/2014S1316 Training13

S1316 Obtaining Complete Endpoint Data Need hospitalization status for each day Leverage the weekly calls to cover any missed periods Protocol Section 7.5b 10/24/2014S1316 Training14

Documenting MBO Treatment 3 paper forms to document MBO treatments –S1316 MBO Treatment Form –S1316 MBO Treatment Complications Form –S1316 Somatostatin Analogue Treatment Form S1316 MBO Treatment Form –Surgery –Non-surgical –Home care 10/24/2014S1316 Training15

S1316 Active vs. Passive Follow- Up Active follow-up –Patient allows phone calls and all study activities Passive follow-up –Patient allows all study activities except phone calls –Submit S1316 Protocol Notice ASAP to stop dietary recall contacts No follow-up –Patient does not want any further follow-up of any kind –Request SWOG Consent Withdrawal Form from Data Coordinator 10/24/2014S1316 Training16

S1316 Forms and Documents Overview Form or Document Name Primary Purpose When collected How collected When submitted 10/24/2014S1316 Training17