S1316, Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction
Phase: NA
Conditions: Constipation, Impaction, and Bowel Obstruction, Unspecified Adult Solid Tumor, Protocol Specific
Sponsor: SWOG Cancer Research Network

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S1316 
 
Page 18 
 
Version Date 6/18/19 
 
 
 
9.0 
STUDY CALENDAR 
 
REQUIRED STUDIES 
Hospital 
Admission/ 
Baseline 
W 
W 
W 
W 
W 
W 
W 
W 
W 
W 
W 
W 
W 
F/U every 
4 Weeks 
through 
Wk 53 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
PHYSICAL 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
History and Physical Exam  π 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Weight and Performance Status 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Patient Assessment α 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
LABORATORY 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Serum Albumin 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CBC  † 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Electrolyte Panel (sodium, potassium, bicarbonate, 
chloride, BUN, creatinine)  † 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SCANS 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CT or MRI for disease assessment 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X-ray/Abdominal Plain Film Ω 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PATIENT QUESTIONNAIRES & FOLLOW-UP 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
S1316 Cover Sheet for Patient-Completed 
Questionnaires 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
S1316 MDASI-GI 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
S1316 EQ-D5 
X 
 
X 
 
X 
 
 
 
X 
 
 
 
X 
 
 
S1316 MBO Assessment 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
S1316 MBO Follow-Up 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
S1316 Hospitalization Days Record β 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
S1316 Dietary Recall Contact Information Form 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Dietary Recall δ 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
X 
TREATMENT 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Surgery (Arms 1 and 3) 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Non-surgical management (Arms 2 and 4) 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Footnotes: 
α  Weekly follow-up during Weeks 2-13 will take place by phone or in person if patient is in the hospital (see Section 7.5b). 
β  Assessment done weekly; data reported at Week 13. 
†   Recommended laboratory values to be collected on the S1316 On Study Form if testing is performed. 
δ  To be administered monthly by phone by the Arizona Diet, Behavior and Quality of Life Assessment Lab (see Section 7.4). 
π Including pathology report of primary intra-abdominal cancer (see Section 14.4b). 
Ω If CT is obtained for MBO confirmation, then it may be used rather than x-ray. 

 
S1316 
 
Page 19 
 
Version Date 6/18/19 
 
 
 
10.0 
CRITERIA FOR EVALUATION AND ENDPOINT ANALYSIS 
 
10.1 
Primary Endpoint 
 
The primary endpoint for this study is number of days alive and outside the hospital within 
the first 91 days after enrollment, as recorded on the S1316 Hospitalization Days Record. 
The time window for each weekly assessment is +/- 2 days to allow for practical 
CRA/patient considerations including (but not limited to) scheduling of telephone calls 
and possible missed telephone calls. 
 
10.2 
MDASI-GI  
 
The MDASI-GI is a well-validated instrument with each item, based on a 0-10 scale, 
designed as an independent domain related to specific HRQOL issues for patients with 
gastrointestinal cancers. While the MDASI is not intended to produce a total score, one 
can calculate a total symptom index. It is a valid, reliable, and concise tool to measure 
the severity of symptoms for patients with GI cancer. This will give the ability to compare 
outcomes for many of the most important patient reported outcomes for MBO patients, 
such as nausea, vomiting, feeling bloated, and pain. A movement of two points on each 
0-10 point scale is considered as clinically meaningful and cutoff scores for indication of 
clinical deficits have been defined by the tool authors. 
 
10.3 
EQ-5D-5L 
 
The EQ-5D-5L is designed for the collection of health state values using a visual 
analogue scale  with the end points labeled best imaginable health state at the top and 
worst imaginable health state at the bottom having numeric values of 100 and 0 
respectively. The EQ-5D-5L has been widely used in clinical trials in quality-adjusted 
survival efforts. (26,27,28,29) We will combine the MDASI-GI index score with EQ-5D-5L 
total score to produce a quality-adjusted life years (QALY)- adjusted outcome measure. 
(30) 
 
10.4 
Performance Status 
 
Patients will be graded according to the Zubrod Performance Status Scale. 
 
 
POINT  
DESCRIPTION 
 
0 
Fully active, able to carry on all pre-disease performance without 
restriction. 
 
1 
Restricted in physically strenuous activity but ambulatory and able to 
carry out work of a light or sedentary nature, e.g., light housework, office 
work. 
 
2 
Ambulatory and capable of self-care but unable to carry out any work 
activities; up and about more than 50% of waking hours. 
 
3 
Capable of limited self-care, confined to bed or chair more than 50% of 
waking hours. 
 
4 
Completely disabled; cannot carry on any self-care; totally confined to bed 
or chair. 
 

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S1316 
 
 
Page 11 
 
 
Version Date 6/18/19 
 
 
 
 
S1316 Dietary Recall Contact Form 
 
Instructions:  This form will be used by the Arizona Diet, Behavior, and Quality of Life Assessment Lab 
to contact the patient to conduct the S1316 24-hour dietary recalls.   
Email this form to the Arizona Diet, Behavior, and Quality of Life Assessment Lab within 24 hours after 
registration to S1316. Always follow your institutional HIPAA policies for emailing PHI. 
You must use the following address to submit this form: UACC-MBO@uacc.arizona.edu  
 
Patient First Name and Last Name Initial: __________________________________________ 
Site Name __________________________ 
SWOG Site # or NCI code: ______________ 
Name of Nurse/CRA who will be contacting this patient for weekly site calls: Patient’s preferred language: 
_____________________________________________      English 
     Spanish 
SWOG  ID:  __  __  __  __  __  __  __  __  __  __    
 
Registration Date:_________________ 
Phone # (best):  (  _  _  _  ) _  _  _  ̶  _  _  _  _  Cell / Land   Time Zone (Please circle):  ET   CT   MT   PT 
Phone Number (alt): (  _  _  _  )  _  _  _   ̶   _  _  _  _  Cell / Land  Time Zone (Please circle): ET CT MT PT 
□ Okay to text the patient for scheduling purposes only if this box is marked  
Full name of an authorized alternate contact who could respond to dietary questions (always provide): 
____________________________________________________________________________________ 
Alternate’s contact phone number (best):  (  _  _  _  )  _  _  _   ̶   _  _  _  _     Cell / Land 
Alternate’s Email address:______________________________________________________________ 
NOTES re: Alternate Contact: ____________________________________________________ 
 
□ DO NOT CALL THE PATIENT if this box is marked; use the authorized alternate contact for the 
information. 
Preferred time to call (place “yes” in available times): 
Time 
Mon 
Tue 
Wed 
Thu 
Fri 
Sat 
Sun 
Morning - Anytime  
 
 
 
 
 
 
 
7 -  9 AM 
 
 
 
 
 
 
 
9 - 11 AM  
 
 
 
 
 
 
 
11 - noon 
 
 
 
 
 
 
 
Afternoon - Anytime  
 
 
 
 
 
 
 
Noon - 2 PM 
 
 
 
 
 
 
 
2 - 4 pm 
 
 
 
 
 
 
 
4 – 6 pm 
 
 
 
 
 
 
 
Evening 
 
 
 
 
 
 
 
6 – 8 pm 
 
 
 
 
 
 
 
Other