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S1316 – The Malignant Bowel Obstruction StudyA Prospective Comparative Effectiveness Trial for
Malignant Bowel Obstruction
• SWOG Study Chairs:
Robert S. Krouse, M.D., SAVAHCS/University of Arizona, Surgical Oncology
Brian Badgwell, M.D., MD Anderson Cancer Center
• Alliance Investigator:
Amy Abernethy, M.D., Duke University Medical Center
• Nurse Chair:
Virginia Sun, R.N., Ph.D., City of Hope
S1316 - MBO Professional Slide Set, Version 01
S1316JACS Paper on MBO
•Aggressive non-surgical palliative care options can help avoid an operation
•There are many clinical scenarios when an operation is unlikely to benefit MBO patients
•Can we test which treatment strategy (surgery vs. “aggressive” palliative management) is optimal in MBO?
S1316 - MBO Professional Slide Set, Version 01
S1316- MBO Study Aims
To assess the quality of life outcome of the number of days alive and outside of the hospital within the first 91 days (13 weeks) after registration, for patients with malignant bowel obstruction who receive surgical intervention as compared to non-surgical intervention.
Research Questions:
• Are there differences in HRQOL outcomes for patients with MBO who receive surgical intervention as compared to non-surgical intervention?
• Are there clinical factors that predict better HRQOL outcomes for patients with MBO who receive surgical or non-surgical intervention?
S1316 - MBO Professional Slide Set, Version 01
S1316 – MBO StudyPrimary Endpoint
“Good days” = days out of the hospital and alive in the first 91 days (13 weeks) after registration Secondary Endpoints• Days with NG tube• Days eating (Diet recalls)• HRQOL (MDASI-GI, EQ-5D-5L) • Morbidity/Mortality• Survival
S1316 - MBO Professional Slide Set, Version 01
S1316 - MBO Professional Slide Set, Version 01
S1316 Study Timeline
2014 2015 2016
Study accrues
2017 2018
Study closes
to accrual
Prepare for study activation
Training
Obtain IRB approvals
2019
Study data complete and
submitted
• Complete data clean-up• Analyze data for primary
endpoint• Prepare abstract• Write and publish primary
paper
Work on secondary analyses
2020
S1316 - MBO Study Schema
S1316 - MBO Professional Slide Set, Version 01
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)
All patients will be followed for 53 weeks.
S1316 - MBO Professional Slide Set, Version 01
S1316 Patient Timeline
Hospitalization with MBO
Week 53
Follow-up Complete
Day 0Registration
Week 13
Data for primary endpoint reported
• Site calls patient every 4 weeks for assessments
• Patient has dietary recall every 4 weeks
• Report all hospitalizations• Site calls patient weekly for
assessments• Patient has dietary recall every
4 weeks
S1316 - MBO StudyAccrual Goal
• Study will accrue 180 eligible patients
• Study expects to accrue over 3 years
• Two study components
– Randomization component (n=50)– Non-randomized component (n=130)
S1316 - MBO Professional Slide Set, Version 01
S1316 – MBO StudyEligibility Criteria
• MBO due to intra-abdominal cancer
• Admission to hospital
• Surgical candidate (would tolerate an operation and indication for surgery)
• Performance status (Zubrod Performance Status of 0 - 2 one week prior to admission)
• Able to complete questionnaires in English
S1316 - MBO Professional Slide Set, Version 01
S1316 – MBO StudyIneligibility Criteria (cont’d)
• MBO not due to intra-abdominal cancer
• Patient actively dying
• Patient requires an emergency surgical procedure, e.g., acute abdomen
• Patient refuses to allow study staff to contact him/her for study follow-up
S1316 - MBO Professional Slide Set, Version 01
S1316 – MBO StudyTimeline for Initial Patient Care
S1316 - MBO Professional Slide Set, Version 01
Time from initial surgical consult to start of treatment should not be more than a week.
Treatment may begin on the same day as the surgical consult as long as the order of events is preserved (surgical consult first, then registration, then treatment).
Treatment must begin after registration. Patients for whom treatment is initiated prior to registration are ineligible.
Up to 3 working days Up to 2 working days
|----------------------------|---------------------------|Surgical Consult or admission to Surgical Service
Register to S1316 Begin Treatment
S1316 – MBO StudyInitial Data Submission
• Baseline data– Onstudy, MDASI-GI, EQ-5D-5L
• MBO treatment and complications data for initial hospitalization
• Pathology report to confirm primary cancer
• Radiology reports to confirm MBO
S1316 - MBO Professional Slide Set, Version 01
S1316 – MBO StudyFollow-Up
• Weekly phone assessments and data collection by study site staff for first 13 weeks and every 4 weeks thereafter up to one year
• Dietary recall phone calls every 4 weeks up to one year
• MBO treatment and complications data for all hospitalizations in first 13 weeks
S1316 - MBO Professional Slide Set, Version 01
S1316 – MBO StudyDietary Recall
• Self-reported diet measurement methods
• Relies on patient or caregiver to report foods consumed in prior 24-hour period
• Collected by Arizona Diet, Behavior, Quality of Life Assessment Lab through phone contact
S1316 - MBO Professional Slide Set, Version 01
S1316 – MBO StudyCriteria for Removal from Protocol Follow-up
• Completion of 53 weeks on study• Medical condition that the treating
investigator believes precludes continued participation
• Patient refusal for any reason, including discontinuation of weekly phone calls
All reasons for discontinuation of follow-up will be documented but hospitalization data and vital status will still be reported.
S1316 - MBO Professional Slide Set, Version 01
S1316 – MBO Study Analysis Plan
Study includes two components: randomized (n=50) and non-randomized (n=130)
Inference will be based on assigned treatment• Randomized component will use
randomized treatment (intent to treat)• Non-randomized component will use
initially chosen treatment (pseudo-intent to treat)
S1316 - MBO Professional Slide Set, Version 01
Analysis Plan (cont’d)
Initial analysis will use pooled data from both components
• Use multivariate linear regression model• Include parameters for potential
confounders• Include parameter for study component
(randomized vs. non-randomized)
S1316 - MBO Professional Slide Set, Version 01
Analysis Plan (cont’d)
Assess bias in treatment group (surgical vs. non-surgical) between components (randomized vs. non-randomized)• No evidence of residual bias after controlling
for potential confounders?– Use pooled data for primary analysis
• Evidence of residual bias?– Report on both components– Use randomized data only for primary
analysis
S1316 - MBO Professional Slide Set, Version 01
S1316 – MBO StudyRecruitment Materials & Resources
• Professional Slide Set• Patient Brochure
Resources:• S1316 webpage -
http://swog.org/Visitors/S1316/Index.asp• S1316 Working Group: [email protected] • Conference calls
S1316 - MBO Professional Slide Set, Version 01
S1316 – MBO StudyParticipating Study Sites
S1316 - MBO Professional Slide Set, Version 01
University of ArizonaSetsuko K. Chambers, MD (Gyn Onc)Valentine Nfonsam, MD (Colorectal Surg)
Duke UniversityAmy P. Abernethy, MD (Med Onc/HPM)Paul J. Mosca, MD, PhD (Surg Onc)Angeles Secord, MD (Gyn Onc)
MD Anderson Cancer CenterBrian D. Badgwell, MD, MS (Surg Onc)Richard Royal, MD (Surg Onc)Robert Coleman, MD (Gyn Onc)Larissa Meyer, MD (Gyn Onc)George Chang, MD (Surg Onc)Karen Lu, MD (Gyn Onc)
City of Hope Cancer CenterBetty Ferrell, PhD, MA (Nursing Research)Ernest Han, MD (Gyn Onc)Gagandeep Singh, MD (Surg Onc)Yuman Fong, MD (Surg Onc)
University of MichiganPhillip E. Rodgers, MD (HPM)Samantha Hendren, MD (Colorectal Surg )Kevin Reynolds, MD (Gyn Onc)
Memorial Sloan-Kettering Cancer CenterDennis Chi, MD (Gyn Onc)Nadeem Abu-Rustum, MD (Gyn Onc)Ginger Gardner, MD (Gyn Onc)Larissa K. F. Temple, MD (Colorectal Surg)
Thank You
S1316 - MBO Professional Slide Set, Version 01