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S1316 – The Malignant Bowel Obstruction Study A Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction SWOG Study Chairs:SWOG Study.

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Presentation on theme: "S1316 – The Malignant Bowel Obstruction Study A Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction SWOG Study Chairs:SWOG Study."— Presentation transcript:

1 S1316 – The Malignant Bowel Obstruction Study A Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction SWOG Study Chairs:SWOG Study Chairs: Robert S. Krouse, M.D., SAVAHCS/University of Arizona, Surgical Oncology Brian Badgwell, M.D., MD Anderson Cancer Center Alliance Investigator:Alliance Investigator: Amy Abernethy, M.D., Duke University Medical Center Nurse Chair:Nurse Chair: Virginia Sun, R.N., Ph.D., City of Hope S MBO Professional Slide Set, Version 01

2 S1316 JACS 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? S MBO Professional Slide Set, Version 01

3 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? S MBO Professional Slide Set, Version 01

4 S1316 – MBO Study Primary 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 with NG tube Days eating (Diet recalls) Days eating (Diet recalls) HRQOL (MDASI-GI, EQ-5D-5L) HRQOL (MDASI-GI, EQ-5D-5L) Morbidity/Mortality Morbidity/Mortality Survival Survival S MBO Professional Slide Set, Version 01

5 S1316 Study Timeline Study accrues 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

6 S MBO Study Schema S 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.

7 S MBO Professional Slide Set, Version 01 S1316 Patient Timeline Hospitalization with MBO Week 53 Follow-up Complete Day 0 Registration 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

8 S MBO Study Accrual 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) S MBO Professional Slide Set, Version 01

9 S1316 – MBO Study Eligibility 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 one week prior to admission) Able to complete questionnaires in English S MBO Professional Slide Set, Version 01

10 S1316 – MBO Study Ineligibility 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 S MBO Professional Slide Set, Version 01

11 S1316 – MBO Study Timeline for Initial Patient Care S 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 daysUp to 2 working days | | | Surgical Consult or admission to Surgical Service Register to S1316Begin Treatment

12 S1316 – MBO Study Initial 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 S MBO Professional Slide Set, Version 01

13 S1316 – MBO Study Follow-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 S MBO Professional Slide Set, Version 01

14 S1316 – MBO Study Dietary 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 S MBO Professional Slide Set, Version 01

15 S1316 – MBO Study Criteria 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. S MBO Professional Slide Set, Version 01

16 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) S MBO Professional Slide Set, Version 01

17 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) S MBO Professional Slide Set, Version 01

18 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 S MBO Professional Slide Set, Version 01

19 S1316 – MBO Study Recruitment Materials & Resources Professional Slide Set Patient Brochure Resources: S1316 webpage - S1316 Working Group: Conference calls S MBO Professional Slide Set, Version 01

20 S1316 – MBO Study Participating Study Sites S MBO Professional Slide Set, Version 01 University of Arizona Setsuko K. Chambers, MD (Gyn Onc) Valentine Nfonsam, MD (Colorectal Surg) Duke University Amy P. Abernethy, MD (Med Onc/HPM) Paul J. Mosca, MD, PhD (Surg Onc) Angeles Secord, MD (Gyn Onc) MD Anderson Cancer Center Brian 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 Center Betty Ferrell, PhD, MA (Nursing Research) Ernest Han, MD (Gyn Onc) Gagandeep Singh, MD (Surg Onc) Yuman Fong, MD (Surg Onc) University of Michigan Phillip E. Rodgers, MD (HPM) Samantha Hendren, MD (Colorectal Surg ) Kevin Reynolds, MD (Gyn Onc) Memorial Sloan-Kettering Cancer Center Dennis Chi, MD (Gyn Onc) Nadeem Abu-Rustum, MD (Gyn Onc) Ginger Gardner, MD (Gyn Onc) Larissa K. F. Temple, MD (Colorectal Surg)

21 Thank You S MBO Professional Slide Set, Version 01


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