SWOG Study S1316 Page

This page is for reference and assistance to study sites participating in SWOG's clinical trial S1316, "Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction."

Why is this study being done?

Malignant bowel obstruction (MBO) is a common problem for patients with advanced abdominal or pelvic cancers. This study is being done to determine whether surgery will improve an MBO patient's quality of life, or whether the surgery provides little benefit.

The study has two arms, surgery or non-surgical management, and patients are randomized to a treatment arm. Both treatments are considered standard of care for patients with MBO.

More information about the study?
  • Members version of the protocol abstract page (from which the full protocol is available): S1316 Protocol Abstract Page. Staff from non-SWOG sites can find the full protocol and related materials by logging in to the CTSU site.
  • For general questions about the study, select "Protocols" as the subject area on the Contact Us page and we will get in touch with you.
  • Participants can find a more comprehensive list of locations, including non-SWOG locations, where this trial is open in the "Contacts and Locations" section of ClinicalTrials.gov S1316 page.

Patient Contact Forms

  • S1316 Dietary Recall Contact Form: This form will be submitted to the Arizona Diet, Behavior and Quality of Life Assessment Lab for the dietary recall portion of the study.
  • S1316 Participant Contact Form: This form will be used to obtain contact information for your site to use for the weekly phone calls and assessments. This form is for your information only and should not be submitted to the SWOG Data Operations Office.

Staff Training Information and Material

Eligibility Issue: Potential Participants Concerned with the Number of Phone Contacts
If you have a patient who would like to participate on the study but is concerned with the burden of the follow-up calls, discuss the following options and the importance of the hospitalization data for the study:

  • Patients may designate a representative or alternate contact to respond to the calls on their behalf.
  • The first priority for data collection is for the hospitalization information on the weekly calls about quality of life from the site staff. If the patient and/or their representative want only to give that information, the call can be limited to that.
  • Patients may refuse to complete one or more questionnaires during the call.
  • Patients and/or their representative may refuse to complete a dietary recall.
  • Patients who wish to stop all future calls may request this and allow their hospitalization data be gathered from their hospital records (this is passive follow-up - and requires submission of the S1316 Off Protocol form).

Monthly Calls for Study Site Staff with the S1316 Research Team

There are monthly teleconference calls (30-60 minutes) available for site staff from open and planning-to-open study sites to discuss study issues with the research team. The calls are every 2nd Wednesday of the month, 1:00 P.M. ET, 12:00 P.M. CT, and 10:00 A.M. PT.

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Staff Newsletters

Materials for Patients

Please use the patient handouts below as needed. Your institution must obtain local IRB approval prior to distributing these handouts to patients,

Carefully review the document and fill in or delete any italicized text.

Staff Training Information

Internal Promotional Materials

  • S1316 Internal Recruitment Flyer (fillable PDF):  This one page flyer is an internal recruitment tool for promoting the study among physicians and staff at local institutions. It can be posted where your surgeons may see potential MBO patients. See the printing instructions for how to add your contact information to the tear off section.
  • S1316 Protocol Card:  This information can be reduced in size to fit into a lab pocket sized document or printed standard size to fit in an open protocols binder or notebook for staff to have a quick reference to study schema and eligibility information. Please check the protocol for the complete eligibility information.

General Recruitment Materials

General Information

  • S1316 Patient Accrual Tracking Log:  This is an optional use spreadsheet for participating sites to track all potential MBO patients. Instructions for use and submission are on the spreadsheet.