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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- S1316-MBO Study (July 2019)
- S1316-MBO Study (March 2019)
- S1316-MBO Study (December 2018)
- S1316-MBO Study (September 2018)
- S1316-MBO Study (June 2018)
- S1316-MBO Study (March 2018)
- S1316-MBO Study (December 2017)
- S1316-MBO Study (September 2017)
- S1316-MBO Study (June 2017)
- S1316-MBO Study (February 2017)
- S1316-MBO Study (November 2016)
- S1316-MBO Study (August 2016)
- S1316-MBO Study (July 2016)
- S1316-MBO Study (June 2016)
- S1316-MBO Study (May 2016)
- S1316-MBO Study (April 2016)
- S1316-MBO Study (March 2016)
- S1316-MBO Study (February 2016)
- S1316-MBO Study (January 2016)
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.
- S1316 Patient Brochure (fillable PDF): You may use this patient brochure as an additional resource when you present study S1316 to prospective patients. Add your contact information in the area provided. Print this document on 8.5 x 11-size paper, double sided and fold it. If you have a color printer, the brochure will print in light blue, black and white. (Brochure Instructions)
- S1316 Patient Brochure, Spanish (fillable PDF)
- Brochure Certified Translation Certificate
- Sympathy Card, English (fillable PDF)
- Sympathy Card, Spanish (fillable PDF)
- Sympathy Card Certified Translation Certificate
Staff Training Information
- S1316 Training Slide Sets:
- S1316 IRB Information Sheet (PDF): Include this sheet with your IRB Packet when submitting S1316 to your IRB for the first time.
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
- 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.
- S1316 MedDRA Codes for MBO Cancers
Study specific questions may be sent to S1316@swog.org
For questions about publicizing the trial in your local media, please contact email@example.com
For assistance with additional recruitment or retention materials, contact Jennifer Maeser at firstname.lastname@example.org