View Clinical Trial (Medical Research Study)
Managing Medication-induced Constipation in Cancer: A Clinical Trial
| City: |
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Tampa |
| State: |
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Florida |
| Zip Code: |
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33612 |
| Conditions: |
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Constipation |
| Purpose: |
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The purpose of this research is to evaluate the effectiveness of the Constipation Treatment
Protocol and to test whether management according to dose of constipation-inducing
medications or according to on-going assessment is most effective.
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| Study Summary: |
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Patients will undergo a baseline assessment during their regular outpatient visit. With
their permission, the investigators will audio record this visit for quality control. After
the study, the recordings will be erased. Patients will be asked to complete 4
questionnaires. The investigators will collect contact information so that the follow-up
assessments can be done by phone.
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| Criteria: |
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Inclusion Criteria:
- The study sample will consist of patients who are receiving outpatient care at the
Moffitt Cancer Center.
- Patients will be identified as those who have a diagnosis of cancer and are being
treated with either opioids or vinca alkaloids,
- are adults (or children 18-21 years old),
- either male or female,
- able to read and understand English,
- and able to pass screening with the Short Portable Mental Status Questionnaire and
Karnofsky Performance Status Scale.
Exclusion Criteria:
- Patients will be excluded: if they have non-melanoma skin cancer or colorectal or
gynecological cancer as their primary diagnosis;
- if they are excessively debilitated or deemed unlikely to survive for the eight weeks
of the data collection period;
- if they are unable to read and understand English;
- if they have an ostomy that changes bowel function;
- if they have a current peritoneal catheter;
- if they have had abdominal surgery within the past six weeks;
- or have a disease process suggestive of mechanical obstruction (tumor or adhesion);
- if they have a history of chronic bowel disease (including irritable bowel syndrome,
chronic constipation prior to cancer onset, Crohn's disease, ulcerative colitis or
diarrhea as a result of radiation to the pelvis), or report chronic laxative use
prior to cancer onset.
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| NCT ID: |
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NCT01416909 |
| Primary Contact: |
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Principal Investigator
Susan McMillan, Ph.D., RN
University of South Florida
Susan McMillan, Ph.D., RN
Phone: 813-745-9188
Email: smcmilla@health.usf.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Tampa, Florida 33612
United States
Amy Franklin
Phone: 813-745-1841
Email: amy.franklin@moffitt.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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