Managing Medication-induced Constipation in Cancer: A Clinical Trial



Status:Completed
Conditions:Constipation
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:10/19/2013
Start Date:November 2008
End Date:January 2014
Contact:Susan McMillan, Ph.D., RN
Email:smcmilla@health.usf.edu
Phone:813-745-9188

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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.


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.

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.
We found this trial at
1
site
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Tampa, FL
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