Clinical trial NCT01416909: Managing Medication-induced Constipation in Cancer: A Clinical Trial
Official title: Managing Medication-induced Constipation in Cancer: A Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Keywords: Medication-induced
Constipation in Cancer
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: University of South Florida
First posted: 2011-08-15
Enrollment: 601
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Phase I - Record Constipation Incidence and Symptoms
timeFrame: 18 months
Secondary outcomes:
measure: Phase II - Number of Participants With Desired Effect - Patients with Medication-induced Constipation
timeFrame: 2 years, 3 months
measure: Phase II - Best Determination of Laxative Dose - Patients with Medication-induced Constipation
timeFrame: 2 years, 3 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: University of South Florida
name: Susan McMillan, Ph.D., RN
role: PRINCIPAL_INVESTIGATOR
References: