Managing Medication-induced Constipation in Cancer: A Clinical Trial
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
Phase I - Record of Each Participant's Constipation Incidents and Their Corresponding Opioid Dose
Relationship Between Constipation Intensity and Opioid Dose. To identify the incidence, severity, distress and trajectory of constipation in cancer patients receiving opioids over an 8 week period and to evaluate the relationships between constipation intensity and opioid dose.
Susan McMillan, Ph.D., RN
University of South Florida
United States: Institutional Review Board
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|