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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
601
Participants will be taken off any laxative preparation they may already be on. Patients will be put on laxative treatment based on the Constipation Treatment Protocol.
Participants will receive their usual care at Moffitt while participating in weekly assessments. After participation in the study is complete, participants will be offered the same protocol that is given to patients in the treatment groups.
Constipation Assessment Scale (CAS), Laxative Interview (based on Laxative Diary completed by patients), Memorial Symptom Assessment Scale (MSAS), Functional Assessment of Cancer Therapy-General (FACT-G).
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Phase I - Record Constipation Incidence and Symptoms
To identify the incidence, severity, distress and trajectory of constipation in cancer patients receiving opioids over an eight week period and to evaluate the relationships between constipation intensity and opioid dose. To identify the incidence, severity, distress and trajectory of constipation in groups of cancer patients who may be at risk due to vinca alkaloids (vincristine. vinblastine. vinorelbine and vindesine) over an eight week period and to evaluate the relationship between constipation intensity and vinca alkaloid dose.
Time frame: 18 months
Phase II - Number of Participants With Desired Effect - Patients with Medication-induced Constipation
To test the efficacy of a Constipation Treatment Protocol in patients with medication-induced constipation.
Time frame: 2 years, 3 months
Phase II - Best Determination of Laxative Dose - Patients with Medication-induced Constipation
To test whether laxative dose is best determined based on on-going assessment or on opioid dose. To test whether laxative dose is best determined based on on-going assessment or on vinca alkaloid dose.
Time frame: 2 years, 3 months
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