NCT01416909

Managing Medication-induced Constipation in Cancer: A Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 601 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Constipation

Interventions

Type	Name	Description
OTHER	Laxative Treatment	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.
OTHER	Standard of Care	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.
OTHER	Assessment Questionnaires	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).

Timeline

• Start date: 2008-11-01
• Primary completion: 2013-08-01
• Completion: 2014-01-01
• First posted: 2011-08-15
• Last updated: 2017-02-23

Locations

1 site across 1 country: United States