- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02422329
Changes in Patient Reported Constipation Among Advanced Cancer Patients After Receiving an Educational Intervention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
If participant agrees to take part in the study, information about them (such as their age, gender, ethnicity, religion, diagnosis, and drugs they are currently taking) will be collected from their medical record.
Participant will also complete 1 questionnaire about constipation. It should take about 1-3 minutes to complete the questionnaire.
After completing the questionnaire, participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. Participant will have an equal chance of being in either group.
- If participant is assigned to Group 1, they will watch a short educational video.
- If participant is assigned to Group 2, they will read a fact sheet.
Both the video and the fact sheet describe symptoms of constipation and the importance of regular bowel movements. They should take about 3 minutes each to complete.
After participant has viewed the educational material, they will complete 3 questionnaires about constipation and how helpful they think the video or fact sheet was in educating them about constipation. It should take about 10 minutes total to complete these questionnaires. Participant will watch the video/read the fact sheet and complete the questionnaires in their room at the Supportive Care Clinic.
Length of Study:
Patient's participation on this study will be over after they have completed the last 3 questionnaires.
This is an investigational study.
Up to 200 participants will be enrolled in the study. All will take part at MD Anderson.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
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Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with diagnosis of advanced cancer, including recurrent, locally advanced, or metastatic cancer
- Age >/= 18 years old
- Patients must be able to understand, read, write, and speak English
- Patients must have no clinical evidence of cognitive impairment as determined by the palliative care physician (Memorial Delirium Assessment Score >/= 7)
- Patients must sign an informed consent
Exclusion Criteria:
- Patients with a diagnosis of inflammatory bowel disease, i.e. Crohn's disease or ulcerative colitis
- Patients with complete or partial bowel obstruction as determined by the palliative care physician
- Patients with a bowel ostomy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Educational Video
Participants complete self-administered numerical rating scale (NRS) constipation questionnaire at baseline.
Participants watch a 3-minute educational video describing symptoms of constipation and importance of regular bowel movements.
Participants then complete three self-administered questionnaires, post-educational material, Modified Rome III questionnaire, and Overall satisfaction of the educational material.
|
Participants complete questionnaires at baseline and after intervention.
Other Names:
Participants watch a 3-minute educational video describing symptoms of constipation and importance of regular bowel movements.
|
Experimental: Fact Sheet
Participants complete self-administered numerical rating scale (NRS) constipation questionnaire at baseline.
Participants read educational material describing symptoms of constipation and importance of regular bowel movements.
Participants then complete three self-administered questionnaires, post-educational material, Modified Rome III questionnaire, and Overall satisfaction of the educational material.
|
Participants complete questionnaires at baseline and after intervention.
Other Names:
Participants read educational material describing symptoms of constipation and importance of regular bowel movements.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient-Reported Perception of Constipation
Time Frame: 1 day
|
Primary objective is to examine effect of educational intervention on the patient-reported perception of constipation (PRC, by a 0-10 numeric rating score) among advanced cancer patients.
|
1 day
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-0111
- NCI-2015-00734 (Registry Identifier: NCI CTRP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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