Changes in Patient Reported Constipation Among Advanced Cancer Patients After Receiving an Educational Intervention
NCT ID: NCT02422329
Last Updated: 2018-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
59 participants
INTERVENTIONAL
2015-04-30
2018-03-07
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Questionnaires
Participants complete questionnaires at baseline and after intervention.
Video
Participants watch a 3-minute educational video describing symptoms of constipation and importance of regular bowel movements.
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.
Questionnaires
Participants complete questionnaires at baseline and after intervention.
Fact Sheet
Participants read educational material describing symptoms of constipation and importance of regular bowel movements.
Interventions
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Questionnaires
Participants complete questionnaires at baseline and after intervention.
Video
Participants watch a 3-minute educational video describing symptoms of constipation and importance of regular bowel movements.
Fact Sheet
Participants read educational material describing symptoms of constipation and importance of regular bowel movements.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age \>/= 18 years old
3. Patients must be able to understand, read, write, and speak English
4. Patients must have no clinical evidence of cognitive impairment as determined by the palliative care physician (Memorial Delirium Assessment Score \>/= 7)
5. Patients must sign an informed consent
Exclusion Criteria
2. Patients with complete or partial bowel obstruction as determined by the palliative care physician
3. Patients with a bowel ostomy
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Eduardo Bruera, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2015-00734
Identifier Type: REGISTRY
Identifier Source: secondary_id
2015-0111
Identifier Type: -
Identifier Source: org_study_id
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