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Changes in Patient Reported Constipation Among Advanced Cancer Patients After Receiving an Educational Intervention

Primary Purpose

Advanced Cancers

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Questionnaires
Video
Fact Sheet
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Advanced Cancers focused on measuring Advanced Cancers, Constipation, Recurrent cancer, Locally advanced cancer, Metastatic cancer, Video, Fact sheet, Questionnaires, Surveys

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with diagnosis of advanced cancer, including recurrent, locally advanced, or metastatic cancer
  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:

  1. Patients with a diagnosis of inflammatory bowel disease, i.e. Crohn's disease or ulcerative colitis
  2. Patients with complete or partial bowel obstruction as determined by the palliative care physician
  3. Patients with a bowel ostomy

Sites / Locations

  • University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Educational Video

Fact Sheet

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Patient-Reported Perception of Constipation
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.

Secondary Outcome Measures

Full Information

First Posted
April 16, 2015
Last Updated
March 20, 2018
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02422329
Brief Title
Changes in Patient Reported Constipation Among Advanced Cancer Patients After Receiving an Educational Intervention
Official Title
Changes in Patient Reported Constipation Among Advanced Cancer Patients After Receiving an Educational Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 30, 2015 (Actual)
Primary Completion Date
March 7, 2018 (Actual)
Study Completion Date
March 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this research study is to learn how patients' think about constipation before and after receiving education about the subject.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cancers
Keywords
Advanced Cancers, Constipation, Recurrent cancer, Locally advanced cancer, Metastatic cancer, Video, Fact sheet, Questionnaires, Surveys

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Educational Video
Arm Type
Experimental
Arm Description
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.
Arm Title
Fact Sheet
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Questionnaires
Other Intervention Name(s)
Surveys
Intervention Description
Participants complete questionnaires at baseline and after intervention.
Intervention Type
Behavioral
Intervention Name(s)
Video
Intervention Description
Participants watch a 3-minute educational video describing symptoms of constipation and importance of regular bowel movements.
Intervention Type
Behavioral
Intervention Name(s)
Fact Sheet
Intervention Description
Participants read educational material describing symptoms of constipation and importance of regular bowel movements.
Primary Outcome Measure Information:
Title
Patient-Reported Perception of Constipation
Description
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.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Bruera, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

Learn more about this trial

Changes in Patient Reported Constipation Among Advanced Cancer Patients After Receiving an Educational Intervention

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