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

Advanced Cancers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02422329
• Other study ID #: 2015-0111
• Secondary ID: NCI-2015-00734
• Status: Completed
• Phase: N/A
• First received: April 16, 2015
• Last updated: March 20, 2018
• Start date: April 30, 2015
• Est. completion date: March 7, 2018

Study information

• Verified date: March 2018
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 7, 2018
• Est. primary completion date: March 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancers
• Constipation
• Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day

External Links

•   University of Texas MD Anderson Cancer Center Website