Clinical trial NCT02422329: 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
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancers
Keywords: Advanced Cancers
Constipation
Recurrent cancer
Locally advanced cancer
Metastatic cancer
Video
Fact sheet
Questionnaires
Surveys
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2015-04-21
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient-Reported Perception of Constipation
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Eduardo Bruera, MD
role: PRINCIPAL_INVESTIGATOR
References: