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OpenTrials
Completed

NCT Number: NCT02422329

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaires

Behavioral

Participants complete questionnaires at baseline and after intervention.

Other names: Surveys

Video

Behavioral

Participants watch a 3-minute educational video describing symptoms of constipation and importance of regular bowel movements.

Fact sheet

Behavioral

Participants read educational material describing symptoms of constipation and importance of regular bowel movements.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 21, 2015
Registry last updated
Mar 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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