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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02422329
Enrollment
59
Registered
2015-04-21
Start date
2015-04-30
Completion date
2018-03-07
Last updated
2018-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cancers

Keywords

Advanced Cancers, Constipation, Recurrent cancer, Locally advanced cancer, Metastatic cancer, Video, Fact sheet, Questionnaires, Surveys

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.

Interventions

BEHAVIORALVideo

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

BEHAVIORALFact Sheet

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

BEHAVIORALQuestionnaires

Participants complete questionnaires at baseline and after intervention.

Sponsors

M.D. Anderson Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patient-Reported Perception of Constipation1 dayPrimary 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026