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

M.D. Anderson Cancer Center

Status: Completed

Conditions: Advanced Cancers

Treatments: Behavioral: Fact Sheet; Behavioral: Questionnaires; Behavioral: Video

Study type: Interventional

Funder types: Other

Identifiers

NCT02422329

2015-0111

NCI-2015-00734 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

59 participants in 2 patient groups

Educational Video

Experimental group

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.

Treatment:

Behavioral: Questionnaires

Behavioral: Video

Fact Sheet

Experimental group

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.

Treatment:

Behavioral: Questionnaires

Behavioral: Fact Sheet