NCT02422329

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
9 days until next milestone

Study Start

First participant enrolled

April 30, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2018

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

2.9 years

First QC Date

April 16, 2015

Last Update Submit

March 20, 2018

Conditions

Advanced Cancers

Keywords

Advanced CancersConstipationRecurrent cancerLocally advanced cancerMetastatic cancerVideoFact sheetQuestionnairesSurveys

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Educational Video

EXPERIMENTAL

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.

Behavioral: QuestionnairesBehavioral: Video

Fact Sheet

EXPERIMENTAL

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.

Behavioral: QuestionnairesBehavioral: Fact Sheet

Interventions

QuestionnairesBEHAVIORAL

Participants complete questionnaires at baseline and after intervention.

Also known as: Surveys
Educational VideoFact Sheet
VideoBEHAVIORAL

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

Educational Video
Fact SheetBEHAVIORAL

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

Fact Sheet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

ConstipationRecurrenceNeoplasm Metastasis

Interventions

Surveys and QuestionnairesVideotape Recording

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic ProcessesNeoplastic ProcessesNeoplasms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthTape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Eduardo Bruera, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2015

First Posted

April 21, 2015

Study Start

April 30, 2015

Primary Completion

March 7, 2018

Study Completion

March 7, 2018

Last Updated

March 22, 2018

Record last verified: 2018-03

Locations

US(1)