Advanced CancersNCT02422329
Changes in Patient Reported Constipation Among Advanced Cancer Patients After Receiving an Educational Intervention
A study testing Questionnaires, Video and Fact Sheet in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this research study is to learn how patients' think about constipation before and after receiving education about the subject. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- Questionnaires, Video and Fact Sheet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2015to 7 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this research study is to learn how patients' think about constipation before and after receiving education about the subject.
Read the 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.
- Conditions
- Advanced Cancers
- Being tested
- Questionnaires, Video, Fact Sheet
- Keywords
- Advanced Cancers, Constipation, Recurrent cancer, Locally advanced cancer, Metastatic cancer, Video, Fact sheet, Questionnaires, Surveys
- Medical subject headings
- Constipation, Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Also called Surveys
Participants complete questionnaires at baseline and after intervention.
VideoBehavioural
Participants watch a 3-minute educational video describing symptoms of constipation and importance of regular bowel movements.
Fact SheetBehavioural
Participants read educational material describing symptoms of constipation and importance of regular bowel movements.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Questionnaires; Behavioral: 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. Receives: Behavioral: Questionnaires; Behavioral: Fact Sheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study start30 Apr 2015
- Primary completion7 Mar 2018
- Study completion7 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduardo Bruera, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422329
- Sponsor's protocol ID
- 2015-0111
- Other IDs
- NCI-2015-00734
- Status last verified
- Mar 2018
- First submitted
- 16 Apr 2015
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Patient Reported Constipation Among Advanced Cancer Patients After Receiving an Educational Intervention
- ClinicalTrials.gov ID
- NCT02422329
- Acronym / sponsor ID
- 2015-0111
- Conditions
- Advanced Cancers
- Keywords
- Advanced Cancers, Constipation, Recurrent cancer, Locally advanced cancer, Metastatic cancer, Video, Fact sheet, Questionnaires
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 30 Apr 2015 (actual)
- Primary completion
- 7 Mar 2018 (actual)
- Study completion
- 7 Mar 2018 (actual)
- First posted
- 21 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Video | Experimental | Behavioral: Questionnaires, Behavioral: VideoParticipants 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. |
| Fact Sheet | Experimental | Behavioral: Questionnaires, Behavioral: Fact SheetParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesAlso: SurveysParticipants complete questionnaires at baseline and after intervention. | Behavioural | Educational Video, Fact Sheet |
| VideoParticipants watch a 3-minute educational video describing symptoms of constipation and importance of regular bowel movements. | Behavioural | Educational Video |
| Fact SheetParticipants read educational material describing symptoms of constipation and importance of regular bowel movements. | Behavioural | Fact Sheet |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Bruera, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires, Video and Fact Sheet in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Perception of Constipation (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2018; AzTrials last refreshed its copy on 6 Nov 2026.