Malignant Neoplasms of Independent (Primary) Multiple SitesNCT03043378
Chronic Non-Malignant Pain in Cancer Patients at a Supportive Care Clinic
An observational study of Malignant Neoplasms of Independent (Primary) Multiple Sites, 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 frequently cancer patients in the Supportive Care Center have chronic, non-malignant pain. Chronic, non-malignant pain is pain that is neither related to cancer nor its treatment and lasts beyond the normal tissue healing time of 3 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasms of Independent (Primary) Multiple Sites
- What is being tested?
- Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2018to 23 Mar 2023
- Phase
- Observational
- 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
Study population: Participants undergoing consultation at the Supportive Care Clinic at MD Anderson Cancer Center.
Who may be able to join
- Diagnosis of cancer with or without active disease
- Consultation visit at an outpatient supportive care clinic
- Age 18 or greater
- Report of having pain within the last 3 months
Who cannot join
- 1) Memorial Delirium Assessment Scale >13
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 frequently cancer patients in the Supportive Care Center have chronic, non-malignant pain. Chronic, non-malignant pain is pain that is neither related to cancer nor its treatment and lasts beyond the normal tissue healing time of 3 months.
Read the detailed description
If participant is found to be eligible and agrees to take part in this study, participant will be asked to complete 3 questionnaires about participant's pain, pain level, and what drugs participant takes to treat participant's pain. Participant will also be asked a few questions about tobacco use. These questionnaires should take about 20 minutes to complete.
Researchers will also collect information from participant's medical record such as participant's date of birth, sex, race, marital status, economic background, and medical history.
Length of Study:
Participation on this study will be over after participant has completed the last questionnaire.
This is an investigational study.
Up to 200 participants will be enrolled in this study. All will take part at MD Anderson.
- Being tested
- Questionnaires
- Keywords
- Malignant Neoplasms of Independent (Primary) Multiple Sites, Non-malignant pain, Supportive care, Questionnaires, Surveys, Chronic non-malignant pain
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 three questionnaires at consultation visit.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Non-Malignant Pain - Cancer Patients | Chronic non-malignant pain among cancer patients undergoing a consultation at the outpatient Supportive Care Clinic at MD Anderson Cancer Center. Receives: Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Chronic Non-Malignant Pain Among Cancer Patients
Frequency assessed by Edmonton Symptom Assessment Scale (ESAS-FS)
Measured: 1 day
Frequency of Chronic Non-Malignant Pain Among Cancer Patients
Frequency assessed by Brief Pain Inventory.
Measured: 1 day
Frequency of Chronic Non-Malignant Pain Among Cancer Patients
Frequency assessed by the Charlson Comorbidity Index.
Measured: 1 day
Frequency of Chronic Non-Malignant Pain Among Cancer Patients
Frequency assessed by Pain Characteristic Survey.
Measured: 1 days
Frequency of Chronic Non-Malignant Pain Among Cancer Patients
Frequency assessed by Karnofsky Performance Scale.
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 posted6 Feb 2017 (estimated)
- Study start31 Jul 2018
- Primary completion23 Mar 2023
- Study completion23 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasms of Independent (Primary) Multiple SitesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Hui, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043378
- Sponsor's protocol ID
- 2016-0901
- Other IDs
- NCI-2018-01268
- Status last verified
- Mar 2023
- First submitted
- 2 Feb 2017
- Last updated
- 28 Mar 2023
- 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 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Non-Malignant Pain in Cancer Patients at a Supportive Care Clinic
- ClinicalTrials.gov ID
- NCT03043378
- Acronym / sponsor ID
- 2016-0901
- Keywords
- Malignant Neoplasms of Independent (Primary) Multiple Sites, Non-malignant pain, Supportive care, Questionnaires, Surveys, Chronic non-malignant pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 6 Feb 2017 (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 frequently cancer patients in the Supportive Care Center have chronic, non-malignant pain. Chronic, non-malignant pain is pain that is neither related to cancer nor its treatment and lasts beyond the normal tissue healing time of 3 months.
Detailed description
If participant is found to be eligible and agrees to take part in this study, participant will be asked to complete 3 questionnaires about participant's pain, pain level, and what drugs participant takes to treat participant's pain. Participant will also be asked a few questions about tobacco use. These questionnaires should take about 20 minutes to complete.
Researchers will also collect information from participant's medical record such as participant's date of birth, sex, race, marital status, economic background, and medical history.
Length of Study:
Participation on this study will be over after participant has completed the last questionnaire.
This is an investigational study.
Up to 200 participants will be enrolled in this study. All will take part at MD Anderson.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Non-Malignant Pain - Cancer Patients | – | Behavioral: QuestionnairesChronic non-malignant pain among cancer patients undergoing a consultation at the outpatient Supportive Care Clinic at MD Anderson Cancer Center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants undergoing consultation at the Supportive Care Clinic at MD Anderson Cancer Center.
Key inclusion criteria (4 listed)
- Diagnosis of cancer with or without active disease
- Consultation visit at an outpatient supportive care clinic
- Age 18 or greater
- Report of having pain within the last 3 months
Key exclusion criteria (1 listed)
- 1) Memorial Delirium Assessment Scale >13
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 three questionnaires at consultation visit. | Behavioural | Chronic Non-Malignant Pain - Cancer Patients |
Primary outcome
Frequency of Chronic Non-Malignant Pain Among Cancer Patients
Time frame: 1 day
Frequency assessed by Edmonton Symptom Assessment Scale (ESAS-FS)
Frequency of Chronic Non-Malignant Pain Among Cancer Patients
Time frame: 1 day
Frequency assessed by Brief Pain Inventory.
Frequency of Chronic Non-Malignant Pain Among Cancer Patients
Time frame: 1 day
Frequency assessed by the Charlson Comorbidity Index.
Frequency of Chronic Non-Malignant Pain Among Cancer Patients
Time frame: 1 days
Frequency assessed by Pain Characteristic Survey.
Frequency of Chronic Non-Malignant Pain Among Cancer Patients
Time frame: 1 day
Frequency assessed by Karnofsky Performance Scale.
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 28 Mar 2023.
- 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.
David Hui, 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?
An observational study of Malignant Neoplasms of Independent (Primary) Multiple Sites, 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 4 inclusion and 1 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 28 Mar 2023. 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?
Frequency of Chronic Non-Malignant Pain Among Cancer Patients (time frame: 1 day). The study lists 5 primary outcomes in all. 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 28 Mar 2023.