Hematopoietic and Lymphoid Cell NeoplasmNCT05055011
Parental Attitudes and Beliefs Regarding Risks Associated With Opioid Use in Children With Cancer
An observational study of Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This study investigates parents' attitudes and beliefs on the risks of opioid use in children with cancer. Pain is the common symptom reported by pediatric cancer patients. Opioids are the mainstay in the treatment of cancer-related pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Electronic Health Record Review and Survey Administration
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2020to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parents whose children are on or have been on an opioid for cancer-related pain and parents whose children have not been on an opioid for cancer-related pain
Who may be able to join
- Parents must be at least 18 years old
- The parent must be able to understand, read, write, and speak English
- The parent must provide verbal informed consent
- The child of the parents must be 18 years old or younger
- The child must have a diagnosis of cancer
Who cannot join
- A non-cancer diagnosis (neurofibromatosis, Li-Fraumeni syndrome for example).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parental Attitudes and Beliefs Regarding Risks Associated With Opioid Use in Children
This study investigates parents' attitudes and beliefs on the risks of opioid use in children with cancer. Pain is the common symptom reported by pediatric cancer patients. Opioids are the mainstay in the treatment of cancer-related pain. Despite an almost universal desire to prevent or mitigate pain in their children, parents exhibit complex behaviors from withholding prescribed opioids entirely to giving less than the prescribed analgesic dose of opioid to discontinuing despite ongoing pain. Information gathered from this study may help address a crucial knowledge gap in researchers' understanding of parental attitudes and beliefs regarding the risks associated with opioid use in children and adolescents.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine parents' level of concern regarding the use of opioids for pain in their children.
SECONDARY OBJECTIVES:
- To explore differences in parents' level of concern regarding the use of opioids for pain in their children as well as level of concern for side effect of opioids between the opioid subgroup and non-opioid subgroup.
II. To explore differences in other parental attitudes and beliefs between the opioid subgroup and the non-opioid subgroup.
III. For each concern, associations between:
IIIa. Level of concern regarding the use of opioids and the age and disease of the child.
IIIb. Level of concern regarding the use of opioids and parental history of addiction.
IIIc. Level of concern regarding the use of opioids and a family history of addiction.
OUTLINE:
Parents complete survey over 20 minutes. Patients' medical records are reviewed.
- Being tested
- Electronic Health Record Review, Survey Administration
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health Record ReviewOther
Review of medical records
Survey AdministrationOther
Complete survey
| Study group | Role | What they receive |
|---|---|---|
| Observational (survey, medical record review) | Parents complete survey over 20 minutes. Patients' medical records are reviewed. Receives: Other: Electronic Health Record Review; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parents' level of concern regarding the use of opioids for pain in their children.
Will be summarized using proportion along with a 95% confidence interval in opioid subgroup and non-opioid subgroup separately.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start3 Dec 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies 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
- Cross-sectional
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Madden, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055011
- Sponsor's protocol ID
- 2019-1169
- Other IDs
- NCI-2021-01159, 2019-1169
- Status last verified
- Oct 2026
- First submitted
- 1 Mar 2021
- Last updated
- 7 Oct 2026
- 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 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Attitudes and Beliefs Regarding Risks Associated With Opioid Use in Children
- ClinicalTrials.gov ID
- NCT05055011
- Acronym / sponsor ID
- 2019-1169
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Sep 2021 (actual)
- 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.
This study investigates parents' attitudes and beliefs on the risks of opioid use in children with cancer. Pain is the common symptom reported by pediatric cancer patients. Opioids are the mainstay in the treatment of cancer-related pain. Despite an almost universal desire to prevent or mitigate pain in their children, parents exhibit complex behaviors from withholding prescribed opioids entirely to giving less than the prescribed analgesic dose of opioid to discontinuing despite ongoing pain. Information gathered from this study may help address a crucial knowledge gap in researchers' understanding of parental attitudes and beliefs regarding the risks associated with opioid use in children and adolescents.
Detailed description
PRIMARY OBJECTIVE:
- To determine parents' level of concern regarding the use of opioids for pain in their children.
SECONDARY OBJECTIVES:
- To explore differences in parents' level of concern regarding the use of opioids for pain in their children as well as level of concern for side effect of opioids between the opioid subgroup and non-opioid subgroup.
II. To explore differences in other parental attitudes and beliefs between the opioid subgroup and the non-opioid subgroup.
III. For each concern, associations between:
IIIa. Level of concern regarding the use of opioids and the age and disease of the child.
IIIb. Level of concern regarding the use of opioids and parental history of addiction.
IIIc. Level of concern regarding the use of opioids and a family history of addiction.
OUTLINE:
Parents complete survey over 20 minutes. Patients' medical records are reviewed.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (survey, medical record review) | – | Other: Electronic Health Record Review, Other: Survey AdministrationParents complete survey over 20 minutes. Patients' medical records are reviewed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parents whose children are on or have been on an opioid for cancer-related pain and parents whose children have not been on an opioid for cancer-related pain
Key inclusion criteria (5 listed)
- Parents must be at least 18 years old
- The parent must be able to understand, read, write, and speak English
- The parent must provide verbal informed consent
- The child of the parents must be 18 years old or younger
- The child must have a diagnosis of cancer
Key exclusion criteria (1 listed)
- A non-cancer diagnosis (neurofibromatosis, Li-Fraumeni syndrome for example).
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 |
|---|---|---|
| Electronic Health Record ReviewReview of medical records | Other | Observational (survey, medical record review) |
| Survey AdministrationComplete survey | Other | Observational (survey, medical record review) |
Primary outcome
Parents' level of concern regarding the use of opioids for pain in their children.
Time frame: through study completion, an average of 1 year
Will be summarized using proportion along with a 95% confidence interval in opioid subgroup and non-opioid subgroup separately.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- M D 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.
Kevin Madden, 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 Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, 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 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: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Parents' level of concern regarding the use of opioids for pain in their children. (time frame: through study completion, an average of 1 year). 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 7 Oct 2026.