NCT05055011

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Dec 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress91%
Dec 2020Dec 2026

Study Start

First participant enrolled

December 3, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2021

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 23, 2021

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

6.1 years

First QC Date

March 1, 2021

Last Update Submit

April 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    through study completion, an average of 1 year

Study Arms (1)

Observational (survey, medical record review)

Parents complete survey over 20 minutes. Patients' medical records are reviewed.

Other: Electronic Health Record ReviewOther: Survey Administration

Interventions

Review of medical records

Observational (survey, medical record review)

Complete survey

Observational (survey, medical record review)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • A non-cancer diagnosis (neurofibromatosis, Li-Fraumeni syndrome for example).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Kevin Madden, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2021

First Posted

September 23, 2021

Study Start

December 3, 2020

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations