Parental Attitudes and Beliefs Regarding Risks Associated... | NCT05055011

ID	Type	Description	Link
NCI-2021-01159	Registry Identifier	CTRP (Clinical Trial Reporting Program)
2019-1169	Other Identifier	M D Anderson Cancer Center

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 3, 2020Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Mar 1, 2021

First Submission Date that Met QC Criteria

Sep 14, 2021

First Posted Date

Sep 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2026

Last Update Posted Date

May 4, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

PRIMARY OBJECTIVE:

I. To determine parents' level of concern regarding the use of opioids for pain in their children.

SECONDARY OBJECTIVES:

I. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational (survey, medical record review)		Parents complete survey over 20 minutes. Patients' medical records are reviewed.	Other: Electronic Health Record Review Other: Survey Administration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Electronic Health Record Review	Other	Review of medical records	Observational (survey, medical record review)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kevin Madden, MD	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
M D Anderson Cancer Center		Houston	Texas	77030	United States

References Module

Citations

Not provided

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases