Parental Attitudes and Beliefs Regarding Risks Associated With Opioid Use in Children With Cancer

Active, not recruiting

• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
• Interventions: Other: Electronic Health Record Review; Other: Survey Administration

• Registration Number: NCT05055011
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-12-03
• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-09-14
• Study First Posted: 2021-09-23
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 110

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Parents' level of concern regarding the use of opioids for pain in their children.	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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States