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Clinical Trials/NCT05055011
NCT05055011
Active, not recruiting
Not Applicable

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

M.D. Anderson Cancer Center1 site in 1 country110 target enrollmentDecember 3, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hematopoietic and Lymphoid Cell Neoplasm
Sponsor
M.D. Anderson Cancer Center
Enrollment
110
Locations
1
Primary Endpoint
Parents' level of concern regarding the use of opioids for pain in their children.
Status
Active, not recruiting
Last Updated
6 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 3, 2020
End Date
December 31, 2026
Last Updated
6 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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).

Outcomes

Primary Outcomes

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.

Study Sites (1)

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