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NCT05055011 Clinical Trial

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

Malignant Solid Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05055011
Other study ID # 2019-1169
Secondary ID NCI-2021-0115920
Status Active, not recruiting
Phase
First received
Last updated
Start date December 3, 2020
Est. completion date December 31, 2026

Study information
Verified date April 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 110
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Electronic Health Record Review
Review of medical records
• Survey Administration
Complete survey

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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