Clinical trial NCT05055011: Parental Attitudes and Beliefs Regarding Risks Associated With Opioid Use in Children With Cancer
Official title: Parental Attitudes and Beliefs Regarding Risks Associated With Opioid Use in Children
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-09-23
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_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

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.

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).

Primary outcomes:
measure: Parents' level of concern regarding the use of opioids for pain in their children.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Kevin Madden, MD
role: PRINCIPAL_INVESTIGATOR
References: