Clinical trial NCT04589052: Identification of Anxiety and Depression in Adolescents/Young Adults (AYA) With Cancer
Official title: Identification of Anxiety and Depression in Adolescents/Young Adults (AYA) With Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Depression, Anxiety
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 57
Sex: ALL
Minimum age (years): 15
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents and young adults newly diagnosed as having a malignancy

Brief summary: This is a prospective, multisite (but all within the UTSW IRB), observational study assessing the relationship of hope to anxiety and depression, QoL, and social support over time in the first year after cancer diagnosis or relapse in AYA (ages 15-29 years of age).

Detailed description: The principal investigators' ongoing work suggests hope is a target for intervention to improve quality of life (QoL) and reduce anxiety and depression (A/D) among adolescents/young adults (AYA). No study to the investigators' knowledge has evaluated the promising impact of hope interventions in AYA cancer patients. To address this gap, the investigators will expand the investigators' prior research on hope, A/D, and QoL to AYA receiving care across three diverse healthcare systems.

Patients will be approached for participation within 3 months of their initial/relapse cancer diagnosis. Eligible patients (and the parent/caregiver for minor patients) will be approached in a private area of the clinic or hospital room to explain the research aims and informed consent process. After obtaining informed consent/assent (from parents if patients are under 18, from AYA if patient is 18 or older), participants (patients) will utilize an iPad to complete measures via Redcap.

Eligibility criteria: Inclusion Criteria:

* Adolescents and young adults (15-17, 18-29 years of age, respectively) with a new or relapse diagnosis of a malignancy
* Patients will include those being followed (treatment or observational) for any malignant disorder at Children's Medical Center, UT Southwestern Medical Center, or Parkland Health and Hospital Systems
* Patients whose native language is Spanish or English are eligible to participate
* Patients may have any life expectancy
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Patients with clinically apparent cognitive disabilities which would preclude understanding and completion of measures.
* Patients with significant medical issues such as delirium which preclude their ability to consent and complete initial measures

Primary outcomes:
measure: Feasibility of a multi-site, multiple time-point psychosocial study for AYA with cancer
timeFrame: up to 12 months (+/- one 4 weeks) following enrollment
Secondary outcomes:
measure: Correlation between hope and quality of life (QoL) in AYA cancer patients
timeFrame: up to 12 months (+/- one 4 weeks) following enrollment
measure: Correlation between hope and social support (SS) in AYA cancer patients
timeFrame: up to 12 months (+/- one 4 weeks) following enrollment
measure: Correlation between hope and anxiety and depression (A/D) in AYA cancer patients
timeFrame: up to 12 months (+/- one 4 weeks) following enrollment
measure: Determine the impact of medical factors (treatment) on hope in AYA with cancer
timeFrame: up to 12 months (+/- one 4 weeks) following enrollment
measure: Determine the impact of medical factors (treatment) on QoL in AYA with cancer
timeFrame: up to 12 months (+/- one 4 weeks) following enrollment
measure: Determine the impact of medical factors (treatment) on AD in AYA with cancer
timeFrame: up to 12 months (+/- one 4 weeks) following enrollment
measure: Determine the impact of medical factors (treatment) on SS in AYA with cancer
timeFrame: up to 12 months (+/- one 4 weeks) following enrollment
measure: Determine the impact of socieconomic status on hope in AYA with cancer
timeFrame: up to 12 months (+/- one 4 weeks) following enrollment
measure: Determine the impact of socieconomic status on QOL in AYA with cancer
timeFrame: up to 12 months (+/- one 4 weeks) following enrollment
measure: Determine the impact of socieconomic status on AD in AYA with cancer
timeFrame: up to 12 months (+/- one 4 weeks) following enrollment
measure: Determine the impact of socieconomic status on SS in AYA with cancer
timeFrame: up to 12 months (+/- one 4 weeks) following enrollment
measure: Determine the impact sex on hope in AYA with cancer
timeFrame: up to 12 months (+/- one 4 weeks) following enrollment
measure: Determine the impact sex on QoL in AYA with cancer
timeFrame: up to 12 months (+/- one 4 weeks) following enrollment
measure: Determine the impact sex on AD in AYA with cancer
timeFrame: up to 12 months (+/- one 4 weeks) following enrollment
measure: Determine the impact sex on SS in AYA with cancer
timeFrame: up to 12 months (+/- one 4 weeks) following enrollment
measure: Determine the impact of age on hope in AYA with cancer
timeFrame: up to 12 months (+/- one 4 weeks) following enrollment
measure: Determine the impact of age on QoL in AYA with cancer
timeFrame: up to 12 months (+/- one 4 weeks) following enrollment
measure: Determine the impact of age on AD in AYA with cancer
timeFrame: up to 12 months (+/- one 4 weeks) following enrollment
measure: Determine the impact of age on SS in AYA with cancer
timeFrame: up to 12 months (+/- one 4 weeks) following enrollment
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center / Children's Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Julie Germann, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: