Identification of Anxiety and Depression in Adolescents/Young Adults (AYA) With Cancer

NCT04589052 | Completed

• 1 other identifier: STU-2019-1203
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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).

Conditions

Cancer; Depression, Anxiety

Outcome Measures

Primary Outcomes (1)

• Feasibility of a multi-site, multiple time-point psychosocial study for AYA with cancer

  * Hypothesis a: Greater than 50% of eligible patients will enroll and complete at least two time points in the study. * Hypothesis b: Enrollment and study completion rates will differ by site, with the site with the most psychosocial risk (low socioeconomic status as measured by insurance type (private, public, uninsured)) having the lowest enrollment and study completion rates. * Hypothesis c: Enrollment and study completion rates will differ by treatment type. Those receiving treatment that has the most frequent clinic/hospital visits (as measured by chemotherapy versus radiation only/surgery only) will have the highest completion rates.

  up to 12 months (+/- one 4 weeks) following enrollment

Secondary Outcomes (19)

• Correlation between hope and quality of life (QoL) in AYA cancer patients

  up to 12 months (+/- one 4 weeks) following enrollment

• Correlation between hope and social support (SS) in AYA cancer patients

  up to 12 months (+/- one 4 weeks) following enrollment

• Correlation between hope and anxiety and depression (A/D) in AYA cancer patients

  up to 12 months (+/- one 4 weeks) following enrollment

• Determine the impact of medical factors (treatment) on hope in AYA with cancer

  up to 12 months (+/- one 4 weeks) following enrollment

• Determine the impact of medical factors (treatment) on QoL in AYA with cancer

  up to 12 months (+/- one 4 weeks) following enrollment

Eligibility Criteria

• Age: 15 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents and young adults newly diagnosed as having a malignancy

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center / Children's Medical Center

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Neoplasms; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Julie Germann, Ph.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: October 19, 2020
• Study Start: October 5, 2020
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

US (1)