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

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).

Study Overview

• Status: Completed
• Conditions: Cancer; Depression, Anxiety

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.

• Study Type: Observational
• Enrollment (Actual): 57

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • UT Southwestern Medical Center / Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 29 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adolescents and young adults newly diagnosed as having a malignancy

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between hope and quality of life (QoL) in AYA cancer patients	- Hypothesis a: Hope (as measured by Snyder's (1991) Hope Scale, higher scores indicate higher hope) will be positively correlated to QoL (Pediatric Quality of Life Inventory 3.0 - Cancer Module, PedsQL, Varni, 2002; higher scores indicate better quality of life)	up to 12 months (+/- one 4 weeks) following enrollment
Correlation between hope and social support (SS) in AYA cancer patients	- Hypothesis a: Hope (as measured by Snyder's (1991) Hope Scale, higher scores indicate higher hope) will be positively correlated to SS (Multidimensional Perceived Social Support Scale (MPSSS; Zimet, Dahlem, Zimet, Farley, 1988); higher scores indicate higher social support)	up to 12 months (+/- one 4 weeks) following enrollment
Correlation between hope and anxiety and depression (A/D) in AYA cancer patients	- Hypothesis a: Hope (as measured by Snyder's (1991) Hope Scale, higher scores indicate higher hope) will be inversely correlated to A/D (The Four-Item Patient Health Questionnaire for Anxiety and Depression (PHQ-4; Kroenke, Spitzer, Williams, & Löwe, B. (2009); higher scores indicate greater symptoms of anxiety/depression).	up to 12 months (+/- one 4 weeks) following enrollment
Determine the impact of medical factors (treatment) on hope in AYA with cancer	- Hypothesis a: Medical severity (type of treatment (chemotherapy, surgery, radiation) will be inversely related to hope (The Hope Scale (Snyder et al., 1991); higher scores indicate greater hope)	up to 12 months (+/- one 4 weeks) following enrollment
Determine the impact of medical factors (treatment) on QoL in AYA with cancer	- Hypothesis a: Medical severity (type of treatment (chemotherapy, surgery, radiation) will be inversely related to QoL (Pediatric Quality of Life Inventory 3.0 - Cancer Module (Varni, Burwinkle, Katz, Meeske, & Dickinson, 2002); higher scores indicate greater quality of life)	up to 12 months (+/- one 4 weeks) following enrollment
Determine the impact of medical factors (treatment) on AD in AYA with cancer	- Hypothesis a: Medical severity (type of treatment (chemotherapy, surgery, radiation) will be positively related to A/D (The Four-Item Patient Health Questionnaire for Anxiety and Depression (PHQ-4; Kroenke, Spitzer, Williams, & Löwe, B. (2009); higher scores indicate greater symptoms of anxiety/depression)	up to 12 months (+/- one 4 weeks) following enrollment
Determine the impact of medical factors (treatment) on SS in AYA with cancer	- Hypothesis a: Medical severity (type of treatment (chemotherapy, surgery, radiation) will be inversely related to SS (Multidimensional Perceived Social Support Scale (MPSSS; Zimet, Dahlem, Zimet, Farley, 1988); higher scores indicate greater social support).	up to 12 months (+/- one 4 weeks) following enrollment
Determine the impact of socieconomic status on hope in AYA with cancer	- Hypothesis a: SES as indicated by insurance status will be inversely related to hope (The Hope Scale (Snyder et al., 1991); higher scores indicate greater hope)	up to 12 months (+/- one 4 weeks) following enrollment
Determine the impact of socieconomic status on QOL in AYA with cancer	- Hypothesis a: SES as indicated by insurance status will be inversely related to QoL (Pediatric Quality of Life Inventory 3.0 - Cancer Module (Varni, Burwinkle, Katz, Meeske, & Dickinson, 2002); higher scores indicate greater quality of life)	up to 12 months (+/- one 4 weeks) following enrollment
Determine the impact of socieconomic status on AD in AYA with cancer	- Hypothesis a: SES as indicated by insurance status will be positively related to A/D (The Four-Item Patient Health Questionnaire for Anxiety and Depression (PHQ-4; Kroenke, Spitzer, Williams, & Löwe, B. (2009); higher scores indicate greater symptoms of anxiety/depression)	up to 12 months (+/- one 4 weeks) following enrollment
Determine the impact of socieconomic status on SS in AYA with cancer	- Hypothesis a: SES as indicated by insurance status will be inversely related to SS (Multidimensional Perceived Social Support Scale (MPSSS; Zimet, Dahlem, Zimet, Farley, 1988); higher scores indicate greater social support).	up to 12 months (+/- one 4 weeks) following enrollment
Determine the impact sex on hope in AYA with cancer	- Hypothesis a: sex will be inversely related to hope (The Hope Scale (Snyder et al., 1991); higher scores indicate greater hope)	up to 12 months (+/- one 4 weeks) following enrollment
Determine the impact sex on QoL in AYA with cancer	- Hypothesis a: sex will be inversely related to QoL (Pediatric Quality of Life Inventory 3.0 - Cancer Module (Varni, Burwinkle, Katz, Meeske, & Dickinson, 2002); higher scores indicate greater quality of life)	up to 12 months (+/- one 4 weeks) following enrollment
Determine the impact sex on AD in AYA with cancer	- Hypothesis a: sex will be positively related to A/D (The Four-Item Patient Health Questionnaire for Anxiety and Depression (PHQ-4; Kroenke, Spitzer, Williams, & Löwe, B. (2009); higher scores indicate greater symptoms of anxiety/depression)	up to 12 months (+/- one 4 weeks) following enrollment
Determine the impact sex on SS in AYA with cancer	- Hypothesis a: sex will be inversely related to SS (Multidimensional Perceived Social Support Scale (MPSSS; Zimet, Dahlem, Zimet, Farley, 1988); higher scores indicate greater social support).	up to 12 months (+/- one 4 weeks) following enrollment
Determine the impact of age on hope in AYA with cancer	- Hypothesis a: age will be inversely related to hope (The Hope Scale (Snyder et al., 1991); higher scores indicate greater hope)	up to 12 months (+/- one 4 weeks) following enrollment
Determine the impact of age on QoL in AYA with cancer	- Hypothesis a: age will be inversely related to QoL (Pediatric Quality of Life Inventory 3.0 - Cancer Module (Varni, Burwinkle, Katz, Meeske, & Dickinson, 2002); higher scores indicate greater quality of life)	up to 12 months (+/- one 4 weeks) following enrollment
Determine the impact of age on AD in AYA with cancer	- Hypothesis a: age will be positively related to A/D (The Four-Item Patient Health Questionnaire for Anxiety and Depression (PHQ-4; Kroenke, Spitzer, Williams, & Löwe, B. (2009); higher scores indicate greater symptoms of anxiety/depression)	up to 12 months (+/- one 4 weeks) following enrollment
Determine the impact of age on SS in AYA with cancer	- Hypothesis a: age will be inversely related to SS (Multidimensional Perceived Social Support Scale (MPSSS; Zimet, Dahlem, Zimet, Farley, 1988); higher scores indicate greater social support).	up to 12 months (+/- one 4 weeks) following enrollment

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Julie Germann, Ph.D., University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2020
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: October 8, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: STU-2019-1203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No