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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04589052
• Other study ID #: STU-2019-1203
• Status: Completed
• Start date: October 5, 2020
• Est. completion date: November 1, 2023

Study information

• Verified date: January 2024
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Cancer
• Depression
• Depression, Anxiety
• Depressive Disorder

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center / Children's Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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