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CancerNCT04589052

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

An observational study of Cancer and Depression, Anxiety, run by University of Texas Southwestern Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 15 to 29 years
Conditions the study is for
Cancer, Depression, Anxiety
How many people
57 participants
Where
1 siteUnited States
Study dates
5 Oct 2020to 1 Nov 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 29 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Adolescents and young adults newly diagnosed as having a malignancy

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UT Southwestern Medical Center / Children's Medical Center

    Dallas, Texas, 75235

Other trials in United States

About this study

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).

Read the 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.

Medical subject headings
Neoplasms, Depression, Anxiety Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (19)

  1. 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)

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

  2. 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)

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

  3. 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).

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

  4. 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)

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

  5. 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)

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

  6. 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)

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

  7. 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).

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

  8. 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)

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

  9. 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)

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

  10. 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)

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

  11. 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).

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

  12. 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)

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

  13. 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)

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

  14. 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)

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

  15. 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).

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

  16. 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)

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

  17. 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)

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

  18. 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)

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

  19. 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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2020
  2. Study start5 Oct 2020
  3. Primary completion1 Nov 2023
  4. Study completion1 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04589052
Sponsor's protocol ID
STU-2019-1203
Status last verified
Jan 2024
First submitted
21 Apr 2020
Last updated
31 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer and Depression, Anxiety, run by University of Texas Southwestern Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of a multi-site, multiple time-point psychosocial study for AYA with cancer (time frame: up to 12 months (+/- one 4 weeks) following enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04589052.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.

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