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

NCT ID: NCT04589052

Last Updated: 2024-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-05

Study Completion Date

2023-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Depression, Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Julie Germann

Associate Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Julie Germann, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UT Southwestern Medical Center / Children's Medical Center

Dallas, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STU-2019-1203

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Depression and Adherence in Head and Neck Cancer
NCT00498875 ACTIVE_NOT_RECRUITING
Personality and Cancer Care Study
NCT04625439 COMPLETED NA