Quality of Care for Adolescent and Young Adult (AYA) Patients Living With Serious or Advanced Cancer

April 1, 2026 updated by: National Cancer Institute (NCI)

Background:

Cancer among adolescents and young adults (AYAs) is on the rise, with nearly 90,000 AYAs diagnosed in the US each year. While most are cured, an estimated 15,000 AYAs die of cancer in the US annually creating profound suffering for those whose lives are cut short and for those who survive them. AYAs face unique challenges near the end of life (EOL). The tragic circumstances surrounding young lives cut short by cancer often provoke intensive efforts to prolong life, sometimes at the cost of comfort and quality. Patients, families, and even clinicians experience these deaths as tragic, a departure from the natural order of life in which each generation outlives the one before it.

The current study is designed to ensure future efforts to improve care is guided by patient perspectives. The aims of the study are to 1) measure the quality of care received by adolescents and young adults (AYAs) living with advanced cancer using patient-centered quality measures, focusing specifically on potential unmet psychosocial, spiritual, and communication needs and 2) to assess disparities in end-of-life (EOL) care quality and barriers to care experienced by Black, Asian, and Hispanic AYAs. Our research will enable us to answer remaining critically unanswered questions and unmet needs about EOL care quality and barriers to care experienced by AYAs.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Objectives:

  • Aim 1: To measure the quality of care received by adolescents and young adults (AYAs) living with advanced cancer using patient-centered quality measures.

    • Hypothesis 1.1: AYAs experience high unmet need for psychosocial and spiritual care and communication.
    • Hypothesis 1.2: Unmet needs for care of physical and psychosocial symptoms intensify over time.

  • Aim 2: To assess disparities in end-of-life (EOL) care quality and barriers to care experienced by Black, Asian, and Hispanic AYAs.

    • Hypothesis 2.1: Black, Asian, and Hispanic AYAs are at risk for inferior quality care relative to White patients, with areas of greatest disparity in attention to physical symptoms and communication.
    • Hypothesis 2.2: Black, Asian, and Hispanic AYAs experience unique barriers to high-quality EOL care, including structural, interpersonal, and individual factors, as well as culturally informed influences.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

adolescent and young adult patients 12-39 years old. Caregivers and clinicians 18yrs and older

Description

  • ELIGIBILITY CRITERIA:
  • Stakeholder Panel:

Patients

  • Ages 12-39y, inclusive
  • English- or Spanish-speaking and reading
  • Living with stage IV or recurrent cancer

Caregivers

  • Must be actively involved in the care of an AYA patient
  • English- or Spanish-speaking and reading

Clinicians

  • Must care for AYA patients

  • Can be of any discipline, including oncologists, nurses, social workers, psychologists, and chaplains.

    -Surveys and Interviews (Aims 1 and 2):

  • Patients ages 12-39y, inclusive
  • English- or Spanish-speaking and reading
  • Living with stage IV or recurrent cancer

Survey Notes: 1) For AYAs <18y, family caregivers will be asked to respond to survey questions. For AYAs >=18y, family caregiver participation is optional. 2) Patients will be eligible without respect to timing of diagnosis or recurrence as long as they are living with advanced disease.

Interview Notes: 1) Survey participants will be eligible at the time of completion of the final survey; AYAs who did not participate in surveys (e.g., if enrollment to the survey cohort is already complete) will also be eligible. 2) Patients will be eligible without respect to timing of diagnosis or recurrence as long as they are living with advanced disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AYA Cancer Patients, Caregivers, Clinicians
AYA participants with advanced cancer and caregivers or clinicians for AYA patients with advanced cancer.
Other: Quality Assessment
Participation in surveys, interviews and/or panels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aim 1: To measure the quality of care received by adolescents and young adults (AYAs) living with advanced cancer using patient-centered quality measures.
Time Frame: 3 years
The primary outcome is patient-centered quality of care in the 7 quality domains from our survey. We will generate descriptive data on the proportion of AYAs who report high quality care in each domain, defined as responses in the top 2 categories for each question (for example, that the care team supported quality of life extremely or very well).
3 years
Aim 2: To assess disparities in EOL care quality and barriers to care experienced by minority AYAs
Time Frame: 3 years
We will use logistic regression to evaluate associations between care quality and race/ethnicity in each of the 7 quality domains, adjusting for potential confounders such as age, sex, gender identity, socioeconomic status, site, and diagnosis.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Lori S Wiener, Ph.D., National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 7, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

March 19, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10002546
  • 002546-C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

This study will comply with the NIH Data Management and Sharing (DMS) Policy, as approved or waived by the Center for Cancer Research (NIH ICO).

IPD Sharing Time Frame

This will be at the discretion of the Sponsor. At NIH, clinical data available during the study and indefinitely via BTRIS.

IPD Sharing Access Criteria

This will be at the discretion of the Sponsor. At NIH, clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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