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

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• Status: Withdrawn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: Cancer; Patients Living With Stage IV or Recurrent Cancer
• Intervention / Treatment: Other: Quality Assessment

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

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.	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	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

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

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

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: quality of care; Interviews; surveys; End of life; adolescent and young adults
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Neoplasms; Recurrence; Death; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Assurance, Health Care
• 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