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

NCT07484282 | Not Yet Recruiting

• 2 other identifiers: 10002546002546-C
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Patients Living With Stage IV or Recurrent Cancer

Keywords

End of life; surveys; quality of care; adolescent and young adults; Interviews

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

AYA Cancer Patients, Caregivers, Clinicians

AYA participants with advanced cancer and caregivers or clinicians for AYA patients with advanced cancer.

Other: Quality Assessment

Interventions

Quality Assessment OTHER

Participation in surveys, interviews and/or panels.

AYA Cancer Patients, Caregivers, Clinicians

Eligibility Criteria

• Age: 12 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Neoplasms; Recurrence; Death

Interventions

Quality Assurance, Health Care

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Lori S Wiener, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lori S Wiener, Ph.D.

CONTACT

(240) 760-6419; wienerl@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 20, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 2, 2026

Record last verified: 2026-03-17

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: This will be at the discretion of the Sponsor. At NIH, clinical data available during the study and indefinitely via BTRIS.
• 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.

Locations

US (1)