CancerNCT07484282
Quality of Care for Adolescent and Young Adult (AYA) Patients Living With Serious or Advanced Cancer
An observational study of Cancer and Patients Living With Stage IV or Recurrent Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 120 years
- Conditions the study is for
- Cancer, Patients Living With Stage IV or Recurrent Cancer
- What is being tested?
- Quality Assessment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2026to 1 Apr 2029
- 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 12 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read the 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.
- Being tested
- Quality Assessment
- Keywords
- End of life, surveys, quality of care, adolescent and young adults, Interviews
- Medical subject headings
- Neoplasms, Recurrence, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality AssessmentOther
Participation in surveys, interviews and/or panels.
| Study group | Role | What they receive |
|---|---|---|
| AYA Cancer Patients, Caregivers, Clinicians | AYA participants with advanced cancer and caregivers or clinicians for AYA patients with advanced cancer. Receives: Other: Quality Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start7 Apr 2026 (estimated)
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Apr 2029 (estimated)
Why it stopped: This record was submitted inadvertently and was not intended for registration, as NIH is not the responsible party and the study is not an applicable clinical trial. As PRS does not permit deletion, the record has been marked as withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lori S Wiener, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484282
- Sponsor's protocol ID
- 10002546
- Other IDs
- 002546-C
- Status last verified
- Apr 2026
- First submitted
- 19 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Care for Adolescent and Young Adult (AYA) Patients Living With Serious or Advanced Cancer
- ClinicalTrials.gov ID
- NCT07484282
- Acronym / sponsor ID
- 10002546
- Keywords
- End of life, surveys, quality of care, adolescent and young adults, Interviews
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: This record was submitted inadvertently and was not intended for registration, as NIH is not the responsible party and the study is not an applicable clinical trial. As PRS does not permit deletion, the record has been marked as withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 7 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AYA Cancer Patients, Caregivers, Clinicians | – | Other: Quality AssessmentAYA participants with advanced cancer and caregivers or clinicians for AYA patients with advanced cancer. |
Who may qualify
- Ages
- 12 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- adolescent and young adult patients 12-39 years old. Caregivers and clinicians 18yrs and older
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality AssessmentParticipation in surveys, interviews and/or panels. | Other | AYA Cancer Patients, Caregivers, Clinicians |
Primary outcome
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).
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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).
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori S Wiener, Ph.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Patients Living With Stage IV or Recurrent Cancer, run by National Cancer Institute (NCI) 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?
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: withdrawn, as of the sponsor's last update on 3 Apr 2026. 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 was withdrawn before enrolling participants, so there are no results.
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?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2026.