Malignant NeoplasmNCT03057639

Clinical Model in Evaluating Clinical, Psychosocial, and Health Economic Factors in Adolescent and Young Adult Patients With Cancer

An observational study of Malignant Neoplasm, run by University of Southern California at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 15 to 39 years
Conditions the study is for: Malignant Neoplasm
What is being tested?: Quality-of-Life Assessment and Questionnaire Administration
How many people: 76 participants
Where: 1 siteUnited States
Study dates: 3 Feb 2017to 17 Jun 2025
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 15 to 39 years
All sexes
No healthy volunteers
Child, Adult

Study population: Adolescent and Young Adult (AYA) with cancer who are being seen at the USC/Norris Cancer Center and at LAC+USC Medical Center.

Who may be able to join

Patients diagnosed with cancer
ADDITIONAL GRANT SPECIFIC INCLUSION CRITERIA - UNIHEALTH (NORRIS):
Patients who were diagnosed at USC Norris Comprehensive Cancer Center and Hospital
Patients who are currently receiving treatment for a primary or secondary tumor at USC Norris Comprehensive Cancer Center and Hospital
ADDITIONAL GRANT SPECIFIC INCLUSION CRITERIA - QUEENSCARE (LAC + USC):
Patients who are being seen in sarcoma, gynecologic oncology, or genitourinary clinic at LAC + USC (clinics A2C or 4P1)
Patients who are currently receiving treatment for a primary or secondary tumor at LAC + USC and who receive oncology care from one of the clinics above
Patients who are at or below the poverty level

Who cannot join

Inability to sign informed assent and/or consent
Patients who are not receiving chemotherapy and/or radiation therapy for a primary or secondary tumor
Primary oncology treatment team believes that participation in AYA at USC would not benefit their patient
ADDITIONAL GRANT SPECIFIC EXCLUSION CRITERIA - UNIHEALTH (NORRIS):
Patients who are not receiving treatment for a primary or secondary tumor at USC Norris Comprehensive Cancer Center and Hospital
ADDITIONAL GRANT SPECIFIC EXCLUSION CRITERIA - QUEENSCARE (LAC+USC):
Patients who are not receiving oncology care for a primary or secondary tumor in sarcoma, gynecologic oncology, or genitourinary clinic at LAC + USC (clinics A2C or 4P1)
Patients who are above the poverty level

Trial locations and contacts

1 site in 1 country.

United States1 site

USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033

Other trials in United States

About this study

Official title: Adolescent and Young Adult (AYA) Cancers Clinical Model: An Evaluation of the AYA Clinical Care Model by Assessment of Clinical, Psychosocial, and Health Economic Factors Related to AYA Patient Outcomes

This research trial studies the Adolescent and Young Adult (AYA) Cancers Clinical Model in evaluating clinical, psychosocial, and health economic factors in adolescent and young adult patients with cancer. Studying the Adolescent and Young Adult Cancers Clinical Model may help doctors learn more about the effect of the AYA services on patient care, including clinical (nurse navigation), psychosocial (social work), and economic (financial) areas.

Read the detailed description

PRIMARY OBJECTIVES:

To provide economic understanding of the AYA at University of Southern California (USC) model of care. (Norris)

II. To evaluate the existing AYA at USC program to determine the direct and indirect impact on cost of care. (Norris)

III. To utilize the results of objective (i) to identify cost effectiveness and efficiencies to patient and institution. (Norris)

IV. To identify specific processes within our model of care that can be improved. (Norris)

To improve healthcare access to AYA-specific cancer care for patients ages 15-39 served by the Los Angeles County (LAC)+USC oncology pilot clinics. (LAC+USC)

VI. To improve the psychosocial outcome of AYA-specific cancer care patients. (LAC+USC)

VII. To provide AYA specific elements of care routinely and proactively to AYA cancer patients. (LAC+USC)

VIII. To improve care quality through patient satisfaction. (LAC+USC)

IX. To improve resource utilization and care coordination through improved patient navigation through efficiency and patient navigation. (LAC+USC)

OUTLINE:

Patients complete questionnaires at referral, week 4-8, week 10-12, and at the completion of systemic therapy.

Conditions: Malignant Neoplasm
Being tested: Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies

Study groups in NCT03057639
Study group	Role	What they receive
Observational (questionnaires)		Patients complete questionnaires at referral, week 4-8, week 10-12, and at the completion of systemic therapy. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical care model impact on patient access to AYA specific supportive care as assessed by questionnaires (Norris)
Questionnaire scores will be expressed as median values with 95% confidence intervals.
Measured: Up to 2 years
Clinical care model impact on patient's/health care professional's satisfaction with the AYA at USC program as assessed by questionnaires (LAC+USC)
Questionnaire scores will be expressed as median values with 95% confidence intervals.
Measured: Up to 2 years
Cost of care (Norris)
Direct health care costs analyses will be performed from the Total Costs of Care payer perspective. Direct cost will be estimated from paid claims in the extracted electronic medical records, which will include costs for all health care utilization such as outpatient, procedures, laboratory, emergency room visits, hospitalization, and pharmacy. As the healthcare utilization and costs will likely be extremely skewed, healthcare utilization and cost measures will be estimated by using an econometric model (e.g., a negative binomial regression model for utilization count data [number of services
Measured: Up to 2 years
Incremental cost (Norris)
The incremental cost between AYA enrolled and non-enrolled will be calculated. In addition to estimation the magnitude of the variability attributed to the different sources of variation, we will also generate an influence diagram (also known as tornado diagram) to display which variables exert the most influence on cost driver.
Measured: Up to 2 years
Processes that can be improved (Norris)
Will utilize the prospective data to estimate key aspects of the AYA at USC service. Any variances in the services over time will be utilized to improve quality and reliability care delivery.
Measured: Up to 2 years

Secondary outcomes (5)

Care coordination as assessed by the mean number of supportive care referrals, telephone or email encounters for additional information, educational materials, and or additional interventions provided by the nurse navigator and/or social worker (LAC+USC)
Will be measured using an implementation guide.
Measured: Up to 2 years
Patient continuity of care as assessed by the mean number of visits per patient with the assigned clinic lead physician (LAC+USC)
Will be measured using an implementation guide.
Measured: Up to 2 years
Resource allocation as assessed by the mean number of supportive care referrals and per patient follow-up conducted by the nurse navigator and/or social worker (LAC+USC)
Will be measured using an implementation guide.
Measured: Up to 2 years
Satisfaction of health care staff as assessed by questionnaires (LAC+USC)
Questionnaire scores will be expressed as median values with 95% confidence intervals.
Measured: Up to 2 years
Satisfaction of services as assessed by questionnaires (LAC+USC)
Questionnaire scores will be expressed as median values with 95% confidence intervals.
Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Feb 201717 Jun 2025

First posted20 Feb 2017
Study start3 Feb 2017
Primary completion30 Nov 2021
Study completion17 Jun 2025

Why it stopped: Slow accrual

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
More trials run by University of Southern CaliforniaThe 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: Case only
Time perspective: Prospective
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03057639
Sponsor's protocol ID: 0S-16-6
Other IDs: NCI-2017-00210, 0S-16-6, P30CA014089
Status last verified: Jul 2025
First submitted: 15 Feb 2017
Last updated: 25 Jul 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 3
Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Nonfunctional Neuroendocrine Neoplasms
Neuroendocrine Neoplasm, Gastroenteropancreatic Neuroendocrine Neoplasm

All Malignant Neoplasm trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adolescent and Young Adult (AYA) Cancers Clinical Model: An Evaluation of the AYA Clinical Care Model by Assessment of Clinical, Psychosocial, and Health Economic Factors Related to AYA Patient Outcomes
ClinicalTrials.gov ID: NCT03057639
Acronym / sponsor ID: 0S-16-6
Conditions: Malignant Neoplasm
Study type: Observational
Recruitment status: TerminatedReason stopped: Slow accrual
Enrolment: 76 participants (actual)
Lead sponsor: University of Southern CaliforniaUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 3 Feb 2017 (actual)
Primary completion: 30 Nov 2021 (actual)
Study completion: 17 Jun 2025 (actual)
First posted: 20 Feb 2017 (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.

Detailed description

PRIMARY OBJECTIVES:

To provide economic understanding of the AYA at University of Southern California (USC) model of care. (Norris)

II. To evaluate the existing AYA at USC program to determine the direct and indirect impact on cost of care. (Norris)

III. To utilize the results of objective (i) to identify cost effectiveness and efficiencies to patient and institution. (Norris)

IV. To identify specific processes within our model of care that can be improved. (Norris)

To improve healthcare access to AYA-specific cancer care for patients ages 15-39 served by the Los Angeles County (LAC)+USC oncology pilot clinics. (LAC+USC)

VI. To improve the psychosocial outcome of AYA-specific cancer care patients. (LAC+USC)

VII. To provide AYA specific elements of care routinely and proactively to AYA cancer patients. (LAC+USC)

VIII. To improve care quality through patient satisfaction. (LAC+USC)

IX. To improve resource utilization and care coordination through improved patient navigation through efficiency and patient navigation. (LAC+USC)

OUTLINE:

Patients complete questionnaires at referral, week 4-8, week 10-12, and at the completion of systemic therapy.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Observational (questionnaires)	–	Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients complete questionnaires at referral, week 4-8, week 10-12, and at the completion of systemic therapy.

Who may qualify

Ages: 15 to 39 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult
Study population: Adolescent and Young Adult (AYA) with cancer who are being seen at the USC/Norris Cancer Center and at LAC+USC Medical Center.

Key inclusion criteria (8 listed)

Patients diagnosed with cancer
ADDITIONAL GRANT SPECIFIC INCLUSION CRITERIA - UNIHEALTH (NORRIS):
Patients who were diagnosed at USC Norris Comprehensive Cancer Center and Hospital
Patients who are currently receiving treatment for a primary or secondary tumor at USC Norris Comprehensive Cancer Center and Hospital
ADDITIONAL GRANT SPECIFIC INCLUSION CRITERIA - QUEENSCARE (LAC + USC):

Key exclusion criteria (8 listed)

Inability to sign informed assent and/or consent
Patients who are not receiving chemotherapy and/or radiation therapy for a primary or secondary tumor
Primary oncology treatment team believes that participation in AYA at USC would not benefit their patient
ADDITIONAL GRANT SPECIFIC EXCLUSION CRITERIA - UNIHEALTH (NORRIS):
Patients who are not receiving treatment for a primary or secondary tumor at USC Norris Comprehensive Cancer Center and Hospital

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-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies	Other	Observational (questionnaires)
Questionnaire AdministrationAncillary studies	Other	Observational (questionnaires)

Primary outcome

Clinical care model impact on patient access to AYA specific supportive care as assessed by questionnaires (Norris)
Time frame: Up to 2 years
Questionnaire scores will be expressed as median values with 95% confidence intervals.
Clinical care model impact on patient's/health care professional's satisfaction with the AYA at USC program as assessed by questionnaires (LAC+USC)
Time frame: Up to 2 years
Questionnaire scores will be expressed as median values with 95% confidence intervals.
Cost of care (Norris)
Time frame: Up to 2 years
Direct health care costs analyses will be performed from the Total Costs of Care payer perspective. Direct cost will be estimated from paid claims in the extracted electronic medical records, which will include costs for all health care utilization such as outpatient, procedures, laboratory, emergency room visits, hospitalization, and pharmacy. As the healthcare utilization and costs will likely be extremely skewed, healthcare utilization and cost measures will be estimated by using an econometric model (e.g., a negative binomial regression model for utilization count data [number of services
Incremental cost (Norris)
Time frame: Up to 2 years
The incremental cost between AYA enrolled and non-enrolled will be calculated. In addition to estimation the magnitude of the variability attributed to the different sources of variation, we will also generate an influence diagram (also known as tornado diagram) to display which variables exert the most influence on cost driver.
Processes that can be improved (Norris)
Time frame: Up to 2 years
Will utilize the prospective data to estimate key aspects of the AYA at USC service. Any variances in the services over time will be utilized to improve quality and reliability care delivery.

5 secondary outcomes

Care coordination as assessed by the mean number of supportive care referrals, telephone or email encounters for additional information, educational materials, and or additional interventions provided by the nurse navigator and/or social worker (LAC+USC)
Time frame: Up to 2 years
Patient continuity of care as assessed by the mean number of visits per patient with the assigned clinic lead physician (LAC+USC)
Time frame: Up to 2 years
Resource allocation as assessed by the mean number of supportive care referrals and per patient follow-up conducted by the nurse navigator and/or social worker (LAC+USC)
Time frame: Up to 2 years
Satisfaction of health care staff as assessed by questionnaires (LAC+USC)
Time frame: Up to 2 years
Satisfaction of services as assessed by questionnaires (LAC+USC)
Time frame: Up to 2 years

Results and safety

The study was stopped early (reason given: Slow accrual). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.

Related trials for Malignant Neoplasm

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
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 3
Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Nonfunctional Neuroendocrine Neoplasms
Neuroendocrine Neoplasm, Gastroenteropancreatic Neuroendocrine Neoplasm

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.

James Hu, MD principal investigator

University of Southern California

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 Malignant Neoplasm, run by University of Southern California 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?

The sponsor lists 8 inclusion and 8 exclusion criteria. 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: stopped early, as of the sponsor's last update on 25 Jul 2025. 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 stopped early (reason given: Slow accrual). Results are not available in the source record.

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?

Clinical care model impact on patient access to AYA specific supportive care as assessed by questionnaires (Norris) (time frame: Up to 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03057639.

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 25 Jul 2025.