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TerminatedNCT03057639Updated Jul 25, 2025

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

An observational study in Malignant Neoplasm, sponsored by University of Southern California. Terminated at 1 site in United States. Open to participants aged 15 Years to 39 Years. Per ClinicalTrials.gov, last updated 2025-07-25.

Sponsored by University of Southern California · Observational

Why this study was terminated
Slow accrual
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
76
Ages
15 Years to 39 Years
Sex
All
01

Study summary

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:

I. 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)

V. 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.

02

Conditions studied

  • Malignant Neoplasm

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 76 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.

Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 39 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
76 participants (actual)

Groups and cohorts

  • Observational (questionnaires)

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

    Other: Quality-of-Life Assessment · Other: Questionnaire Administration

Interventions

  • OtherQuality-of-Life Assessment

    Ancillary studies

    Also known as: Quality of Life Assessment

  • OtherQuestionnaire Administration

    Ancillary studies

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 2 years

  2. 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.

    Time frame: Up to 2 years

  3. 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

    Time frame: Up to 2 years

  4. 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.

    Time frame: Up to 2 years

  5. 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.

    Time frame: Up to 2 years

Secondary outcomes

  1. 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.

    Time frame: Up to 2 years

  2. 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.

    Time frame: Up to 2 years

  3. 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.

    Time frame: Up to 2 years

  4. Satisfaction of health care staff as assessed by questionnaires (LAC+USC)

    Questionnaire scores will be expressed as median values with 95% confidence intervals.

    Time frame: Up to 2 years

  5. Satisfaction of services as assessed by questionnaires (LAC+USC)

    Questionnaire scores will be expressed as median values with 95% confidence intervals.

    Time frame: Up to 2 years

07

Study locations

1 site
  • USC / Norris Comprehensive Cancer Center
    Los Angeles, California 90033, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03057639
Lead sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Feb 20, 2017
Start date
Feb 3, 2017
Primary completion
Nov 30, 2021
Completion
Jun 17, 2025
Last update
Jul 25, 2025

Study contacts

James Hu, MD
principal investigator · University of Southern California

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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