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

NCT03057639 | Terminated DMC

• 3 other identifiers: 0S-16-6NCI-2017-00210P30CA014089
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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

  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.

  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.

  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)

  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)

  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)

  Up to 2 years

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

  Up to 2 years

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

  Up to 2 years

Study Arms (1)

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

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Observational (questionnaires)

Questionnaire Administration OTHER

Ancillary studies

Observational (questionnaires)

Eligibility Criteria

• Age: 15 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Patients diagnosed with cancer
• 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
• 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

You may not qualify if:

• 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
• Patients who are not receiving treatment for a primary or secondary tumor at USC Norris Comprehensive Cancer Center and Hospital
• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• James Hu, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 20, 2017
• Study Start: February 3, 2017
• Primary Completion: November 30, 2021
• Study Completion: June 17, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

US (1)