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

• ClinicalTrials.gov Identifier: NCT03057639
• Recruitment Status: Recruiting
• First Posted: February 20, 2017
• Last Update Posted: October 25, 2019
• Sponsor: University of Southern California
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): University of Southern California

Tracking Information

• First Submitted Date: February 15, 2017
• First Posted Date: February 20, 2017
• Last Update Posted Date: October 25, 2019
• Actual Study Start Date: February 3, 2017
• Estimated Primary Completion Date: August 3, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 15, 2017)

• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 15, 2017)

• 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 ]
  Will be measured using an implementation guide.
• 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 ]
  Will be measured using an implementation guide.
• 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 ]
  Will be measured using an implementation guide.
• Satisfaction of health care staff as assessed by questionnaires (LAC+USC) [ Time Frame: Up to 2 years ]
  Questionnaire scores will be expressed as median values with 95% confidence intervals.
• Satisfaction of services as assessed by questionnaires (LAC+USC) [ Time Frame: Up to 2 years ]
  Questionnaire scores will be expressed as median values with 95% confidence intervals.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Model in Evaluating Clinical, Psychosocial, and Health Economic Factors in Adolescent and Young Adult Patients With Cancer
• 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
• 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.

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.

• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Malignant Neoplasm

Intervention

• Other: Quality-of-Life Assessment
  Ancillary studies
  Other Name: Quality of Life Assessment
• Other: Questionnaire Administration
  Ancillary studies

Study Groups/Cohorts

Observational (questionnaires)

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

Interventions:

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 15, 2017): 850
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 3, 2021
• Estimated Primary Completion Date: August 3, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 15 Years to 39 Years (Child, Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Terry Church; 323-865-3000; Terry.Church@med.usc.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03057639
• Other Study ID Numbers: 0S-16-6; NCI-2017-00210 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); 0S-16-6 ( Other Identifier: USC / Norris Comprehensive Cancer Center ); P30CA014089 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: University of Southern California
• Study Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: James Hu, MD; University of Southern California

• PRS Account: University of Southern California
• Verification Date: October 2019