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

Terminated

• Conditions: Malignant Neoplasm
• Interventions: Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT03057639
• Lead Sponsor: University of Southern California

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-02-03
• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-02-15
• Study First Posted: 2017-02-20
• Primary Completion: 2021-11-30
• Study Completion: 2021-11-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-05
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 76

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (questionnaires)	Questionnaire Administration	Patients complete questionnaires at referral, week 4-8, week 10-12, and at the completion of systemic therapy.
Observational (questionnaires)	Quality-of-Life Assessment	Patients complete questionnaires at referral, week 4-8, week 10-12, and at the completion of systemic therapy.

Primary Outcome Measures

Name	Time	Method
Clinical care model impact on patient's/health care professional's satisfaction with the AYA at USC program as assessed by questionnaires (LAC+USC)	Up to 2 years	Questionnaire scores will be expressed as median values with 95% confidence intervals.
Processes that can be improved (Norris)	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.
Cost of care (Norris)	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)	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.
Clinical care model impact on patient access to AYA specific supportive care as assessed by questionnaires (Norris)	Up to 2 years	Questionnaire scores will be expressed as median values with 95% confidence intervals.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

USC / Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States