Livestrong Cancer Institutes' Patient Reported Outcomes Study

Study Overview
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Brief Summary
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The goal of this study will be to collect baseline patient reported outcome measures at the Livestrong Cancer Institutes (LCI) with the goal of improving quality care and to inform decision making by patients, providers, and researchers for future LCI initiatives.

Detailed Description
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This proposed study is a descriptive study of the adult oncology population at the Seton Infusion Center in order to provide information about patient needs and identify areas for further research and resource allocation. The patient reported outcome measures being collected cover the following domains: anxiety, depression, fatigue, physical function, financial toxicity and pain. Patients and caregivers will be informed about the study and given the opportunity to enroll at the time of routine clinic visits at the Dell Seton Medical Center at The University of Texas Seton Infusion Center (SIC). Patients choosing to enroll in the study will be provided informed consent, and then allowed to complete the measures during their clinic visit on an iPad provided by the research staff. After IRB approval for a period of 1-2 months data collection will take place at the SIC clinic at DMS. Upon completion of the measures patients will be asked for an email address and phone number so that a follow up link to survey questions can be sent to them in 3 months.

Official Title
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Livestrong Cancer Institutes' Patient Reported Outcomes Study

Conditions
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Neoplasms, Drug Therapy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged 18 years and older, being treated for cancer at the Seton Infusion Clinic Patient cognitively and physically able to complete questionnaires on an ipad in English or Spanish. Exclusion Criteria: -Patient unable to speak English or Spanish as required for study data collection Patient cognitively or physically unable to complete measures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SIC drug therapy patients<br>Patients with a cancer diagnosis currently being treated at SIC clinic | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life - FACT-G | Functional Assessment of Cancer Therapy (FACT-G) | Baseline | 
| Change in Anxiety - PROMIS | PROMIS adaptive anxiety | Baseline and 3 month follow up | 
| Change in Depression - PROMIS | PROMIS adaptive Depression | Baseline and 3 month follow up | 
| Change in Pain - PROMIS | PROMIS adaptive pain | Baseline and 3 month follow up | 
| Change in Physical Function- PROMIS | PROMIS adaptive physical function | Baseline and 3 month follow up | 
| Change in Fatigue - PROMIS | PROMIS adaptive fatigue | Baseline and 3 month follow up | 
| Change in Financial Toxicity | Comprehensive Score for financial Toxicity (COST) questionnaire | Baseline and 3 month follow up | 
| Change in Patient satisfaction with care | The CAHPS® Cancer Care Survey | Baseline and 3 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Impact on Caregivers | Brief Assessment Scale for Caregivers (BASC), range -27 to 12, higher scores poorer outcomes | Baseline and 3 month follow up |