Livestrong Cancer Institutes' Patient Reported Outcomes Study

Completed

• Conditions: Neoplasms; Drug Therapy

• Registration Number: NCT04627077
• Lead Sponsor: University of Texas at Austin

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-01-22
• Study First Submitted: 2018-05-04
• Primary Completion: 2019-01-25
• Study Completion: 2019-01-25
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-06
• Last Update Submitted: 2020-11-06
• Study First Posted: 2020-11-13
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dell Seton Medical Center; 🇺🇸 Austin, Texas, United States