Livestrong Cancer Institutes' Patient Reported Outcomes Study (LCI PROs)

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms; Drug Therapy

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 Type: Observational
• Enrollment (Actual): 121

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78701
      • Dell Seton Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Total sample size of 200 adult patients and caregivers (n=200 dyads). Patients are currently receiving treatment for a cancer diagnosis at the Seton Infusion Center.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
SIC drug therapy patients; Patients with a cancer diagnosis currently being treated at SIC clinic

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Texas at Austin

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2018
• Primary Completion (Actual): January 25, 2019
• Study Completion (Actual): January 25, 2019

Study Registration Dates

• First Submitted: May 4, 2018
• First Submitted That Met QC Criteria: November 6, 2020
• First Posted (Actual): November 13, 2020

Study Record Updates

• Last Update Posted (Actual): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2017-08-0081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No