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

• ClinicalTrials.gov Identifier: NCT04627077
• Recruitment Status: Completed
• First Posted: November 13, 2020
• Last Update Posted: November 13, 2020
• Sponsor: University of Texas at Austin
• Information provided by (Responsible Party): Gail Eckhardt, University of Texas at Austin

Study Description

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.

Condition or disease
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 Design

• Study Type: Observational
• Actual Enrollment: 121 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Livestrong Cancer Institutes' Patient Reported Outcomes Study
• Actual Study Start Date: January 22, 2018
• Actual Primary Completion Date: January 25, 2019
• Actual Study Completion Date: January 25, 2019

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Change in Quality of Life - FACT-G [ Time Frame: Baseline ]
   Functional Assessment of Cancer Therapy (FACT-G)
2. Change in Anxiety - PROMIS [ Time Frame: Baseline and 3 month follow up ]
   PROMIS adaptive anxiety
3. Change in Depression - PROMIS [ Time Frame: Baseline and 3 month follow up ]
   PROMIS adaptive Depression
4. Change in Pain - PROMIS [ Time Frame: Baseline and 3 month follow up ]
   PROMIS adaptive pain
5. Change in Physical Function- PROMIS [ Time Frame: Baseline and 3 month follow up ]
   PROMIS adaptive physical function
6. Change in Fatigue - PROMIS [ Time Frame: Baseline and 3 month follow up ]
   PROMIS adaptive fatigue
7. Change in Financial Toxicity [ Time Frame: Baseline and 3 month follow up ]
   Comprehensive Score for financial Toxicity (COST) questionnaire
8. Change in Patient satisfaction with care [ Time Frame: Baseline and 3 month follow up ]
   The CAHPS® Cancer Care Survey

Secondary Outcome Measures :

1. Change in Impact on Caregivers [ Time Frame: Baseline and 3 month follow up ]
   Brief Assessment Scale for Caregivers (BASC), range -27 to 12, higher scores poorer outcomes

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

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

Contacts and Locations

Locations

United States, Texas

Dell Seton Medical Center

Austin, Texas, United States, 78701

Sponsors and Collaborators

University of Texas at Austin

More Information

• Responsible Party: Gail Eckhardt, Director, LIVESTRONG Cancer Institutes Chair, Department of Oncology, University of Texas at Austin
• ClinicalTrials.gov Identifier: NCT04627077
• Other Study ID Numbers: 2017-08-0081
• First Posted: November 13, 2020
• Last Update Posted: November 13, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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