Livestrong Cancer Institutes' Patient Reported Outcomes Study

Neoplasms Clinical Trial

— LCI PROs  

Official title:

Livestrong Cancer Institutes' Patient Reported Outcomes Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04627077
• Other study ID #: 2017-08-0081
• Status: Completed
• Start date: January 22, 2018
• Est. completion date: January 25, 2019

Study information

• Verified date: November 2020
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: January 25, 2019
• Est. primary completion date: January 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Therapy
• Neoplasms

Locations

Country	Name	City	State
United States	Dell Seton Medical Center	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

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