Clinical trial NCT04627077: Livestrong Cancer Institutes' Patient Reported Outcomes Study
Official title: Livestrong Cancer Institutes' Patient Reported Outcomes Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Drug Therapy
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Quality of Life - FACT-G
timeFrame: Baseline
measure: Change in Anxiety - PROMIS
timeFrame: Baseline and 3 month follow up
measure: Change in Depression - PROMIS
timeFrame: Baseline and 3 month follow up
measure: Change in Pain - PROMIS
timeFrame: Baseline and 3 month follow up
measure: Change in Physical Function- PROMIS
timeFrame: Baseline and 3 month follow up
measure: Change in Fatigue - PROMIS
timeFrame: Baseline and 3 month follow up
measure: Change in Financial Toxicity
timeFrame: Baseline and 3 month follow up
measure: Change in Patient satisfaction with care
timeFrame: Baseline and 3 month follow up
Secondary outcomes:
measure: Change in Impact on Caregivers
timeFrame: Baseline and 3 month follow up
Other outcomes:
Locations:
city: Austin
country: United States
facility: Dell Seton Medical Center
state: Texas
Study officials:
References: