Livestrong Cancer Institutes' Patient Reported Outcomes Study

NCT04627077 | Completed

• 1 other identifier: 2017-08-0081
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms; Drug Therapy

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Change in Impact on Caregivers

  Baseline and 3 month follow up

Study Arms (1)

SIC drug therapy patients

Patients with a cancer diagnosis currently being treated at SIC clinic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patient unable to speak English or Spanish as required for study data collection
• Patient cognitively or physically unable to complete measures

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Dell Seton Medical Center

Austin, Texas, 78701, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, LIVESTRONG Cancer Institutes Chair, Department of Oncology

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: November 13, 2020
• Study Start: January 22, 2018
• Primary Completion: January 25, 2019
• Study Completion: January 25, 2019
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)