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Completed

NCT Number: NCT04627077

Livestrong Cancer Institutes' Patient Reported Outcomes Study

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dell Seton Medical Center

Austin, Texas, 78701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Acronym: LCI PROs

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 13, 2020
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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