NeoplasmsLCI PROsNCT04627077
Livestrong Cancer Institutes' Patient Reported Outcomes Study
An observational study of Neoplasms and Drug Therapy, run by University of Texas at Austin at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Drug Therapy
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2018to 25 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- -Patient unable to speak English or Spanish as required for study data collection
- Patient cognitively or physically unable to complete measures
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Conditions
- Neoplasms, Drug Therapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SIC drug therapy patients | Patients with a cancer diagnosis currently being treated at SIC clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life - FACT-G
Functional Assessment of Cancer Therapy (FACT-G)
Measured: Baseline
Change in Anxiety - PROMIS
PROMIS adaptive anxiety
Measured: Baseline and 3 month follow up
Change in Depression - PROMIS
PROMIS adaptive Depression
Measured: Baseline and 3 month follow up
Change in Pain - PROMIS
PROMIS adaptive pain
Measured: Baseline and 3 month follow up
Change in Physical Function- PROMIS
PROMIS adaptive physical function
Measured: Baseline and 3 month follow up
Change in Fatigue - PROMIS
PROMIS adaptive fatigue
Measured: Baseline and 3 month follow up
Change in Financial Toxicity
Comprehensive Score for financial Toxicity (COST) questionnaire
Measured: Baseline and 3 month follow up
Change in Patient satisfaction with care
The CAHPS® Cancer Care Survey
Measured: Baseline and 3 month follow up
Secondary outcomes (1)
Change in Impact on Caregivers
Brief Assessment Scale for Caregivers (BASC), range -27 to 12, higher scores poorer outcomes
Measured: Baseline and 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start22 Jan 2018
- Primary completion25 Jan 2019
- Study completion25 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gail Eckhardt, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627077
- Sponsor's protocol ID
- 2017-08-0081
- Acronym
- LCI PROs
- Status last verified
- Nov 2020
- First submitted
- 4 May 2018
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Livestrong Cancer Institutes' Patient Reported Outcomes Study
- ClinicalTrials.gov ID
- NCT04627077
- Acronym / sponsor ID
- LCI PROs / 2017-08-0081
- Conditions
- Neoplasms, Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 25 Jan 2019 (actual)
- Study completion
- 25 Jan 2019 (actual)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SIC drug therapy patients | – | –Patients with a cancer diagnosis currently being treated at SIC clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- -Patient unable to speak English or Spanish as required for study data collection
- Patient cognitively or physically unable to complete measures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Quality of Life - FACT-G
Time frame: Baseline
Functional Assessment of Cancer Therapy (FACT-G)
Change in Anxiety - PROMIS
Time frame: Baseline and 3 month follow up
PROMIS adaptive anxiety
Change in Depression - PROMIS
Time frame: Baseline and 3 month follow up
PROMIS adaptive Depression
Change in Pain - PROMIS
Time frame: Baseline and 3 month follow up
PROMIS adaptive pain
Change in Physical Function- PROMIS
Time frame: Baseline and 3 month follow up
PROMIS adaptive physical function
Change in Fatigue - PROMIS
Time frame: Baseline and 3 month follow up
PROMIS adaptive fatigue
Change in Financial Toxicity
Time frame: Baseline and 3 month follow up
Comprehensive Score for financial Toxicity (COST) questionnaire
Change in Patient satisfaction with care
Time frame: Baseline and 3 month follow up
The CAHPS® Cancer Care Survey
1 secondary outcome
Change in Impact on Caregivers
Time frame: Baseline and 3 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms and Drug Therapy, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life - FACT-G (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.