NCT04820894

Brief Summary

This study collects information about perception of cure among patients with cancer that has spread to other places in the body (metastatic). This study aims to determine patients' perception (knowledge) before starting immunotherapy and if differences exist in understanding of treatment to stimulate or restore the ability of the body's immune (defense) system to fight infection and disease (immunotherapy) based on social and economic factors or on race/ethnicity.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

October 30, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2022

Completed
Last Updated

May 23, 2025

Status Verified

May 1, 2025

Enrollment Period

2 months

First QC Date

March 25, 2021

Last Update Submit

May 22, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Percentage of patients

    Will assess the percentage of patients who anticipate cure before starting immunotherapy, scoring a '1' on the Perception of cure tool, and anticipate \>75% chance for a cure.

    Up to 2 years

  • Patient Reported Outcomes Measurement Information System (PROMIS)

    Descriptive analyses (e.g. frequency statistics) will be used to characterize the sample and to look at the association between Patient Reported Outcomes Measurement Information System (PROMIS) tool score with perception of cure score.

    Up to 2 years

  • Functional Assessment of Cancer Therapy-General (FACT-G)

    Descriptive analyses (e.g. frequency statistics) will be used to characterize the sample and to look at the association between Functional Assessment of Cancer Therapy-General (FACT-G) overall score with perception of cure score.

    Up to 2 years

  • Perceptions of cure

    Chi-square analyses will be used to examine perceptions of cure by sociodemographic characteristics: gender (male and female), age (\< 60 and \> 60), and ethnicity (white non-Hispanic, Hispanic, and other).

    Up to 2 years

Study Arms (1)

Observational (survey, medical records review)

Patients complete surveys over 30 minutes about sociodemographic information and perception of immunotherapy, over 10 minutes about expectations of cure, over 10 minutes about anxiety, over 10 minutes about depression, and over 30 minutes about physical well-being. Patients' medical records are reviewed.

Other: Electronic Medical RecordOther: Survey Administration

Interventions

Medical records are reviewed

Also known as: Computer Based Patient Record, EMR, EMR (electronic medical record)
Observational (survey, medical records review)

Complete surveys

Observational (survey, medical records review)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with metastatic cancer

Eligibility Criteria: 1. Patients must be aged 18 and over 2. Patients sufficiently fluent in English 3. Patients must have a cytologically or pathologically verified diagnosis of cancer 4. Patients must have measurable metastatic disease 5. Patients must be initiating immunotherapy 6. Patients must be undergoing evaluation and treatment at City of Hope Cancer Center

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Hematologic NeoplasmsNeoplasm Metastasis

Interventions

Electronic Health Records

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Medical Records Systems, ComputerizedMedical RecordsRecordsData CollectionEpidemiologic MethodsInvestigative TechniquesOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Sumanta K Pal

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2021

First Posted

March 29, 2021

Study Start

October 30, 2021

Primary Completion

January 5, 2022

Study Completion

January 5, 2022

Last Updated

May 23, 2025

Record last verified: 2025-05