Hematopoietic and Lymphoid Cell NeoplasmNCT04820894
Perception of Cure Among Patients With Metastatic Cancer
An observational study of Hematopoietic and Lymphoid Cell Neoplasm and Metastatic Malignant Solid Neoplasm, run by City of Hope Medical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Metastatic Malignant Solid Neoplasm
- What is being tested?
- Electronic Medical Record and Survey Administration
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2021to 5 Jan 2022
- 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: Patients with metastatic cancer
Eligibility Criteria:
- Patients must be aged 18 and over
- Patients sufficiently fluent in English
- Patients must have a cytologically or pathologically verified diagnosis of cancer
- Patients must have measurable metastatic disease
- Patients must be initiating immunotherapy
- Patients must be undergoing evaluation and treatment at City of Hope Cancer Center
About this study
Official title: The Perception of Cure Among Patients With Metastatic Cancer
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess the proportion of patients with metastatic cancer who anticipate cure before starting immunotherapy.
SECONDARY OBJECTIVES:
- To determine if expectations of cure are associated with quality of life and distress.
II. To determine if patients' perceptions differ by gender, age, and ethnicity.
OUTLINE:
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.
- Being tested
- Electronic Medical Record, Survey Administration
- Medical subject headings
- Hematologic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Medical RecordOther
Also called Computer Based Patient Record, EMR, EMR (electronic medical record)
Medical records are reviewed
Survey AdministrationOther
Complete surveys
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Electronic Medical Record; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start30 Oct 2021
- Primary completion5 Jan 2022
- Study completion5 Jan 2022
Why it stopped: Feasibility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sumanta K Pal, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820894
- Sponsor's protocol ID
- 19322
- Other IDs
- NCI-2021-01818, 19322, P30CA033572
- Status last verified
- May 2025
- First submitted
- 25 Mar 2021
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Perception of Cure Among Patients With Metastatic Cancer
- ClinicalTrials.gov ID
- NCT04820894
- Acronym / sponsor ID
- 19322
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Feasibility
- Enrolment
- 0 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Oct 2021 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 29 Mar 2021 (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.
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.
Detailed description
PRIMARY OBJECTIVE:
- To assess the proportion of patients with metastatic cancer who anticipate cure before starting immunotherapy.
SECONDARY OBJECTIVES:
- To determine if expectations of cure are associated with quality of life and distress.
II. To determine if patients' perceptions differ by gender, age, and ethnicity.
OUTLINE:
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (survey, medical records review) | – | Other: Electronic Medical Record, Other: Survey AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Medical RecordAlso: Computer Based Patient Record, EMR, EMR (electronic medical record)Medical records are reviewed | Other | Observational (survey, medical records review) |
| Survey AdministrationComplete surveys | Other | Observational (survey, medical records review) |
Primary outcome
Percentage of patients
Time frame: Up to 2 years
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.
Patient Reported Outcomes Measurement Information System (PROMIS)
Time frame: Up to 2 years
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.
Functional Assessment of Cancer Therapy-General (FACT-G)
Time frame: Up to 2 years
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.
Perceptions of cure
Time frame: Up to 2 years
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).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
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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.
Sumanta K Pal principal investigator
City of Hope Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic and Lymphoid Cell Neoplasm and Metastatic Malignant Solid Neoplasm, run by City of Hope Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Percentage of patients (time frame: Up to 2 years). The study lists 4 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 23 May 2025.