Attitudes and Believes About Vaccinations in a Supportive... | NCT05329506

Studies
Attitudes and Believes About Vaccinations in a Supportive Care Patient Population

NCT05329506

Sponsor

M.D. Anderson Cancer Center

Status

Completed

Last Update Posted

Jul 17, 2024Actual

Enrollment

104Actual

Phase

Not provided

Conditions

Vaccinations

Interventions

patient population

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2022-00365	Other Identifier	NCI-CTRP-Clinical Trial Reporting Registry

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2022Actual

Primary Completion Date

Jul 15, 2024Actual

Completion Date

Jul 15, 2024Actual

First Submitted Date

Mar 8, 2022

First Submission Date that Met QC Criteria

Apr 7, 2022

First Posted Date

Apr 15, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2024

Last Update Posted Date

Jul 17, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To learn about the attitudes and beliefs towards vaccination both before and after the COVID-19 pandemic in patients who have received supportive care.

Detailed Description

Primary Objective:

Our primary objective is to assess patient perception of efficacy and safety of vaccinations.

Secondary Objectives:

To assess demographic predictors of those who would be considered as vaccine hesitant.

To assess patient preferred source of recommendations for or against vaccination.

To assess the role past side effects or allergic reactions play on patient perception of future vaccines.

To assess patient perception of vaccination prior to COVID-19.

To assess patient willingness to get the COVID-19 vaccine.

To assess patient willingness to get the influenza vaccine.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

104Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Supportive care patient population		Attitudes and Believes About Vaccinations, questionnaires	Other: patient population

Interventions

Name	Type	Description	Arm Group Labels	Other Names
patient population	Other	questionnaires, standard of care	Supportive care patient population

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Exploratory survey evaluating the solely patient's opinions and perceptions regarding the safety and efficacy of vaccinations for Parent Attitudes about Childhood Vaccines (PACV-4 scale) with a score of 2 or greater.	We will assess the patient's opinion and perception of the safety of vaccinations based upon a questionnaire and a Likert scale of responses.	through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who are seen as part of a clinic visit with the Supportive Care Clinic at M.D.

Anderson Cancer Center, also patients who are being seen by the inpatient Supportive Medicine Consultation Service.
Patients who are 18 years of age or older
Patients who are able to speak English.

Exclusion Criteria:

Patients who are unable to sign written consent
Patients who are considered delirious at the time of the clinic encounter as defined by a Memorial Delirium Assessment Scale score of 7 or greater. The nursing staff, as a part of the patient intake process and routine care, performs the delirium assessment for clinic patients.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

M D Anderson Cancer Center

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Tang, MD	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
M D Anderson Cancer Center		Houston	Texas	77030	United States