Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04751396
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2021-02-08
Brief Title:
Testing of an Educational Tool for Patients With Melanoma and Pre-Existing Autoimmune Disease Who Are Candidates for Immune Checkpoint Inhibitors
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Testing of an Educational Tool for Patients With Melanoma and Concomitant Autoimmune Disease Who Are Candidates for Adjuvant Therapy With Immune Checkpoint Inhibitors Acceptability and Usability With Patients and Providers
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study learn how easily patients can use an educational tool that will be created for patients with melanoma and pre-existing autoimmune diseases who receive or will receive immune checkpoint inhibitor drugs Patients will be asked their opinions about the design accessibility and content of the tool Researchers will use the information collected to improve the educational materials that will help patients make future decisions about their treatment
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the acceptability eg ease of use design accessibility content of the educational tool that will be developed for patients with melanoma and pre-existing autoimmune conditions considering or undergoing treatment with immune checkpoint inhibitors
II To test the usability in real world-settings of the educational tool to be developed and evaluate feasibility of patient recruitment ie ability to identify enough patients and consent at least 50 of the identified patients in a pilot study
OUTLINE
PART A Participants navigate the educational tool over 30-45 minutes then participate in an interview about their thoughts and opinions about the content ease of use and format of the tool over 45 minutes
PART B 2 group of participants will be evaluated sequentially Participants in group II will be enrolled after all the participants in group I have been assessed
GROUP I Patients receive standard educational information during their clinician encounter Patients also complete questionnaires over 30-45 minutes at baseline within a week prior to their clinician encounter immediately after the encounter and at 3 months
GROUP II Patients navigate educational tool over 20 minutes during their clinician encounter Patients also complete questionnaires over 30-45 minutes at baseline within a week prior to their clinician encounter immediately after the encounter and at 3 months
I To evaluate the acceptability eg ease of use design accessibility content of the educational tool that will be developed for patients with melanoma and pre-existing autoimmune conditions considering or undergoing treatment with immune checkpoint inhibitors
II To test the usability in real world-settings of the educational tool to be developed and evaluate feasibility of patient recruitment ie ability to identify enough patients and consent at least 50 of the identified patients in a pilot study
OUTLINE
PART A Participants navigate the educational tool over 30-45 minutes then participate in an interview about their thoughts and opinions about the content ease of use and format of the tool over 45 minutes
PART B 2 group of participants will be evaluated sequentially Participants in group II will be enrolled after all the participants in group I have been assessed
GROUP I Patients receive standard educational information during their clinician encounter Patients also complete questionnaires over 30-45 minutes at baseline within a week prior to their clinician encounter immediately after the encounter and at 3 months
GROUP II Patients navigate educational tool over 20 minutes during their clinician encounter Patients also complete questionnaires over 30-45 minutes at baseline within a week prior to their clinician encounter immediately after the encounter and at 3 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2021-00565 | REGISTRY | None | None |
| 2020-0843 | OTHER | None | None |
| K08CA237619 | NIH | M D Anderson Cancer Center | httpsreporternihgovquickSearchK08CA237619 |