Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05763797
Status:
RECRUITING
Last Update Posted:
2024-02-01
First Post:
2023-02-28
Brief Title:
Developing a Culturally Relevant Supportive Care Program for Black Patients Dealing With Advanced Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Developing a Culturally Relevant Supportive Care Program for Black Patients Dealing With Advanced Cancer
Status:
RECRUITING
Status Verified Date:
2024-07
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:
To determine the feasibility of implementing a culturally adapted mind-body intervention Meditation-Based Support-Adapted MBS-A as a supportive care strategy in Black patients diagnosed with a stage III-IV solid malignancy To target the specific needs of Black advanced cancer patients we will first conduct formative research that includes quantitative surveys and in-depth interviews of patients and their primary caregivers The purpose of this formative research is to determine the intervention format for the MBS-A program family- vs group-based that promises the greatest likelihood of success and to solicit input on the original MBS intervention regarding content that needs adaptation Once the intervention format is determined and content adapted we will conduct a pilot randomized controlled trial RCT to examine the feasibility of the MBS-A intervention vs a dose-matched attention control AC group receiving a psychoeducation intervention
Detailed Description:
Primary Objectives
The purpose of this RCT is to thoroughly determine the feasibility of the overall RCT design as well as specific intervention procedures in this underserved population to inform if a large efficacy trial is warranted Our results will lead to future NIH R01 applications in which efficacy and mechanisms of the interventions will be tested using fully powered samples of Black patients with advanced cancer including multicenter trials The long-term goal is to establish the effectiveness of the MBS-A intervention and widely disseminate the intervention Ultimately the intervention is intended to improve cancer control and reduce the double disparity in this underserved patient population
We propose the following specific aims
1 Systematically and culturally adapt a meditation-based support intervention MBS-A and finalize the intervention components and delivery format that meet the needs of Black patients with advanced cancer
2 Identify the feasibility of conducting a supportive-care RCT in Black patients with advanced cancer as determined by recruitment and retention rates randomization and blinding procedures and intervention delivery
3 Identify the feasibility of implementing the MBS-A and AC interventions as determined by session attendance intervention acceptability and treatment fidelity
The purpose of this RCT is to thoroughly determine the feasibility of the overall RCT design as well as specific intervention procedures in this underserved population to inform if a large efficacy trial is warranted Our results will lead to future NIH R01 applications in which efficacy and mechanisms of the interventions will be tested using fully powered samples of Black patients with advanced cancer including multicenter trials The long-term goal is to establish the effectiveness of the MBS-A intervention and widely disseminate the intervention Ultimately the intervention is intended to improve cancer control and reduce the double disparity in this underserved patient population
We propose the following specific aims
1 Systematically and culturally adapt a meditation-based support intervention MBS-A and finalize the intervention components and delivery format that meet the needs of Black patients with advanced cancer
2 Identify the feasibility of conducting a supportive-care RCT in Black patients with advanced cancer as determined by recruitment and retention rates randomization and blinding procedures and intervention delivery
3 Identify the feasibility of implementing the MBS-A and AC interventions as determined by session attendance intervention acceptability and treatment fidelity
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-2023-01995 | OTHER | NCI-CTRP Clinical Trials Registry | None |