Developing a Culturally Relevant Supportive Care Program for Black Patients Dealing With Advanced Cancer
Running, not enrolling · Not applicable
Conditions studied: Cancer
In brief
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.
Key facts
- Study ID
- NCT05763797
- Run by
- M.D. Anderson Cancer Center
- People needed
- 170
- Starts
- 2023-04-13
- Expected to finish
- 2029-03-31
- Last updated by the study team
- 2026-03-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- For Aim 1, in order to be eligible to participate in this study, a patient must meet all of the following criteria:
- Self-identifies as Black/African American
- Is ≥18 years old
- Was diagnosed with a stage III-IV solid tumor
- Is able to provide informed consent
- For Aims 2 and 3, in order to be eligible to participate in this study, a patient must meet all of the following criteria:
- Self-identifies as Black/African American
- Is ≥18 years old
- Was diagnosed with a stage III-IV solid tumor
- Is on active treatment (any line)
- Has an ECOG performance status of ≤2
- Has access to the internet
- Is able to provide informed consent
- For Aims 2 and 3, if a family-based intervention is selected as the program format, a patient must meet the additional following criterion:
- Has a family caregiver (e.g., spouse, adult child) with whom they currently reside
- Also, if a family-based intervention is selected as the program format, a caregiver must meet all of the following criteria:
- Is ≥18 years old
- Has access to the internet
- Is able to provide informed consent
You may not qualify if…
- For Aim 1, there are no exclusion criteria.
- For Aims 2 and 3, a patient who meets any of the following criteria will be excluded from participation in this study:
- Is pregnant
- Has cognitive deficits that would impede the completion of self-report instruments as deemed by the clinical team
- Participated in in the Aim 1 of this study
Where it is running
- M D Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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