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Active Not Recruiting
NCT05763797
Developing a Culturally Relevant Supportive Care Program for Black Patients Dealing With Advanced Cancer
Conditions: Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 170
Sponsor: M.D. Anderson Cancer Center
Location: M D Anderson Cancer Center Houston Texas
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.
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Source: ClinicalTrials.gov (NCT05763797). StuddyBuddy aggregates publicly available trial information.