Developing a Culturally Relevant Supportive Care Program for Black Patients Dealing With Advanced Cancer
2 other identifiers
interventional
170
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cancer
Started Apr 2023
Longer than P75 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2023
CompletedFirst Posted
Study publicly available on registry
March 10, 2023
CompletedStudy Start
First participant enrolled
April 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2029
March 11, 2026
March 1, 2026
4 years
February 28, 2023
March 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
MD Anderson Symptom Inventory-Score Scale
MD Anderson Symptom Inventory, which consists of 13 core items assessing symptom severity and 6 items assessing symptom interference with daily living.71,72 If the family-based format is selected, patients and caregivers will complete the form as it applies to their own symptoms as well as their perceptions of each other's symptoms.73 MD Anderson Symptom Inventory-Score Scale "at its worst" using 0-10 numerical rating scales with 0 = "not present" and 10 = "as bad as you can imagine."
through study completion; an average of 1 year.
Study Arms (3)
Aim 1 (individual interview)
EXPERIMENTALParticipants will be interviewed
Aim 2 (supportive care program)
EXPERIMENTALParticipants will be assigned to one of two groups
Aim 3 (supportive care program)
EXPERIMENTALParticipants will be assessed regarding their program participation
Interventions
Group 1, participant will be in a supportive care program with other Black cancer patients in which you will practice meditation. Group 2, participate will be in a supportive care program with other Black cancer patients that focuses on coping with cancer. Participants will be asked to participate weekly sessions for 4 weeks (that is a total of 4 sessions) and each session will last about 60 minutes. Both groups will be delivered via Zoom (a web-based videoconferencing service) and led by a master's-level interventionist.
Group 1, participant will be in a supportive care program with other Black cancer patients in which you will practice meditation. Group 2, participate will be in a supportive care program with other Black cancer patients that focuses on coping with cancer. Participants will be asked to participate weekly sessions for 4 weeks (that is a total of 4 sessions) and each session will last about 60 minutes. Both groups will be delivered via Zoom (a web-based videoconferencing service) and led by a master's-level interventionist.
Eligibility Criteria
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
- +4 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Dalnim Cho, PhD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2023
First Posted
March 10, 2023
Study Start
April 13, 2023
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2029
Last Updated
March 11, 2026
Record last verified: 2026-03