Developing a Culturally Relevant Supportive Care Program for Black Patients Dealing With Advanced Cancer
NCT ID: NCT05763797
Last Updated: 2025-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-04-13
2029-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Aim 1 (individual interview)
Participants will be interviewed
Individual Interview
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.
Meditation Exercise
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.
Aim 2 (supportive care program)
Participants will be assigned to one of two groups
Individual Interview
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.
Meditation Exercise
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.
Aim 3 (supportive care program)
Participants will be assessed regarding their program participation
Individual Interview
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.
Meditation Exercise
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.
Interventions
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Individual Interview
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.
Meditation Exercise
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
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Inclusion 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
* 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
18 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Dalnim Cho, PhD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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M D Anderson Cancer Center
Other Identifiers
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NCI-2023-01995
Identifier Type: OTHER
Identifier Source: secondary_id
2022-1015
Identifier Type: -
Identifier Source: org_study_id
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