CancerNCT05763797
Developing a Culturally Relevant Supportive Care Program for Black Patients Dealing With Advanced Cancer
A study testing Individual Interview and Meditation Exercise in people with Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Individual Interview and Meditation Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2023to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 19Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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.
- 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.
- Identify the feasibility of implementing the MBS-A and AC interventions as determined by session attendance, intervention acceptability, and treatment fidelity.
- Conditions
- Cancer
- Being tested
- Individual Interview, Meditation Exercise
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual InterviewBehavioural
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 ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Aim 1 (individual interview) | Experimental | Participants will be interviewed Receives: Behavioral: Individual Interview; Behavioral: Meditation Exercise |
| Aim 2 (supportive care program) | Experimental | Participants will be assigned to one of two groups Receives: Behavioral: Individual Interview; Behavioral: Meditation Exercise |
| Aim 3 (supportive care program) | Experimental | Participants will be assessed regarding their program participation Receives: Behavioral: Individual Interview; Behavioral: Meditation Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start13 Apr 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Dalnim Cho, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763797
- Sponsor's protocol ID
- 2022-1015
- Other IDs
- NCI-2023-01995
- Status last verified
- Sep 2026
- First submitted
- 28 Feb 2023
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Culturally Relevant Supportive Care Program for Black Patients Dealing With Advanced Cancer
- ClinicalTrials.gov ID
- NCT05763797
- Acronym / sponsor ID
- 2022-1015
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 170 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- Identify the feasibility of implementing the MBS-A and AC interventions as determined by session attendance, intervention acceptability, and treatment fidelity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aim 1 (individual interview) | Experimental | Behavioral: Individual Interview, Behavioral: Meditation ExerciseParticipants will be interviewed |
| Aim 2 (supportive care program) | Experimental | Behavioral: Individual Interview, Behavioral: Meditation ExerciseParticipants will be assigned to one of two groups |
| Aim 3 (supportive care program) | Experimental | Behavioral: Individual Interview, Behavioral: Meditation ExerciseParticipants will be assessed regarding their program participation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual InterviewGroup 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. | Behavioural | Aim 1 (individual interview), Aim 2 (supportive care program), Aim 3 (supportive care program) |
| Meditation ExerciseGroup 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. | Behavioural | Aim 1 (individual interview), Aim 2 (supportive care program), Aim 3 (supportive care program) |
Primary outcome
MD Anderson Symptom Inventory-Score Scale
Time frame: through study completion; an average of 1 year.
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."
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dalnim Cho, PhD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual Interview and Meditation Exercise in people with Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MD Anderson Symptom Inventory-Score Scale (time frame: through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.