~20 spots leftby Mar 2027

Culturally Relevant Supportive Care for Advanced Cancer

Recruiting in Palo Alto (17 mi)
DC
Overseen byDalnim Cho, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: M.D. Anderson Cancer Center
Disqualifiers: Pregnancy, Cognitive deficits, others
No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current treatment since the study involves a supportive care strategy and not a new drug.

What data supports the effectiveness of the treatment Meditation-Based Support-Adapted (MBS-A) for advanced cancer?

Research shows that mindfulness-based interventions, like the Meditation-Based Support-Adapted (MBS-A), can improve psychological well-being and reduce suffering in patients with advanced cancer. These treatments have been found to enhance quality of life and coping skills in cancer patients, suggesting they may be beneficial as supportive care.12345

Is the Meditation-Based Support-Adapted (MBS-A) treatment safe for humans?

Research on mindfulness-based interventions, including Meditation-Based Support-Adapted (MBS-A), suggests they are generally safe for humans, with benefits like reduced stress and improved sleep in cancer patients. No significant safety concerns have been reported in the studies reviewed.46789

How is the Meditation-Based Support-Adapted (MBS-A) treatment different from other treatments for advanced cancer?

The Meditation-Based Support-Adapted (MBS-A) treatment is unique because it focuses on mindfulness and cultural relevance, aiming to improve psychological well-being and reduce suffering in advanced cancer patients by helping them find meaning and manage stress. Unlike traditional treatments, it incorporates mindfulness practices and is adapted to be culturally relevant, particularly for minority groups, enhancing its effectiveness and acceptance.1351011

Research Team

DC

Dalnim Cho, PhD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for Black/African American individuals aged 18 or older with stage III-IV solid tumors, on active treatment, and have a performance status allowing daily activity. They must be able to consent and have internet access. If the program is family-based, they need a caregiver living with them who can also participate.

Inclusion Criteria

I am 18 or older, identify as Black/African American, and have a late-stage solid tumor.
I am Black/African American, 18+, with stage III-IV solid tumor, on treatment, can move around, have internet, and can consent.
I live with a family member who can care for me.
See 1 more

Exclusion Criteria

For Aims 2 and 3, patient will be excluded if pregnant, has cognitive deficits that impede completion of self-report instruments, or participated in Aim 1 of this study

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Formative Research

Conduct quantitative surveys and in-depth interviews to determine the intervention format for the MBS-A program

8 weeks
Multiple visits (in-person and virtual)

Pilot Randomized Controlled Trial (RCT)

Conduct a pilot RCT to examine the feasibility of the MBS-A intervention vs. a dose-matched attention control group

12 weeks
Weekly sessions (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

Treatment Details

Interventions

  • Meditation-Based Support-Adapted (MBS-A) (Behavioral Intervention)
Trial OverviewThe study tests a culturally adapted mind-body intervention called MBS-A designed for Black patients with advanced cancer. It involves surveys, interviews, meditation exercises, and possibly group sessions to see if it's feasible as supportive care compared to standard psychoeducation.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Aim 3 (supportive care program)Experimental Treatment2 Interventions
Participants will be assessed regarding their program participation
Group II: Aim 2 (supportive care program)Experimental Treatment2 Interventions
Participants will be assigned to one of two groups
Group III: Aim 1 (individual interview)Experimental Treatment2 Interventions
Participants will be interviewed

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3107
Patients Recruited
1,813,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials
886
Patients Recruited
677,000+

Findings from Research

The acceptability and potential benefits of mindfulness-based interventions in improving psychological well-being for adults with advanced cancer: A systematic review.Zimmermann, FF., Burrell, B., Jordan, J.[2018]
The effects of mindfulness-based stress reduction on psychosocial outcomes and quality of life in early-stage breast cancer patients: a randomized trial.Henderson, VP., Clemow, L., Massion, AO., et al.[2022]
Mindfulness-based supportive therapy on reducing suffering in patients with advanced cancer: randomised controlled trial.Tan, SB., Chee, CH., Ngai, CF., et al.[2022]
Measuring the psychological impact of mindfulness meditation on health among patients with cancer: a literature review.Matchim, Y., Armer, JM.[2007]
Mindfulness-based stress reduction: what processes are at work?Dobkin, PL.[2022]
Impact of mindfulness-based stress reduction (MBSR) on sleep, mood, stress and fatigue symptoms in cancer outpatients.Carlson, LE., Garland, SN.[2018]
The impact of mindfulness-based interventions on symptom burden, positive psychological outcomes, and biomarkers in cancer patients.Rouleau, CR., Garland, SN., Carlson, LE.[2020]
The effects of mindfulness-based interventions on symptoms of depression, anxiety, and cancer-related fatigue in oncology patients: A systematic review and meta-analysis.Chayadi, E., Baes, N., Kiropoulos, L.[2022]
Association of Mindfulness-Based Interventions With Anxiety Severity in Adults With Cancer: A Systematic Review and Meta-analysis.Oberoi, S., Yang, J., Woodgate, RL., et al.[2020]
Cognitive-behavioral and mindfulness-based interventions for distress in patients with advanced cancer: A meta-analysis.Krueger, E., Secinti, E., Stewart, JC., et al.[2023]
Psychosocial Intervention Cultural Adaptation for Latinx Patients and Caregivers Coping with Advanced Cancer.Torres-Blasco, N., Costas-Muñiz, R., Rosario, L., et al.[2022]

References

The acceptability and potential benefits of mindfulness-based interventions in improving psychological well-being for adults with advanced cancer: A systematic review. [2018]
The effects of mindfulness-based stress reduction on psychosocial outcomes and quality of life in early-stage breast cancer patients: a randomized trial. [2022]
Mindfulness-based supportive therapy on reducing suffering in patients with advanced cancer: randomised controlled trial. [2022]
Measuring the psychological impact of mindfulness meditation on health among patients with cancer: a literature review. [2007]
Mindfulness-based stress reduction: what processes are at work? [2022]
Impact of mindfulness-based stress reduction (MBSR) on sleep, mood, stress and fatigue symptoms in cancer outpatients. [2018]
The impact of mindfulness-based interventions on symptom burden, positive psychological outcomes, and biomarkers in cancer patients. [2020]
The effects of mindfulness-based interventions on symptoms of depression, anxiety, and cancer-related fatigue in oncology patients: A systematic review and meta-analysis. [2022]
Association of Mindfulness-Based Interventions With Anxiety Severity in Adults With Cancer: A Systematic Review and Meta-analysis. [2020]
Cognitive-behavioral and mindfulness-based interventions for distress in patients with advanced cancer: A meta-analysis. [2023]
Psychosocial Intervention Cultural Adaptation for Latinx Patients and Caregivers Coping with Advanced Cancer. [2022]