Culturally Relevant Supportive Care for Advanced Cancer

Overseen By Dalnim Cho, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Cognitive deficits, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to support Black patients with advanced cancer by adapting a meditation program to better fit their cultural needs. Researchers aim to determine if this adjusted meditation support, called Meditation-Based Support-Adapted (MBS-A), can be effectively implemented and if it benefits patients compared to a standard information program. Suitable participants include Black patients currently undergoing treatment for stage III-IV solid tumors who have internet access. As an unphased trial, this study provides a unique opportunity for patients to contribute to culturally tailored cancer support research.

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 prior data suggests that this mind-body intervention is safe for Black advanced cancer patients?

Research shows that mindfulness activities, such as Meditation-Based Support-Adapted (MBS-A), are generally manageable for cancer patients. Studies indicate that these activities can help reduce anxiety, stress, and depression. Serious side effects rarely occur, making them a safe choice for many.

A review of studies found that most patients did not experience negative effects from mindfulness practices. Another study noted benefits like improved sleep and reduced stress. These findings suggest that mindfulness activities are safe for cancer patients, although individual experiences can vary. Patients should consult their healthcare provider to determine if this approach is suitable for them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Meditation-Based Support-Adapted (MBS-A) program because it offers a culturally tailored approach to supportive care for advanced cancer patients, which is largely absent in standard treatment options like chemotherapy, radiation, and surgery. Unlike conventional treatments that primarily focus on physical symptoms, MBS-A aims to address emotional and psychological needs through meditation, which can help improve overall well-being. This innovative approach may provide a holistic complement to existing therapies, potentially enhancing quality of life for patients by reducing stress and anxiety.

What evidence suggests that the Meditation-Based Support-Adapted (MBS-A) intervention could be effective for advanced cancer patients?

Research shows that mindfulness-based activities can help cancer patients. Studies indicate these activities reduce mood issues like anxiety and depression and improve quality of life. Reviews have found they also ease pain and stress, common among cancer patients. Evidence suggests they boost overall mental health and well-being. In this trial, participants will engage in mindfulness practices, such as the Meditation-Based Support-Adapted (MBS-A), which appear promising in addressing the emotional and psychological needs of cancer patients. ^{1 3 6 7 8}

Who Is on the Research Team?

Dalnim Cho, PhD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 live with a family member who can care for me.

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.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Meditation-Based Support-Adapted (MBS-A)

Trial Overview

The 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.

How Is the Trial Designed?

Group I: Aim 3 (supportive care program) Experimental Treatment 2 Interventions

Participants will be assessed regarding their program participation

Group II: Aim 2 (supportive care program) Experimental Treatment 2 Interventions

Participants will be assigned to one of two groups

Group III: Aim 1 (individual interview) Experimental Treatment 2 Interventions

Participants will be interviewed

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

Mindfulness-based interventions (MBIs) significantly reduce short-term anxiety in cancer patients, with a standardized mean difference of -0.51 based on 23 trials involving 2339 participants.

MBIs also lead to reductions in short-term and medium-term depression and improve health-related quality of life, but no significant long-term anxiety reduction was observed after 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A meta-analysis of 37 randomized controlled trials found that both traditional cognitive-behavioral interventions (CBIs) and mindfulness-based interventions (MBIs) resulted in small reductions in distress (effect size of 0.21) and minimal improvements in quality of life (effect size of 0.15) for patients with advanced cancer.

There was no significant difference in effectiveness between CBIs and MBIs, and interventions delivered to individuals had a greater positive impact on quality of life compared to those delivered in groups or dyads.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Mindfulness-based interventions (MBIs) have been shown to significantly reduce psychological distress, sleep disturbances, and fatigue in cancer patients, while also promoting personal growth in quality of life and spirituality.

There is emerging evidence that MBIs may positively influence biological markers related to immune function and stress regulation, although it is still uncertain if these changes lead to meaningful health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of mindfulness-based interventions on symptom burden, positive psychological outcomes, and biomarkers in cancer patients. Rouleau, CR., Garland, SN., Carlson, LE.[2020]

Mindfulness-based interventions (MBIs) have been found to be acceptable and beneficial for individuals with advanced cancer, improving their quality of life and reducing symptoms of depression and anxiety, based on a systematic review of 8 studies.

The review suggests that adapting MBIs to be more individualized and flexible, such as offering home-based options and shorter sessions, could enhance participation and effectiveness for critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study involving 172 women with early-stage breast cancer, an 8-week mindfulness-based stress-reduction (MBSR) program significantly improved quality of life and coping strategies compared to a nutrition education program and usual supportive care.

The benefits of MBSR included reductions in depression, anxiety, and emotional distress, although these improvements tended to decline over time, suggesting that MBSR could be a valuable complementary therapy in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

An 8-week Mindfulness-Based Stress Reduction (MBSR) program significantly improved sleep quality in 63 cancer patients, with overall sleep disturbance reduced (p < .001).

Participants also experienced significant reductions in stress, mood disturbance, and fatigue, suggesting that MBSR can enhance the overall quality of life for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of mindfulness-based stress reduction (MBSR) on sleep, mood, stress and fatigue symptoms in cancer outpatients. Carlson, LE., Garland, SN.[2018]

Mindfulness-based interventions (MBIs) significantly reduce symptoms of depression, anxiety, and cancer-related fatigue (CRF) in cancer patients, with medium effect sizes maintained for at least three months after the intervention.

In a review of 36 studies involving 1,677 participants, MBIs were found to be more effective than control groups in alleviating anxiety and CRF symptoms, highlighting their potential as a valuable component of oncological treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Mindfulness-based supportive therapy (MBST) significantly reduced suffering in patients with advanced cancer, as evidenced by a lower overall suffering score compared to a control group in a study of 73 patients.

Patients receiving MBST also showed significant improvements in anxiety, depression, and spiritual well-being, indicating that this therapy can enhance psychosocial outcomes in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based supportive therapy on reducing suffering in patients with advanced cancer: randomised controlled trial. Tan, SB., Chee, CH., Ngai, CF., et al.[2022]

A qualitative study involving 14 Latinx advanced cancer patients and 14 caregivers showed that 85.7% reported high acceptance of the CASA psychosocial intervention, indicating its relevance and potential effectiveness for this community.

Participants expressed a strong willingness to engage with the intervention's components, such as communication skills and finding meaning in life, and most supported the inclusion of family caregivers in therapy sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial Intervention Cultural Adaptation for Latinx Patients and Caregivers Coping with Advanced Cancer. Torres-Blasco, N., Costas-Muñiz, R., Rosario, L., et al.[2022]

Mindfulness-based stress reduction (MBSR) shows promising psychological benefits for cancer patients, as indicated by various instruments measuring its impact, although the effectiveness of these instruments varies.

The review highlights the need for more rigorous intervention studies on MBSR in cancer care to better understand its benefits and to refine the tools used to measure its effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring the psychological impact of mindfulness meditation on health among patients with cancer: a literature review. Matchim, Y., Armer, JM.[2007]

Women who completed an 8-week Mindfulness-Based Stress Reduction (MBSR) program after breast cancer treatment reported significant improvements in mindfulness and self-care coping strategies, as measured by specific questionnaires.

Participants also experienced a greater sense of meaning and manageability in life, supporting the idea that MBSR helps individuals 'reperceive' their daily experiences positively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction: what processes are at work? Dobkin, PL.[2022]

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