Mindfulness Relaxation for Cancer Caregivers

Overseen By Larkin Strong

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Under 18, No internet, others

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

Compensation: Varies

Number of Visits: 3

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop mindfulness programs to support Latino cancer patients and their caregivers, focusing on improving mental well-being and reducing cancer-related stress and anxiety. Participants will join mindfulness relaxation sessions either alone or with a family member, meeting with a coach weekly for four weeks. Those with stage III or IV solid tumors, currently undergoing treatment, and living with a family caregiver who will join them can consider participating. As an unphased trial, this study offers a unique opportunity to enhance mental well-being and reduce stress through mindfulness practices.

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 is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this mindfulness-based intervention is safe?

Research shows that mindfulness-based programs are generally safe and manageable. These programs increase awareness of thoughts, feelings, and body sensations, which can reduce stress and anxiety. Studies have found that these programs significantly reduce fatigue in cancer patients. They may also help lower stress, anxiety, and depression, and improve sleep issues.

Overall, there are no major reports of negative side effects from participating in these mindfulness programs. This makes them a safe choice for those seeking to enhance mental well-being during challenging times, such as dealing with cancer or supporting a loved one with the illness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mindfulness relaxation program for cancer caregivers because it offers a unique way to support mental health by focusing on building awareness of thoughts, emotions, feelings, and sensations. Unlike traditional treatments such as medication or therapy, this program involves a mindfulness coach guiding participants in either individual or joint sessions with their partners. This approach not only provides a personalized experience but also enhances the coping strategies of caregivers, potentially improving their overall well-being and resilience during challenging times.

What evidence suggests that mindfulness relaxation is effective for improving mental well-being in cancer caregivers?

Research has shown that mindfulness relaxation can greatly benefit cancer patients and their caregivers. In this trial, participants will join different mindfulness program groups. Studies have found that those who participate in mindfulness programs often experience reduced depression, anxiety, and stress. Caregivers also report feeling less stressed and anxious, which improves their overall well-being. For cancer patients, mindfulness can enhance mental health, increase support from friends and family, and strengthen their sense of purpose. Overall, these programs offer a promising way to improve mental health and quality of life for both patients and their families. ^{6 7 8 9 10}

Who Is on the Research Team?

Larkin Strong

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for Latino adults with stage III-IV solid tumors who are on active treatment and have an ECOG performance status of <=2. Participants must be willing to join the study with a family caregiver they live with, who also consents. Both must self-identify as Hispanic/Latino, be at least 18 years old, speak English or Spanish, and have internet access.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.

I am currently receiving treatment for my condition.

You identify yourself as a Hispanic or Latino person.

Exclusion Criteria

I can speak English or Spanish.

Able to provide informed consent

You can go online and have an internet connection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Mindfulness Program

Participants engage in a mindfulness program with a coach to build awareness of thoughts, emotions, feelings, and sensations

4 weeks

1 visit per week (in-person or virtual)

Follow-up

Participants are monitored for psychological distress, quality of life, and cancer symptoms

8 weeks

2 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness Relaxation

Trial Overview

The trial is testing mindfulness-based interventions designed for Latino cancer patients and their caregivers. It includes mindfulness relaxation techniques, filling out questionnaires, and assessing quality of life to see if these methods can improve mental well-being and reduce stress related to cancer.

How Is the Trial Designed?

Group I: Group II (mindfulness program) Experimental Treatment 4 Interventions

Patients and their partners participate separately in mindfulness program over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations QW for 4 weeks.

Group II: Group I (mindfulness program) Experimental Treatment 4 Interventions

Patients and their partners participate together in mindfulness program over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations QW for 4 weeks.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

The mindfulness-based cancer recovery (MBCR) program significantly improved psychological well-being and quality of life in 101 cancer patients after an 8-week intervention, with benefits including reduced stress and depression, and increased optimism and vitality.

These positive effects were sustained for at least 6 months after the intervention, indicating that MBCR is an effective long-term psychosocial treatment for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of mindfulness-based cancer recovery (MBCR) program among Hungarian cancer patients]. Rohánszky, M., Berényi, K., Fridrik, D., et al.[2017]

Mindfulness-based interventions (MBIs) show potential to improve overall well-being and reduce the burden on family caregivers of cancer patients, although evidence is limited.

Educational interventions (EIs) also demonstrate positive effects on certain aspects of well-being and burden reduction for family caregivers, suggesting both MBIs and EIs can be beneficial supportive care options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The implementation of mindfulness-based interventions and educational interventions to support family caregivers of patients with cancer: A systematic review. Al Daken, LI., Ahmad, MM.[2018]

Mindfulness-based stress reduction (MBSR) may help improve sleep quality and duration, as suggested by four uncontrolled studies, but controlled studies have not consistently shown significant benefits.

There is evidence that practicing mindfulness techniques can reduce cognitive processes like worry that interfere with sleep, indicating a potential mechanism for how MBSR might improve sleep, though more rigorous research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of mindfulness-based stress reduction on sleep disturbance: a systematic review. Winbush, NY., Gross, CR., Kreitzer, MJ.[2022]

A pilot study involving 21 caregivers of cancer patients undergoing stem cell transplants showed that a 6-week mindfulness-based intervention (FOCUS) was highly feasible and acceptable, with 71% attending at least four sessions and all participants reporting skill usage at follow-up.

Participants experienced significant improvements in mindfulness, post-traumatic growth, and general mental health, along with reductions in negative emotions, indicating that FOCUS effectively supports caregivers' mental well-being during a stressful period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mindfulness-based intervention for caregivers of allogeneic hematopoietic stem cell transplant patients: Pilot results. Vinci, C., Pidala, J., Lau, P., et al.[2020]

This study is a 3-arm randomized controlled trial examining the efficacy of a 6-week mindfulness-based program (FOCUS) aimed at reducing caregiver burden among caregivers of allogeneic hematopoietic stem cell transplant patients, with ongoing recruitment for participants.

The trial will assess caregiver burden and patient health outcomes, using daily diaries and hair cortisol concentrations as biomarkers to measure stress levels, providing valuable data on the impact of mindfulness on both caregivers and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mindfulness-based stress management program for caregivers of allogeneic hematopoietic stem cell transplant (HCT) patients: Protocol for a randomized controlled trial. Yang, MJ., Yepez, VV., Brandon, KO., et al.[2022]

Mindfulness-based music therapy (MBMT) has shown significant benefits in improving attention and reducing negative mood and fatigue in women undergoing adjuvant chemotherapy for breast cancer, as indicated by a pilot study.

The study highlights the potential of integrating music therapy with mindfulness practices to enhance the overall well-being of breast cancer patients, suggesting further exploration of music's role in mindfulness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development of a Mindfulness-Based Music Therapy (MBMT) Program for Women Receiving Adjuvant Chemotherapy for Breast Cancer. Lesiuk, T.[2020]

Both group face-to-face mindfulness-based cognitive therapy (MBCT) and individual internet-based mindfulness-based cognitive therapy (eMBCT) led to long-term reductions in psychological distress and increases in mental health-related quality of life over a nine-month follow-up period for 245 distressed cancer patients.

Patients who participated in eMBCT reported lower psychological distress compared to those in MBCT, particularly benefiting those with lower baseline mindfulness and conscientiousness, suggesting that eMBCT may be a more effective option for certain individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consolidation and prediction of long-term treatment effect of group and online mindfulness-based cognitive therapy for distressed cancer patients. Cillessen, L., Schellekens, MPJ., Van de Ven, MOM., et al.[2019]

An 8-week mindfulness-based stress reduction (MBSR) program significantly improved mood and reduced stress symptoms for both cancer patients and their partners, with notable reductions in muscle tension and other stress-related symptoms.

Both patients and partners reported increased mindfulness after participating in the program, suggesting that MBSR can enhance psychological well-being for couples dealing with cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological benefits for cancer patients and their partners participating in mindfulness-based stress reduction (MBSR). Birnie, K., Garland, SN., Carlson, LE.[2010]

Mindfulness-based interventions (MBI) significantly improved sleep quality in cancer patients, with a moderate effect size (SMD = 0.37) based on a meta-analysis of 14 studies involving 1659 participants.

While MBI showed potential in reducing benzodiazepine (BZDs) use, the evidence was limited, with only three studies reporting this outcome, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of mindfulness-based intervention on sleep disturbance and benzodiazepine hypnotics use in patients hospitalized with cancer: A systematic review and meta-analysis. Yang, B., Nie, Q., Yang, Y.[2021]

Mindfulness-based cognitive therapy (MBCT) is an effective intervention designed to help caregivers of cancer survivors manage their mental health by changing their relationship with their thoughts, rather than trying to change the thoughts themselves.

The manuscript provides a detailed session-by-session guide on how to adapt MBCT specifically for caregivers, aiming to reduce their burden and improve their overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindful caring: using mindfulness-based cognitive therapy with caregivers of cancer survivors. Wood, AW., Gonzalez, J., Barden, SM.[2018]

The Being Present audio-based mindfulness meditation program, tested over 8 weeks with 53 participants (33 patients and 20 caregivers), showed significant reductions in distress and anxiety levels among patients with metastatic colorectal cancer and their caregivers.

Participants reported high adherence to the program, with 59% practicing mindfulness regularly, and 79% expressed intentions to continue practicing after the study, indicating the program's feasibility and acceptability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Being Present: A single-arm feasibility study of audio-based mindfulness meditation for colorectal cancer patients and caregivers. Atreya, CE., Kubo, A., Borno, HT., et al.[2023]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8200136/

Mindfulness-Based Interventions in Cancer Survivors

There were significant improvements in depression (d= 0.83), anxiety (d= 0.59), and stress (d=0.53) scores for MBCT participants compared with ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S0272735824001260

Positive health outcomes of mindfulness-based ...

Among cancer patients, these interventions have demonstrated improvements in mindfulness, social support, well-being, meaningfulness, and spirituality (Carlson ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11234071/

Effectiveness of Web-Based Mindfulness ...

App- and website-based MBIs show promise for improving mental health and QOL outcomes in patients with cancer, and further research is needed.

4.

bmcpalliatcare.biomedcentral.com

bmcpalliatcare.biomedcentral.com/articles/10.1186/s12904-024-01564-7

Mindfulness to enhance quality of life and support advance ...

A mindfulness-based intervention showed promise in improving quality-of-life and advance care planning outcomes in patients and caregivers ...

5.

sigmapubs.onlinelibrary.wiley.com

sigmapubs.onlinelibrary.wiley.com/doi/full/10.1111/wvn.12736

The effect of mindfulness‐based interventions on caregiver ...

This meta-analysis found MBIs to have positive effects on specific outcomes, such as stress, anxiety, depression, and caregiver burden. These ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8083197/

Mindfulness-based interventions: an overall review - PMC

A systematic review and meta-analysis found that MBIs led to a statistically significant reduction in cancer-related fatigue (CRF) score among ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04870788

Mindfulness-Based Intervention for Latino Cancer Patients ...

Mindfulness-based interventions focus on building awareness of thoughts, emotions/feelings, and the sensations. This study may help improve mental well-being ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8842457/

Being Present 2.0: Online Mindfulness-Based Program for ...

A metastatic cancer diagnosis is associated with high levels of distress in patients and caregivers, which may be alleviated by mindfulness interventions.

9.

nature.com

nature.com/articles/s44220-023-00081-5

Systematic review and individual participant data meta- ...

Mindfulness-based programs (MBPs) are widely used to prevent mental ill health. Evidence suggests beneficial average effects but wide variability.

10.

jmir.org

jmir.org/2020/11/e20709/

Mindfulness-Based Programs for Patients With Cancer via ...

In general, the results indicate that eMBPs have the potential to reduce the levels of stress, anxiety, depression, fatigue, sleep problems, and ...