Mindful Self-Compassion for Lung Cancer

Overseen By Timothy J Williamson, Ph.D., MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Loyola Marymount University

Must not be taking: Antidepressants, Anxiolytics, Antipsychotics, Mood stabilizers

Disqualifiers: Personality dysfunction, Recent meditation training, others

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

Compensation: Varies

Number of Visits: 5

Duration: 10 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a mindfulness-based program can assist people with lung cancer who feel stigmatized. The program, Mindful Self-Compassion for Lung Cancer (MSC-LC), teaches mindfulness and self-compassion skills over 10 weeks. Researchers aim to determine if this program reduces stigma and enhances self-compassion compared to a waitlist group. Adults diagnosed with lung cancer who experience stigma and haven't recently completed a similar program or changed medications might be suitable for this trial. Participants will either join the program or receive mental health resources and participate later.

As an unphased trial, this study provides a unique opportunity to explore new methods for improving emotional well-being in those stigmatized by lung cancer.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on antidepressant, anxiolytic, antipsychotic, or mood stabilizing medications, your dose should not have been changed in the 8 weeks before joining the study.

What prior data suggests that this mindfulness-based intervention is safe for adults with lung cancer?

Research has shown that mindful self-compassion (MSC) is safe and well-tolerated by patients. Studies have found that MSC helps people be kinder to themselves and reduces feelings of shame and distress. Participants in these studies did not report any serious side effects or harm. Instead, they experienced small-to-medium improvements in symptoms of depression, stress, and loneliness.

The Mindful Self-Compassion for Lung Cancer (MSC-LC) program tailors these techniques specifically for people with lung cancer. It focuses on helping them develop mindfulness and self-compassion skills. The goal is to reduce the stigma and stress often associated with a lung cancer diagnosis. This approach is gentle and supportive, making it a safe choice for many. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Mindful Self-Compassion for Lung Cancer (MSC-LC) because it offers a fresh approach to addressing the emotional and psychological challenges faced by patients. Unlike traditional treatments that focus on the physical aspects of lung cancer, MSC-LC is a group-based intervention that enhances mindfulness and self-compassion, aiming to reduce the stigma associated with the condition. This innovative method could provide an important complementary strategy alongside standard medical care, potentially improving the overall well-being and quality of life for patients.

What evidence suggests that Mindful Self-Compassion for Lung Cancer is effective in reducing stigma?

Research has shown that Mindful Self-Compassion (MSC) effectively increases self-kindness and reduces feelings of shame and distress in people with lung cancer. Early studies found that MSC helps individuals feel better about themselves and manage tough emotions. In this trial, participants in the Mindful Self-Compassion for Lung Cancer (MSC-LC) arm will engage in a program specifically designed to reduce stigma, the negative feeling associated with having lung cancer. By teaching mindfulness and self-compassion skills, this program aids in managing emotions and improving emotional well-being. Initial feedback from participants in similar programs indicates they feel less stigmatized and more compassionate toward themselves. ^{1 2 3 4 6}

Who Is on the Research Team?

Timothy J Williamson, Ph.D., MPH

Principal Investigator

Loyola Marymount University

Are You a Good Fit for This Trial?

This trial is for adults with lung cancer who feel stigmatized because of their diagnosis. Participants will be randomly assigned to either learn mindfulness and self-compassion skills in a virtual group setting over 10 weeks or placed on a waitlist while receiving standard mental health resources.

Inclusion Criteria

I have been diagnosed with lung cancer, confirmed by my doctor.

Able to read and respond to questions in English

Endorses elevated levels of lung cancer stigma (scores >37.5 on the Lung Cancer Stigma Inventory)

Exclusion Criteria

I haven't started or changed any mental health meds in the last 8 weeks.

I understand the study procedures and consent process and do not have significant personality issues that would interfere with participation.

I have completed a mindfulness or meditation course in the past year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Mindful Self-Compassion for Lung Cancer (MSC-LC) intervention, a 10-week, virtually-delivered, group-based psychosocial intervention focused on mindfulness and self-compassion skills

10 weeks

Weekly virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Assessments at 5 weeks and 16 weeks post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Mindful Self-Compassion for Lung Cancer (MSC-LC)

Trial Overview

Researchers are testing a new program called Mindful Self-Compassion for Lung Cancer (MSC-LC) against an enhanced standard of care. They want to see if MSC-LC can help reduce feelings of stigma and increase self-kindness among lung cancer patients.

How Is the Trial Designed?

Group I: Mindful Self-Compassion for Lung Cancer (MSC-LC) Experimental Treatment 1 Intervention

Group-based psychosocial intervention adapted from Mindful Self-Compassion that focuses on the development of mindfulness and self-compassion skills to reduce lung cancer stigma.

Group II: Enhanced standard of care with waitlist Active Control 1 Intervention

Control group that will receive a list of mental health resources and will complete questionnaire assessments during a parallel timeframe as participants in the intervention condition and be placed on a waiting list to receive the MSC-LC intervention after study completion.

Who Is Running the Clinical Trial?

Loyola Marymount University

Lead Sponsor

Trials

9

Recruited

8,800+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 88 couples facing lung cancer, both patients and their spouses showed that higher levels of self-compassion were significantly associated with lower psychological distress, indicating that self-compassion may be a key factor in coping with cancer-related stress.

The study suggests that mindfulness and self-compassion not only benefit individuals but may also enhance communication within couples, highlighting the potential for mindfulness-based interventions to improve couple dynamics during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are Mindfulness and Self-Compassion Related to Psychological Distress and Communication in Couples Facing Lung Cancer? A Dyadic Approach. Schellekens, MPJ., Karremans, JC., van der Drift, MA., et al.[2020]

In a study involving 979 participants from an online health community, those who engaged in Loving Kindness Meditation (LKM) immediately reported significant improvements in perceived stress, self-compassion, and social connectedness compared to those who started the practice after a 3-week delay.

The effectiveness of LKM increased with more frequent practice, suggesting that regular engagement in this mind-body approach can enhance emotional resilience during challenging health journeys.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Trial of 21 Days of Loving Kindness Meditation for Stress Reduction and Emotional Well-being Within an Online Health Community for Patients, Family, and Friends Experiencing a Cancer Health Journey. Telke, S., Leininger, B., Hanson, L., et al.[2022]

Mindfulness-based therapy (MBT) significantly reduces anxiety, depression, fear of recurrence, and fatigue in breast cancer patients, based on a meta-analysis of seven studies involving 951 participants.

MBT also improves emotional well-being, physical function, and physical health in these patients, suggesting it could be a valuable complementary treatment alongside standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based therapy for patients with breast cancer: A systematic review and meta-analysis. Zhang, J., Xu, R., Wang, B., et al.[2022]

The pilot study of the 'Breathe Easier' mindfulness-based intervention showed strong feasibility among 62 participants, with 79% completing the 8-week program, indicating that such interventions can be effectively implemented for lung cancer survivors and their families.

Participants who engaged in level 1 yoga reported significant improvements in dyspnea, fatigue, sleep quality, and stress, while level 2 participants showed mixed results, highlighting the need for tailored approaches in mindfulness interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective Pilot Study Evaluating Feasibility and Preliminary Effects of Breathe Easier: A Mindfulness-based Intervention for Survivors of Lung Cancer and Their Family Members (Dyads). McDonnell, KK., Gallerani, DG., Newsome, BR., et al.[2021]

A 12-week pilot trial involving 46 patients with lung cancer showed that a low-moderate intensity yoga program significantly improved psychosocial outcomes like fatigue, depression, and sleep disturbance in 54% of participants, along with quality of life improvements in 77%.

The study also found that physical functions such as flexibility and strength improved in a high percentage of participants, with no serious adverse events reported, suggesting that partner-supported yoga could be a safe and beneficial complementary therapy during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and potential benefits of partner-supported yoga on psychosocial and physical function among lung cancer patients. Sullivan, DR., Medysky, ME., Tyzik, AL., et al.[2022]

Mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT) significantly improve quality of life in cancer patients, with a strong effect size of 0.80 based on a meta-analysis of 18 randomized controlled trials.

These interventions are particularly effective in early-stage cancer patients, showing significant reductions in anxiety, pain, and fatigue, especially among younger participants, within a short-term period after the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Mindfulness-Based Therapy for Cancer Patients: A Systematic Review and Meta-analysis. Lin, LY., Lin, LH., Tzeng, GL., et al.[2022]

In a study of 183 chemotherapy patients, higher levels of self-compassion and mindfulness were significantly associated with better quality of life, indicating that these psychological traits may play a beneficial role during cancer treatment.

The research suggests that self-compassion and mindfulness could be important factors to explore in future studies aimed at improving the quality of life for cancer patients, potentially leading to interventions that enhance these traits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life, self-compassion and mindfulness in cancer patients undergoing chemotherapy: A cross-sectional study. Garcia, ACM., Camargos Junior, JB., Sarto, KK., et al.[2021]

The mindfulness-based stress reduction (MBSR) program significantly reduced cancer-related fatigue and negative psychological states in lung cancer patients, based on a meta-analysis of 17 studies involving 1,680 patients.

MBSR also improved positive psychological states and quality of sleep, suggesting it could be an effective part of rehabilitation for lung cancer patients, although its overall impact on quality of life showed only a trend toward significance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Mindfulness-Based Stress Reduction (MBSR) on Psychological Outcomes and Quality of Life in Patients With Lung Cancer: A Meta-Analysis. Tian, X., Yi, LJ., Liang, CS., et al.[2022]

A one-day Macmillan course on mindful compassion had lasting positive effects on emotional wellbeing, with 56% of participants using the techniques to improve their home and work life, relationships, and family dynamics.

Two to three years after the course, many participants continued to practice mindful compassion, reporting benefits such as reduced anxiety, improved sleep, better pain management, and enhanced focus, indicating the long-term efficacy of the training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of mindful compassion for staff, patients and carers. Lowson, P.[2022]

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]

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