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

Trial Summary

What is the purpose of this trial?

The goal of this pilot clinical trial is to test a disease-tailored, mindfulness-based intervention (Mindful Self-Compassion for Lung Cancer; MSC-LC) in adults diagnosed with lung cancer who are experiencing stigma. The current project seeks to: * Evaluate preliminary evidence for the feasibility, acceptability, and preliminary efficacy of MSC-LC in reducing stigma for adults with lung cancer, compared to a waitlist control condition * Elicit interventional impact not captured through quantitative measures with qualitative data from purposively sampled high responders and non-responders from the intervention condition Participants will randomized to either the MSC-LC intervention (a 10-week, virtually-delivered, group-based psychosocial intervention focused on the development of mindfulness and self-compassion skills) or to a waitlist control group that receives a referral to an NCI list of helpful mental health resources in their community. Researchers will compare the intervention and control groups to see if the MSC-LC intervention reduces lung cancer stigma and increases self-compassion.

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 data supports the effectiveness of the treatment Mindful Self-Compassion for Lung Cancer (MSC-LC)?

Research shows that mindfulness and self-compassion can help reduce psychological distress and improve communication in couples facing lung cancer. Additionally, mindfulness-based interventions have been found to reduce symptoms and promote positive psychological outcomes in cancer patients, suggesting potential benefits for those with lung cancer. ^{1 2 3 4 5}

Is Mindful Self-Compassion safe for people with lung cancer?

Mindful Self-Compassion and similar mindfulness practices have been studied in cancer patients and are generally considered safe, with no significant safety concerns reported in the research. These practices are often used to help improve emotional well-being and reduce stress. ^{1 4 6 7 8}

How is the Mindful Self-Compassion treatment unique for lung cancer patients?

Mindful Self-Compassion for Lung Cancer (MSC-LC) is unique because it focuses on enhancing mindfulness and self-compassion skills, which can help reduce psychological distress and improve communication in patients and their partners. Unlike traditional medical treatments, this approach emphasizes mental and emotional well-being, potentially benefiting both the individual and their relationships. ^{1 4 5 9 10}

Research Team

Timothy J Williamson, Ph.D., MPH

Principal Investigator

Loyola Marymount University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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 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]

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]

References

1. Scotland pubmed.ncbi.nlm.nih.gov

Quality of life, self-compassion and mindfulness in cancer patients undergoing chemotherapy: A cross-sectional study. [2021]

2. New Zealand pubmed.ncbi.nlm.nih.gov

The impact of mindfulness-based interventions on symptom burden, positive psychological outcomes, and biomarkers in cancer patients. [2020]

3. Scotland pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based therapy for patients with breast cancer: A systematic review and meta-analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Are Mindfulness and Self-Compassion Related to Psychological Distress and Communication in Couples Facing Lung Cancer? A Dyadic Approach. [2020]

5. Switzerland 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. [2022]

6. United States 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

Effects of Mindfulness-Based Therapy for Cancer Patients: A Systematic Review and Meta-analysis. [2022]

9. United States 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). [2021]

10. England pubmed.ncbi.nlm.nih.gov

Feasibility and potential benefits of partner-supported yoga on psychosocial and physical function among lung cancer patients. [2022]