ClinicalTrials.gg
CompletedNCT06191939MSC-LCUpdated Apr 13, 2026

Adapting and Testing a Novel Self-Compassion Intervention to Reduce Lung Cancer Stigma

An interventional study of Mindful Self-Compassion for Lung Cancer (MSC-LC) and Enhanced standard of care with waitlist in Lung Cancer, sponsored by Loyola Marymount University. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by Loyola Marymount University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
79
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study summary

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.

Read the detailed description

Lung cancer stigma (i.e., perceived and internalized negative appraisal and devaluation associated with lung cancer) is a pervasive problem experienced by the majority of lung cancer patients. Notably, experiences of lung cancer stigma are strongly associated with poorer quality of life and higher depressive symptoms. Despite these associations, there is a gap in the field regarding empirically supported, patient-focused interventions that target the reduction of lung cancer stigma.

Self-compassion (i.e., directed kindness towards oneself in times of suffering) is a protective psychosocial factor that has been targeted through intervention approaches to reduce shame and self-criticism in non-cancer samples. Additionally, higher self-compassion has been shown to attenuate the relationship between lung cancer stigma and depression, suggesting that fostering self-compassion may be an effective intervention strategy to reduce lung cancer stigma. Mindful Self-Compassion is an empirically supported, 8-week psychosocial intervention demonstrated to increase self-compassion and reduce feelings of shame, distress, depression, and anxiety in non-cancer samples. However, given several anticipated challenges associated with delivering Mindful Self-Compassion to lung cancer patients (e.g., breathing challenges that arise during breath-focused meditations, fatigue that interferes with attending 3-hour sessions), the investigators developed an adapted version of the intervention (Mindful Self-Compassion for Lung Cancer; MSC-LC) that is tailored to the needs of adults diagnosed with lung cancer, addresses delivery challenges, and targets the reduction of lung cancer stigma.

This is a pilot trial examining the feasibility, acceptability, and preliminary efficacy of MSC-LC, compared to waitlist control condition. The central hypothesis is that MSC-LC will be demonstrate high feasibility and acceptability as well as preliminary efficacy in reducing lung cancer stigma and promoting self-compassion.

02

Conditions studied

  • Lung Cancer

Keywords

  • stigma
  • self-compassion
  • pilot
  • adaptation
03

In context

Lung Neoplasms

5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.

This study's enrollment of 79 is above the median of 60 across 3,656 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Loyola Marymount University is the lead sponsor of 9 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Is at least 18 years of age as per self report;
  • Has a confirmed lung cancer diagnosis, as per self-report and confirmed by clinician judgment or medical record note;
  • Endorses elevated levels of lung cancer stigma (scores >37.5 on the Lung Cancer Stigma Inventory)
  • Able to read and respond to questions in English

Exclusion criteria

Exclusion Criteria:

  • Inability to understand study procedures or process, or significant personality dysfunction likely to interfere with study participation, as per study clinician's judgment
  • Completed a course of Mindful Self-Compassion or an equivalent meditation training in the last year
  • Use of antidepressant, anxiolytic, antipsychotic, or mood stabilizing medication(s) for which the dose has been initiated or changed within the 8 weeks prior to study entry
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
79 participants (actual)

Study arms

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

    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.

    Behavioral: Mindful Self-Compassion for Lung Cancer (MSC-LC)

  • Active comparator
    Enhanced standard of care with waitlist

    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.

    Other: Enhanced standard of care with waitlist

Interventions

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

    The overall goal of this 10-week, group-based, virtually-delivered, psychosocial intervention is to enhance recognition and responsiveness to difficult thoughts and emotions and to build self-compassion skills that facilitate patients' ability to turn inward to those thoughts and feelings with mindfulness, connectedness, and self-kindness. Each weekly session is designed to be 90 minutes and follows an agenda with highly structured scripts covering self-compassion topics (e.g., pain of disconnection, listening with compassion), which are carefully organized to build upon one another. In each session, didactic topics (e.g., "What is self-compassion?") taught by trained interventionists lead into guided experiential learning practices (e.g., guided meditation), which are then followed by inquiry into the participants' direct experiences of the practices. The treatment manual is adapted based on the Mindful Self-Compassion Teacher Guide (from the Center for Mindful Self-Compassion).

  • OtherEnhanced standard of care with waitlist

    Participants in the enhanced standard of care control condition will be provided with an information sheet from the NCI about how to find helpful organizations and resources in their community. Self-report will be used to describe any supportive care services pursued by the participant. Additionally, control participants will be added to a waiting list for receiving the MSC-LC intervention program. After completing all questionnaire assessments (16 weeks following study entry), the study team will offer the MSC-LC intervention program to participants on the waiting list.

06

What researchers measure

Primary outcomes

  1. Lung Cancer Stigma Inventory

    The Lung Cancer Stigma Inventory is a self-report questionnaire of lung cancer stigma, which includes 25 items rated on a 5-point Likert scale. Scores range from 25-125, with higher scores indicating higher lung cancer stigma.

    Time frame: Study Entry, 5 weeks (mid-intervention), 10 weeks (post-intervention; primary outcome), 16 weeks (long-term follow-up)

Secondary outcomes

  1. Patient Health Questionnaire-8

    The Patient Health Questionnaire-8 is a self-report questionnaire of depressive symptoms, which includes 8 items rated on a 4-point Likert scale. Scores range from 0-24, with higher scores indicating higher depressive symptoms.

    Time frame: Study Entry, 5 weeks (mid-intervention), 10 weeks (post-intervention), 16 weeks (long-term follow-up)

  2. Generalized Anxiety Disorder-7

    The Generalized Anxiety Disorder-7 is a self-report questionnaire of anxiety symptoms, which includes 7 items rated on a 4-point Likert scale. Scores range from 0-21, with higher scores indicating higher anxiety symptoms.

    Time frame: Study Entry, 5 weeks (mid-intervention), 10 weeks (post-intervention), 16 weeks (long-term follow-up)

  3. Self-Compassion Scale

    The Self-Compassion Scale is a self-report questionnaire of self-compassion, which includes 26 items rated on a 5-point Likert scale. Scores range from 26-130, with higher scores indicating higher self-compassion.

    Time frame: Study Entry, 5 weeks (mid-intervention), 10 weeks (post-intervention), 16 weeks (long-term follow-up)

  4. Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being, meaning and peace subscales

    The Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being is a self-report questionnaire on meaning and peace, which includes 8 items rated on a 5-point Likert scale. Scores range from 0-48, with higher scores indicating higher self-reported meaning and peace during chronic illness.

    Time frame: Study Entry, 5 weeks (mid-intervention), 10 weeks (post-intervention), 16 weeks (long-term follow-up)

Other outcomes

  1. Number of intervention sessions that each consented participant attended

    This measure will be calculated as a count of sessions that each consented participant in the MSC-LC intervention attended. It will be used as a metric of acceptability of the intervention.

    Time frame: 10 weeks (post-intervention)

  2. Treatment fidelity

    This measure will be calculated as a proportion of the number of components within an intervention session that the interventionists delivered (assessed via audio recording) over the number of pre-determined components that they were meant to deliver, per the interventionist manual.

    Time frame: Weekly throughout the intervention from study entry to post-intervention (10 weeks)

07

Study locations

1 site
  • Loyola Marymount University
    Los Angeles, California 90045, United States
08

References and documents

Publications

  • Williamson TJ, Brymwitt WM, Gilliland J, Carter-Bawa L, Mao JJ, Lynch KA, Emard N, Omachi S, Jacobs RL, Tefera MY, Reese MT, Ostroff JS. Mindful self-compassion for lung cancer (MSC-LC): Incorporating perspectives of lung cancer patients, clinicians, and researchers to create an adapted intervention to reduce lung cancer stigma. Transl Behav Med. 2025 Jan 16;15(1):ibae074. doi: 10.1093/tbm/ibae074. PubMed 39868945 ↗
  • Williamson TJ, Brymwitt WM, Ostroff JS, Carter-Bawa L, Germer CK, Hickman SD, Mao JJ, Hamann HA, Riley KE, Studts JL, Reese MT. Mindful self-compassion to reduce stigma among individuals diagnosed with lung cancer (MSC-LC): a pilot study protocol for a parallel-group, randomized controlled trial. Pilot Feasibility Stud. 2026 Mar 20;12(1):57. doi: 10.1186/s40814-026-01808-8. PubMed 41862990 ↗

Individual participant data

Plan to share: Yes — Loyola Marymount University supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication.

Access criteria: Requests may be made to: timothy.williamson@lmu.edu

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2024 to primary completion in Jan 2026, 20 months.

Of 864 non-industry interventional studies with no phase under Lung Neoplasms, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 68. This study's 20 months is below that.

Counting every sponsor, half of 915 studies reached it within 34 months; a quarter within 15 and three quarters within 67.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 20, 2023
First posted
Jan 5, 2024
StartActual
May 6, 2024
Primary completionActual
Jan 22, 2026
CompletionActual
Jan 22, 2026
Last update
Apr 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06191939
Lead sponsor
Loyola Marymount University
Responsible party
Timothy Williamson (Assistant Professor, Loyola Marymount University) — Principal investigator
First posted
Jan 5, 2024
Start date
May 6, 2024
Primary completion
Jan 22, 2026
Completion
Jan 22, 2026
Last update
Apr 13, 2026

Study contacts

Timothy J Williamson, Ph.D., MPH
principal investigator · Loyola Marymount University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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