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| ID | Type | Description | Link |
|---|---|---|---|
| R00CA256351 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindful Self-Compassion for Lung Cancer (MSC-LC) | Experimental | 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. |
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| Enhanced standard of care with waitlist | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindful Self-Compassion for Lung Cancer (MSC-LC) | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Study Entry, 5 weeks (mid-intervention), 10 weeks (post-intervention; primary outcome), 16 weeks (long-term follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Study Entry, 5 weeks (mid-intervention), 10 weeks (post-intervention), 16 weeks (long-term follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 weeks (post-intervention) |
| Treatment fidelity |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy J Williamson, Ph.D., MPH | Loyola Marymount University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loyola Marymount University | Los Angeles | California | 90045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39868945 | Background | 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. | |
| 41862990 | Background | 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. |
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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.
Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication.
Requests may be made to: timothy.williamson@lmu.edu
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D057545 | Social Stigma |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D014850 | Waiting Lists |
| ID | Term |
|---|---|
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| Enhanced standard of care with waitlist | Other | 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. |
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| 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. | Study Entry, 5 weeks (mid-intervention), 10 weeks (post-intervention), 16 weeks (long-term follow-up) |
| 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. | Study Entry, 5 weeks (mid-intervention), 10 weeks (post-intervention), 16 weeks (long-term follow-up) |
| 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. | Study Entry, 5 weeks (mid-intervention), 10 weeks (post-intervention), 16 weeks (long-term follow-up) |
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. |
| Weekly throughout the intervention from study entry to post-intervention (10 weeks) |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012919 | Social Behavior |
| D001519 | Behavior |