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

NCT06191939 | Completed

• 2 other identifiers: LMU IRB 2022 SU 27-RR00CA256351
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Keywords

stigma; self-compassion; pilot; adaptation

Outcome Measures

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.

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

Secondary Outcomes (4)

• Patient Health Questionnaire-8

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

• Generalized Anxiety Disorder-7

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

• Self-Compassion Scale

  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

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

Other Outcomes (2)

• Number of intervention sessions that each consented participant attended

  10 weeks (post-intervention)

• Treatment fidelity

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

Study Arms (2)

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.

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

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.

Other: Enhanced standard of care with waitlist

Interventions

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).

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

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.

Enhanced standard of care with waitlist

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to understand study procedures or informed consent 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

Sponsors & Collaborators

• Loyola Marymount University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Loyola Marymount University

Los Angeles, California, 90045, United States

Location

Related Publications (2)

• 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.

  PMID: 39868945 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. doi: 10.1186/s40814-026-01808-8. Online ahead of print.

  PMID: 41862990 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Social Stigma

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Timothy J Williamson, Ph.D., MPH

  Loyola Marymount University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 5, 2024
• Study Start: May 6, 2024
• Primary Completion: January 22, 2026
• Study Completion: January 22, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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

Locations

US (1)