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

NCT ID: NCT06191939

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-06
• Study Completion Date: 2026-01-12

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.

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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).

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.

Group Type: ACTIVE_COMPARATOR

Enhanced standard of care with waitlist

Intervention Type: 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.

Interventions

Mindful 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).

Intervention Type: BEHAVIORAL

Enhanced 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.

Intervention Type: OTHER

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Loyola Marymount University

OTHER

Sponsor Role: lead

Responsible Party

Timothy Williamson

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Timothy J Williamson, Ph.D., MPH

Role: PRINCIPAL_INVESTIGATOR

Loyola Marymount University

Locations

Loyola Marymount University

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Timothy J Williamson, Ph.D., MPH

Role: CONTACT

timothy.williamson@lmu.edu

310-568-6148

Facility Contacts

Timothy J Williamson, Ph.D., MPH

Role: primary

timothy.williamson@lmu.edu

310-568-6148

Other Identifiers

R00CA256351

Identifier Type: NIH

Identifier Source: secondary_id

View Link

LMU IRB 2022 SU 27-R

Identifier Type: -

Identifier Source: org_study_id