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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Behavioral: Mindful Self-Compassion for Lung Cancer (MSC-LC); Other: Enhanced standard of care with waitlist

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Timothy J Williamson, Ph.D., MPH; Phone Number: 310-568-6148; Email: timothy.williamson@lmu.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90045
      • Recruiting
      • Loyola Marymount University
      • Contact: Timothy J Williamson, Ph.D., MPH; Phone Number: 310-568-6148; Email: timothy.williamson@lmu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); 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).
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)
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)

Other Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Loyola Marymount University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Timothy J Williamson, Ph.D., MPH, Loyola Marymount University

Study record dates

Study Major Dates

• Study Start (Estimated): February 19, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: December 20, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: stigma; self-compassion; adaptation; pilot
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: LMU IRB 2022 SU 27-R; R00CA256351 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication.
• IPD Sharing Access Criteria: Requests may be made to: timothy.williamson@lmu.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No