Clinical trial NCT06191939: Adapting and Testing a Novel Self-Compassion Intervention to Reduce Lung Cancer Stigma
Official title: Adapting and Testing a Novel Self-Compassion Intervention to Reduce Lung Cancer Stigma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: stigma
self-compassion
pilot
adaptation
Lead sponsor: Loyola Marymount University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-01-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Lung Cancer Stigma Inventory
timeFrame: Study Entry, 5 weeks (mid-intervention), 10 weeks (post-intervention; primary outcome), 16 weeks (long-term follow-up)
Secondary outcomes:
measure: Patient Health Questionnaire-8
timeFrame: Study Entry, 5 weeks (mid-intervention), 10 weeks (post-intervention), 16 weeks (long-term follow-up)
measure: Generalized Anxiety Disorder-7
timeFrame: Study Entry, 5 weeks (mid-intervention), 10 weeks (post-intervention), 16 weeks (long-term follow-up)
measure: Self-Compassion Scale
timeFrame: Study Entry, 5 weeks (mid-intervention), 10 weeks (post-intervention), 16 weeks (long-term follow-up)
measure: Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being, meaning and peace subscales
timeFrame: Study Entry, 5 weeks (mid-intervention), 10 weeks (post-intervention), 16 weeks (long-term follow-up)
Other outcomes:
measure: Number of intervention sessions that each consented participant attended
timeFrame: 10 weeks (post-intervention)
measure: Treatment fidelity
timeFrame: Weekly throughout the intervention from study entry to post-intervention (10 weeks)
Locations:
city: Los Angeles
country: United States
facility: Loyola Marymount University
state: California
Study officials:
affiliation: Loyola Marymount University
name: Timothy J Williamson, Ph.D., MPH
role: PRINCIPAL_INVESTIGATOR
References: