Lung Cancer
Conditions
Keywords
stigma, self-compassion, pilot, adaptation
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.
Interventions
BEHAVIORALMindful 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).
OTHEREnhanced 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.
Sponsors
Loyola Marymount University
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lung Cancer Stigma Inventory | Study Entry, 5 weeks (mid-intervention), 10 weeks (post-intervention; primary outcome), 16 weeks (long-term follow-up) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-8 | Study Entry, 5 weeks (mid-intervention), 10 weeks (post-intervention), 16 weeks (long-term follow-up) | 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. |
| Generalized Anxiety Disorder-7 | Study Entry, 5 weeks (mid-intervention), 10 weeks (post-intervention), 16 weeks (long-term follow-up) | 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. |
| Self-Compassion Scale | Study Entry, 5 weeks (mid-intervention), 10 weeks (post-intervention), 16 weeks (long-term follow-up) | 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. |
| 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) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTimothy J Williamson, Ph.D., MPH
Loyola Marymount University
Outcome results
None listed