LUNGevity: Lung Cancer Stigma Community Based Participatory Research

Trial Title: LUNGevity: Lung Cancer Stigma Community Based Participatory Research

NCT ID: NCT06286592

Condition: Lung Cancer

Conditions: Official terms:
Lung Neoplasms

Conditions: Keywords:
community-based participatory research
community advisory board
stimga
cancer
smoking cessation

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Factorial Assignment

Intervention model description: Details of the specific interventions will be selected in collaboration with the Community Advisory Board. Then, in a Phase IB trial, we will use a MOST design to assign patients to promising intervention components, combining them and altering exposure time, measuring preliminary effects of possible components of interventions. Details of the specific interventions will be selected in collaboration with the Community Advisory Board.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Ultra-brief mindfulness intervention video
Description: Details of the specific intervention will be selected in collaboration with the Community Advisory Board. Then, in a Phase IB trial, we will use a MOST design to assign patients to promising intervention components, combining them and altering exposure time, measuring preliminary effects of possible components of interventions. Details of the specific interventions will be selected in collaboration with the Community Advisory Board.
Arm group label: Condition 1
Arm group label: Conditions 1 & 2
Arm group label: Conditions 1 & 3
Arm group label: Conditions 1, 2 & 3

Intervention type: Behavioral
Intervention name: Forgiveness video
Description: Details of the specific intervention will be selected in collaboration with the Community Advisory Board. Then, in a Phase IB trial, we will use a MOST design to assign patients to promising intervention components, combining them and altering exposure time, measuring preliminary effects of possible components of interventions. Details of the specific interventions will be selected in collaboration with the Community Advisory Board.
Arm group label: Condition 2
Arm group label: Conditions 1 & 2
Arm group label: Conditions 1, 2 & 3
Arm group label: Conditions 2 & 3

Intervention type: Behavioral
Intervention name: ACT values video
Description: Details of the specific intervention will be selected in collaboration with the Community Advisory Board. Then, in a Phase IB trial, we will use a MOST design to assign patients to promising intervention components, combining them and altering exposure time, measuring preliminary effects of possible components of interventions. Details of the specific interventions will be selected in collaboration with the Community Advisory Board.
Arm group label: Condition 3
Arm group label: Conditions 1 & 3
Arm group label: Conditions 1, 2 & 3
Arm group label: Conditions 2 & 3

Summary: Lung cancer survival rates are low for intersectional underserved groups. Lung cancer stigma and intersectional stigma related to minoritized group status leads to increased morbidity and mortality and health disparities. Mindfulness interventions have been shown to decrease stigma and the negative impacts of stigma, however, these interventions have never been tested to decrease lung cancer stigma specifically. In this study, the investigators will use Community Based Participatory Research framework and MOST methodology to build and optimize a brief virtual mindfulness intervention to decrease lung cancer stigma, through first building a diverse coalition of lung cancer patients on a participatory action council.

Detailed description: Lung cancer is the deadliest form of cancer, with the five year survival rate being 18.6%. Survival rates are even lower for intersectional underserved groups. Stigma about having lung cancer is very common, with 95% of lung cancer patients reporting lung cancer stigma. Stigma leads to higher rates of depressive symptoms, lower disclosure of smoking, lower likelihood of engaging with smoking cessation services, and decreased likelihood of following through on treatment recommendations. Lung cancer stigma and intersectional stigma related to minoritized group status leads to increased morbidity and mortality and health disparities. Mindfulness interventions have been shown to decrease stigma and the negative impacts of stigma, however, these interventions have never been tested to decrease lung cancer stigma specifically. In this study, the investigators propose an innovative Multiphase Optimization Strategy (MOST) methodology to build and optimize a brief virtual mindfulness intervention to decrease lung cancer stigma. Using an innovative approach that combines Community Based Participatory Research (CBPR) and MOST, the investigators will first build a diverse coalition of lung cancer patients on a participatory action council per CBPR best practice models, with community members as equal stakeholders and part of the research team at every stage of the project. This study aims to: Test mindfulness intervention components for lung cancer stigma in lung cancer patients to improve lung cancer treatment outcomes (i.e., patient-provider communication, willingness to accept referral to tobacco cessation, and quit rates). Assess preliminary efficacy of these interventions on lung cancer stigma among lung cancer patients by race, ethnicity and sexual/gender classification. Explore reach, acceptability and satisfaction of a mindfulness intervention to address lung cancer stigma, with a focus reaching patients in underserved groups (Black, Latinx, LGBTQ+ individuals, and low SES) in order to decrease health disparities and extend the five year survival rate.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Participants must be patients 18 years of age or older with a history of tobacco use to qualify for study inclusion. At least a portion of the participants will also need to be current lung cancer patients. Participants must be able to read and understand English and have normal to corrected vision and hearing. - For the Community Advisory Board (CAB), participants must have been diagnosed with lung cancer, be at least 18 years of age or older, and self-identify as being part of an underrepresented group identity. Exclusion Criteria: - Any potential participants who do not meet the above inclusion criteria will be excluded from the study. - Patients who are under the age of 18 and who do not have a history of tobacco use will be excluded from participating in the study. - Individuals who cannot read or understand English or who do not have normal to corrected vision and hearing will be excluded from the study.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: March 2024

Completion date: November 2025

Lead sponsor:
Agency: Rutgers, The State University of New Jersey
Agency class: Other

Source: Rutgers, The State University of New Jersey

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06286592