LUNGevity: Lung Cancer Stigma Community Based Participatory Research

• ClinicalTrials.gov Identifier: NCT06286592
• Recruitment Status: Not yet recruiting
• First Posted: February 29, 2024
• Last Update Posted: March 29, 2024
• Sponsor: Rutgers, The State University of New Jersey
• Information provided by (Responsible Party): Kristen E. Riley, Ph.D., Rutgers, The State University of New Jersey

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Lung Cancer	Behavioral: Ultra-brief mindfulness intervention video; Behavioral: Forgiveness video; Behavioral: ACT values video	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• 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.

• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: CBPR Intervention to Decrease Lung Cancer Stigma and Health Disparities (LUNGevity Lung Cancer Stigma Reduction)
• Estimated Study Start Date: March 2024
• Estimated Primary Completion Date: November 2025
• Estimated Study Completion Date: November 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Conditions 1, 2 & 3; Condition 1 = Brief Mindfulness Video Condition 2 = Forgiveness Video Condition 3 = ACT Video *Details of the specific interventions will be selected in collaboration with the Community Advisory Board.	Behavioral: Ultra-brief mindfulness intervention video; 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.; Behavioral: Forgiveness video; 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.; Behavioral: ACT values video; 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.
Experimental: Conditions 1 & 2; Condition 1 = Brief Mindfulness Video Condition 2 = Forgiveness Video *Details of the specific interventions will be selected in collaboration with the Community Advisory Board.	Behavioral: Ultra-brief mindfulness intervention video; 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.; Behavioral: Forgiveness video; 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.
Experimental: Condition 1; Condition 1 = Brief Mindfulness Video *Details of the specific interventions will be selected in collaboration with the Community Advisory Board.	Behavioral: Ultra-brief mindfulness intervention video; 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.
Experimental: Conditions 1 & 3; Condition 1 = Brief Mindfulness Video Condition 3 = ACT Video *Details of the specific interventions will be selected in collaboration with the Community Advisory Board.	Behavioral: Ultra-brief mindfulness intervention video; 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.; Behavioral: ACT values video; 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.
Experimental: Conditions 2 & 3; Condition 2 = Forgiveness Video Condition 3 = ACT Video *Details of the specific interventions will be selected in collaboration with the Community Advisory Board.	Behavioral: Forgiveness video; 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.; Behavioral: ACT values video; 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.
Experimental: Condition 2; Condition 2 = Forgiveness Video *Details of the specific interventions will be selected in collaboration with the Community Advisory Board.	Behavioral: Forgiveness video; 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.
Experimental: Condition 3; Condition 3 = ACT Video *Details of the specific interventions will be selected in collaboration with the Community Advisory Board.	Behavioral: ACT values video; 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.
No Intervention: No Intervention; Treatment as usual.

Outcome Measures

Primary Outcome Measures :

1. Lung Cancer Stigma Inventory (LCSI) [ Time Frame: 1 year ]
   Both perceived/felt stigma (negative appraisal and devaluation from others) and internalized/self (internalization of perceived stigma) stigma from having lunch cancer.
2. Tobacco use quit likelihood [ Time Frame: 1 year ]
   If current smoker, assessing subjectively reported quit likelihood on a 0 (meaning not likely) to 10 (meaning extremely likely) scale.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Kristen E Riley, PhD; 484-459-2004; kristen.riley@rutgers.edu

Sponsors and Collaborators

Rutgers, The State University of New Jersey

Investigators

• Principal Investigator: Kristen E Riley, PhD; Rutgers, The State University of New Jersey

More Information

Additional Information:

CDC Tobacco-related mortality 

Publications of Results:

Hatzenbuehler ML, Phelan JC, Link BG. Stigma as a fundamental cause of population health inequalities. Am J Public Health. 2013 May;103(5):813-21. doi: 10.2105/AJPH.2012.301069. Epub 2013 Mar 14.

Other Publications:

Collins LM, Kugler KC, Gwadz MV. Optimization of Multicomponent Behavioral and Biobehavioral Interventions for the Prevention and Treatment of HIV/AIDS. AIDS Behav. 2016 Jan;20 Suppl 1(0 1):S197-214. doi: 10.1007/s10461-015-1145-4.

Sanchez V, Sanchez-Youngman S, Dickson E, Burgess E, Haozous E, Trickett E, Baker E, Wallerstein N. CBPR Implementation Framework for Community-Academic Partnerships. Am J Community Psychol. 2021 Jun;67(3-4):284-296. doi: 10.1002/ajcp.12506. Epub 2021 Apr 6.

Riley KE, Ulrich MR, Hamann HA, Ostroff JS. Decreasing Smoking but Increasing Stigma? Anti-tobacco Campaigns, Public Health, and Cancer Care. AMA J Ethics. 2017 May 1;19(5):475-485. doi: 10.1001/journalofethics.2017.19.5.msoc1-1705.

Vrinten C, Gallagher A, Waller J, Marlow LAV. Cancer stigma and cancer screening attendance: a population based survey in England. BMC Cancer. 2019 Jun 11;19(1):566. doi: 10.1186/s12885-019-5787-x.

• Responsible Party: Kristen E. Riley, Ph.D., Assistant Professor, Clinical Psychology Department, Rutgers, The State University of New Jersey
• ClinicalTrials.gov Identifier: NCT06286592
• Other Study ID Numbers: Pro2023002053
• First Posted: February 29, 2024
• Last Update Posted: March 29, 2024
• Last Verified: March 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Participant age range and status collected during trial will be reported after deidentification.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Anyone who wishes to access the data.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kristen E. Riley, Ph.D., Rutgers, The State University of New Jersey:

community-based participatory research; community advisory board; stimga; cancer; smoking cessation

Additional relevant MeSH terms:

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases