Lung CancerNCT06286592
LUNGevity: Lung Cancer Stigma Community Based Participatory Research
A study testing Ultra-brief mindfulness intervention video, Forgiveness video and ACT values video in people with Lung Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Ultra-brief mindfulness intervention video, Forgiveness video and ACT values video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2024to 13 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Graduate School of Applied and Professional Psychology
Piscataway, New Jersey, 08854
About this study
Official title: CBPR Intervention to Decrease Lung Cancer Stigma and Health Disparities (LUNGevity Lung Cancer Stigma Reduction)
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Ultra-brief mindfulness intervention video, Forgiveness video, ACT values video
- Keywords
- community-based participatory research, community advisory board, stimga, cancer, smoking cessation
- Medical subject headings
- Lung Neoplasms, Neoplasms, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-brief mindfulness intervention videoBehavioural
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.
Forgiveness videoBehavioural
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.
ACT values videoBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Conditions 1, 2 & 3 | Experimental | 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. Receives: Behavioral: Ultra-brief mindfulness intervention video; Behavioral: Forgiveness video; Behavioral: ACT values video |
| Conditions 1 & 2 | Experimental | Condition 1 = Brief Mindfulness Video Condition 2 = Forgiveness Video
*Details of the specific interventions will be selected in collaboration with the Community Advisory Board. Receives: Behavioral: Ultra-brief mindfulness intervention video; Behavioral: Forgiveness video |
| Condition 1 | Experimental | Condition 1 = Brief Mindfulness Video
*Details of the specific interventions will be selected in collaboration with the Community Advisory Board. Receives: Behavioral: Ultra-brief mindfulness intervention video |
| Conditions 1 & 3 | Experimental | Condition 1 = Brief Mindfulness Video Condition 3 = ACT Video
*Details of the specific interventions will be selected in collaboration with the Community Advisory Board. Receives: Behavioral: Ultra-brief mindfulness intervention video; Behavioral: ACT values video |
| Conditions 2 & 3 | Experimental | Condition 2 = Forgiveness Video Condition 3 = ACT Video
*Details of the specific interventions will be selected in collaboration with the Community Advisory Board. Receives: Behavioral: Forgiveness video; Behavioral: ACT values video |
| Condition 2 | Experimental | Condition 2 = Forgiveness Video
*Details of the specific interventions will be selected in collaboration with the Community Advisory Board. Receives: Behavioral: Forgiveness video |
| Condition 3 | Experimental | Condition 3 = ACT Video
*Details of the specific interventions will be selected in collaboration with the Community Advisory Board. Receives: Behavioral: ACT values video |
| No Intervention | No intervention | Treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Cancer Stigma Inventory (LCSI)
Both perceived/felt stigma (negative appraisal and devaluation from others) and internalized/self (internalization of perceived stigma) stigma from having lunch cancer.
Measured: 1 year
Tobacco use quit likelihood
If current smoker, assessing subjectively reported quit likelihood on a 0 (meaning not likely) to 10 (meaning extremely likely) scale.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start31 Jul 2024
- Primary completion13 Apr 2026
- Study completion13 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristen E. Riley, Ph.D., Rutgers, The State University of New Jersey
- Investigators
- Kristen E Riley, PhD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286592
- Sponsor's protocol ID
- Pro2023002053
- Status last verified
- Apr 2026
- First submitted
- 7 Dec 2023
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant age range and status collected during trial will be reported after deidentification.
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.
PubMed 26238037Sanchez 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.
PubMed 33823072Riley 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.
PubMed 28553905Vrinten 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.
PubMed 31185949Hatzenbuehler 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.
PubMed 23488505
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CBPR Intervention to Decrease Lung Cancer Stigma and Health Disparities (LUNGevity Lung Cancer Stigma Reduction)
- ClinicalTrials.gov ID
- NCT06286592
- Acronym / sponsor ID
- Pro2023002053
- Conditions
- Lung Cancer
- Keywords
- community-based participatory research, community advisory board, stimga, cancer, smoking cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 13 Apr 2026 (actual)
- Study completion
- 13 Apr 2026 (actual)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conditions 1, 2 & 3 | Experimental | Behavioral: Ultra-brief mindfulness intervention video, Behavioral: Forgiveness video, Behavioral: ACT values videoCondition 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. |
| Conditions 1 & 2 | Experimental | Behavioral: Ultra-brief mindfulness intervention video, Behavioral: Forgiveness videoCondition 1 = Brief Mindfulness Video Condition 2 = Forgiveness Video *Details of the specific interventions will be selected in collaboration with the Community Advisory Board. |
| Condition 1 | Experimental | Behavioral: Ultra-brief mindfulness intervention videoCondition 1 = Brief Mindfulness Video *Details of the specific interventions will be selected in collaboration with the Community Advisory Board. |
| Conditions 1 & 3 | Experimental | Behavioral: Ultra-brief mindfulness intervention video, Behavioral: ACT values videoCondition 1 = Brief Mindfulness Video Condition 3 = ACT Video *Details of the specific interventions will be selected in collaboration with the Community Advisory Board. |
| Conditions 2 & 3 | Experimental | Behavioral: Forgiveness video, Behavioral: ACT values videoCondition 2 = Forgiveness Video Condition 3 = ACT Video *Details of the specific interventions will be selected in collaboration with the Community Advisory Board. |
| Condition 2 | Experimental | Behavioral: Forgiveness videoCondition 2 = Forgiveness Video *Details of the specific interventions will be selected in collaboration with the Community Advisory Board. |
| Condition 3 | Experimental | Behavioral: ACT values videoCondition 3 = ACT Video *Details of the specific interventions will be selected in collaboration with the Community Advisory Board. |
| No Intervention | No intervention | –Treatment as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultra-brief mindfulness intervention videoDetails 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. | Behavioural | Condition 1, Conditions 1 & 2, Conditions 1 & 3, Conditions 1, 2 & 3 |
| Forgiveness videoDetails 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. | Behavioural | Condition 2, Conditions 1 & 2, Conditions 1, 2 & 3, Conditions 2 & 3 |
| ACT values videoDetails 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. | Behavioural | Condition 3, Conditions 1 & 3, Conditions 1, 2 & 3, Conditions 2 & 3 |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Background: PubMed 26238037Collins 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.
- Background: PubMed 33823072Sanchez 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.
- Background: PubMed 28553905Riley 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.
- Background: PubMed 31185949Vrinten 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.
- Results publication: PubMed 23488505Hatzenbuehler 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.
- CDC Tobacco-related mortalityLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Participant age range and status collected during trial will be reported after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen E Riley, PhD principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra-brief mindfulness intervention video, Forgiveness video and ACT values video in people with Lung Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Cancer Stigma Inventory (LCSI) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06286592, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.