LUNGevity: Lung Cancer Stigma Community Based Participatory Research

NCT ID: NCT06286592

Last Updated: 2024-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-31

Study Completion Date

2025-11-30

Brief Summary

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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

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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

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Ultra-brief mindfulness intervention video

Intervention Type BEHAVIORAL

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 video

Intervention Type BEHAVIORAL

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 video

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Ultra-brief mindfulness intervention video

Intervention Type BEHAVIORAL

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 video

Intervention Type BEHAVIORAL

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.

Condition 1

Condition 1 = Brief Mindfulness Video

\*Details of the specific interventions will be selected in collaboration with the Community Advisory Board.

Group Type EXPERIMENTAL

Ultra-brief mindfulness intervention video

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Ultra-brief mindfulness intervention video

Intervention Type BEHAVIORAL

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 video

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Forgiveness video

Intervention Type BEHAVIORAL

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 video

Intervention Type BEHAVIORAL

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.

Condition 2

Condition 2 = Forgiveness Video

\*Details of the specific interventions will be selected in collaboration with the Community Advisory Board.

Group Type EXPERIMENTAL

Forgiveness video

Intervention Type BEHAVIORAL

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.

Condition 3

Condition 3 = ACT Video

\*Details of the specific interventions will be selected in collaboration with the Community Advisory Board.

Group Type EXPERIMENTAL

ACT values video

Intervention Type BEHAVIORAL

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

Treatment as usual.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Kristen E. Riley, Ph.D.

Assistant Professor, Clinical Psychology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristen E Riley, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Central Contacts

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Kristen E Riley, PhD

Role: CONTACT

484-459-2004

References

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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.

Reference Type BACKGROUND
PMID: 26238037 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33823072 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28553905 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31185949 (View on PubMed)

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.

Reference Type RESULT
PMID: 23488505 (View on PubMed)

Other Identifiers

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Pro2023002053

Identifier Type: -

Identifier Source: org_study_id

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