NCT06286592

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 29, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

July 31, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2026

Completed
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

December 7, 2023

Last Update Submit

April 14, 2026

Conditions

Lung Cancer

Keywords

community-based participatory researchcommunity advisory boardstimgacancersmoking cessation

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    1 year

Study Arms (8)

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.

Behavioral: Ultra-brief mindfulness intervention videoBehavioral: Forgiveness videoBehavioral: 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.

Behavioral: Ultra-brief mindfulness intervention videoBehavioral: 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.

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.

Behavioral: Ultra-brief mindfulness intervention videoBehavioral: 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.

Behavioral: Forgiveness videoBehavioral: 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.

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.

Behavioral: ACT values video

No Intervention

NO INTERVENTION

Treatment as usual.

Interventions

Ultra-brief mindfulness intervention videoBEHAVIORAL

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 1Conditions 1 & 2Conditions 1 & 3Conditions 1, 2 & 3
Forgiveness videoBEHAVIORAL

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 2Conditions 1 & 2Conditions 1, 2 & 3Conditions 2 & 3
ACT values videoBEHAVIORAL

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 3Conditions 1 & 3Conditions 1, 2 & 3Conditions 2 & 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Graduate School of Applied and Professional Psychology

Piscataway, New Jersey, 08854, United States

Location

Related Publications (5)

  • 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.

    PMID: 26238037BACKGROUND

  • 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.

    PMID: 33823072BACKGROUND

  • 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.

    PMID: 28553905BACKGROUND

  • 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.

    PMID: 31185949BACKGROUND

  • 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.

    PMID: 23488505RESULT

Related Links

MeSH Terms

Conditions

Lung NeoplasmsNeoplasmsSmoking Cessation

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesHealth BehaviorBehavior

Study Officials

  • Kristen E Riley, PhD

    Rutgers, The State University of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Clinical Psychology Department

Study Record Dates

First Submitted

December 7, 2023

First Posted

February 29, 2024

Study Start

July 31, 2024

Primary Completion

April 13, 2026

Study Completion

April 13, 2026

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Participant age range and status collected during trial will be reported after deidentification.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Immediately following publication. No end date.
Access Criteria
Anyone who wishes to access the data.

Locations

US(1)