This clinical trial studies whether a smoking cessation intervention, Promoting Recovery in Diverse Experiences-Quitting Tobacco (PRIDE QUIT), improves quit rates among transgender and gender expansive (TGE) individuals. Smoking remains the leading cause of preventable death in the United States. Tobacco use among lesbian, gay, bisexual, and transgender individuals is almost double the rate in the general population. This could be related to stigma, discrimination, and other gender minority stressors. PRIDE QUIT treatment sessions are adapted to meet the unique needs of TGE individuals. Participants set a quit date during the PRIDE QUIT sessions and receive transdermal nicotine patches in support of quit efforts, which may help TGE individuals quit smoking. Participating in PRIDE QUIT may improve quit rates among TGE individuals.
Additional locations may be listed on ClinicalTrials.gov for NCT06654414.
Locations matching your search criteria
United States
Massachusetts
Boston
Massachusetts General Hospital Cancer CenterStatus: Active
Contact: Conall O'Cleirigh
Phone: 617-927-6033
PRIMARY OBJECTIVES:
Ia. Explore the ways in which gender minority stressors and associated anxiety/depression compromise smoking cessation among TGE individuals and identify necessary changes to Quitting Tobacco (QUIT).
Ib. Explore relationships among gender minority stress, mental health, and smoking, as well as anticipated barriers to intervention implementation, in individual interviews with Fenway Health primary care and behavioral health providers who work with TGE patients (n =< 8).
II. Based on Aim 1 findings, adapt the QUIT intervention for TGE individuals.
III. Conduct a pilot randomized controlled trial (RCT) of the adapted intervention.
OUTLINE:
AIM 1A: Participants complete a survey over 15-20 minutes and an individual interview over 1-1.5 hours on study.
AIM 1B: Providers complete a questionnaire over 15-20 minutes and an individual interview over 1-1.5 hours on study.
AIM 3: Participants are randomized to 1 of 2 groups.
GROUP I (PRIDE QUIT): Participants attend one psychoeducation session covering cessation and withdrawal, support for quitting smoking, discussion of health consequences of quitting relevant to TGE individuals, discussion of past quit experiences, and motivation for cessation on study. Participants then attend weekly PRIDE QUIT treatment sessions over 1 hour for 6-10 sessions and set a quit date around session 4-6 on study. Participants also receive transdermal nicotine patches (TNP) for 8 weeks prior to the quit session on study. Additionally, participants may undergo mouth swab sample collection throughout the study.
GROUP II (ENHANCED TREATMENT AS USUAL [ETAU]): Participants attend one psychoeducation session covering cessation and withdrawal, support for quitting smoking, discussion of health consequences of quitting relevant to TGE individuals, discussion of past quit experiences, and motivation for cessation on study. Participants set a quit date at the end of the psychoeducation session and receive American Cancer Society cessation resources and TNP prior to the quit date on study. Participants are offered the option to complete the PRIDE QUIT intervention at the end of the study. Additionally, participants may undergo mouth swab sample collection throughout the study.
After completion of study intervention, participants are followed up at 3 months.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorConall O'Cleirigh
