Comprehensive Tobacco Cessation for Cancer Patients and Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVirginia Commonwealth University
About this trial
The purpose of this research study is to learn how best to incorporate tobacco cessation treatment into clinical care for cancer patients, survivors, and caregivers.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of signed and dated informed consent form
Stated willingness to comply with study procedures and availability for the duration of the study
Have a documented history of cancer of any type, whether active or in remission
Identify as a current or recently-quit tobacco user
Disqualifiers
Not a VCUHealth patient
Non English-speaking
Trial design
Design model
Single group
Treatments tested in this trial
Behavioral counseling for tobacco cessation
BehavioralParticipants can choose to receive behavioral counseling in group v. individual format: Group Sessions: Participants will be offered the opportunity to attend 6 weekly 60-90 minute sessions Individual Sessions: Participants will be offered the opportunity to attend up to 12 30-45 minute sessions on a schedule mutually agreed upon between interventionist and participant
Treatment groups
75 Participants
are divided into 2 treatment groupsGroup A: Behavioral Counseling for Tobacco CessationExperimental treatment 1 intervention
Group B: Observational ArmNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Feasibility: Consent rate
The number of individuals who consented to participate compared to the number of individuals approached for study participation.
Time frame
At enrollment visit2
Feasibility: Barriers to participation
Reasons for refusal will be collected for eligible individuals who do not enroll in the study.
Time frame
At recruitment visit3
Acceptability: Participant satisfaction
Participant satisfaction ratings will be evaluated utilizing a questionnaire assessing participant satisfaction with the behavioral intervention (if applicable) and/or VCUHS pharmacotherapy management (if applicable) will be administered at each follow-up timepoint.
Time frame
Week 64
Acceptability: Participant satisfaction
Participant satisfaction ratings will be evaluated utilizing a questionnaire assessing participant satisfaction with the behavioral intervention (if applicable) and/or VCUHS pharmacotherapy management (if applicable) will be administered at each follow-up timepoint.
Time frame
Week 12Other outcomes
1
Change in tobacco use
Self-reported change in number of cigarettes smoked
Time frame
Baseline to Week 122
Change in tobacco use
Self-reported change in number of cigarettes smoked
Time frame
Baseline to Week 24Sponsors and contacts
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Source ClinicalTrials.gov