Precision Treatment to Promote Smoking Cessation and Survival in Oncology Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorWashington University School of Medicine
About this trial
This study evaluates the feasibility and preliminary effects of precision tobacco treatment, compared to usual care, on promoting tobacco treatment in oncology patients and providers in the oncology care setting. The precision treatment intervention includes personalized tobacco treatment recommendations using the patient's clinical, genetic, and biomarker information. This intervention may increase patient receipt of tobacco treatment, patient medication use, and patient smoking abstinence at 6 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinician from participating oncology/hematology clinic
At least 18 years of age
Can speak and understand English
Patient at participating clinic
Disqualifiers
Active use of smoking cessation medication (within the past 30 days)
Receipt of smoking cessation medication or prescription for smoking cessation medication (within the past 30 days)
Having a contradiction for cNRT or varenicline (allergic reactions, current cardiac problems, pregnancy)
Patients who were deemed by the investigator to be ineligible for participation in the trial
Trial design
Design model
Parallel
Treatments tested in this trial
Usual care
BehavioralUsual care will be informed by practice guidelines (standard of care, brief advice, and guideline awareness).
Precision treatment
BehavioralPrecision treatment will be informed by practice guidelines (standard of care, brief advice, and guideline awareness), plus patient-specific risk feedback and personalized tobacco treatment recommendations using patients' clinical, genetic, and biomarker information, adapted for oncology.
Treatment groups
132 Participants
are divided into 2 treatment groupsGroup A: Usual CareActive comparator 1 intervention
Group B: PrecisionTx-Onc (oncology)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Patient receipt of tobacco treatment medication for smoking cessation
This will be quantified by the proportion of enrolled patients who receive cessation medication.
Time frame
6 months post-intervention2
Patient use of cessation medication
This will be quantified by the proportion of patients taking any cessation medication from time of enrollment through 6 months post-intervention.
Time frame
6 months post-intervention3
Patient smoking abstinence
This will be quantified by the proportion of patients who smoke with bioverified point-prevalent abstinence at 6 months.
Time frame
6 months post-interventionSecondary outcomes
1
Patient quality of life
Quality of life measure will be measured using European Organization for Research and Treatment of Cancer Quality of life Questionnaire-Core 30 (EORTC QLQ-C30). All of the scales and single-item range in score from 0-100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents high quality of life, but a high score for a symptom scale / item represents a high level of symptomatology/problems.
Time frame
6 and 12 months post-intervention2
Patient survival
Probability of survival from the start of intervention
Time frame
6 and 12 months post-intervention3
Patient receipt of recommended tobacco treatment
This will be quantified by the proportion of enrolled patients who received recommended cessation medication.
Time frame
6 months post-intervention4
Patient medication adherence
This will be quantified by the proportion of medication taken among medication prescribed.
Time frame
6 months post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Washington University School of Medicine
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov