Clinical trial

Implementing a Virtual Tobacco Treatment in Community Oncology Practices: "Smoke Free Support Study 2.0"

Name
EAQ171CD
Description
This phase II trial studies how well smoking cessation treatment plans work in tobacco-dependent cancer patients when delivered virtually as part of their cancer care in community oncology practices. Virtual information and counseling sessions may help cancer patients quit smoking.
Trial arms
Trial start
2019-08-01
Estimated PCD
2023-12-31
Trial end
2023-12-31
Status
Completed
Phase
Early phase I
Treatment
Behavioral, Psychological or Informational Intervention
Receive information about tobacco cessation
Arms:
Arm A (smoking assessment, quitting advice, Quitline referral)
Nicotine Replacement
Given NRT patch or lozenge (or both)
Arms:
Arm B (virtual counseling sessions, NRT)
Other names:
Nicotine Replacement Therapy, NRT
Quality-of-Life Assessment
Ancillary studies
Arms:
Arm A (smoking assessment, quitting advice, Quitline referral), Arm B (virtual counseling sessions, NRT)
Other names:
Quality of Life Assessment
Survey Administration
Ancillary studies
Arms:
Arm B (virtual counseling sessions, NRT)
Tobacco Cessation Counseling
Receive virtual tobacco cessation counseling
Arms:
Arm B (virtual counseling sessions, NRT)
Size
415
Primary endpoint
7-day point-prevalence tobacco abstinence by saliva cotinine or expired air carbon monoxide (CO)
At 6 months
Eligibility criteria
Inclusion Criteria: * STAFF ELIGIBILITY CRITERIA: * Must be English speaking. * Must be employed at NCI Community Oncology Research Program (NCORP) site for at least three months. * PATIENT ELIGIBILITY CRITERIA STEP 0: * Patient presenting with any type of cancer with a date of diagnosis within the past 4 months. Recurrence, diagnosed within the last 4 months, of tumors in patients with past cancer diagnoses will be considered eligible. Patients with a new primary cancer, diagnosed within the last 4 months, who have been treated previously for other types of cancer will also be considered eligible. ?In situ? cancers, diagnosed within the past 4 months, will also be considered eligible. * Patient must be a current smoker. Current smoker is defined as any cigarette smoking (even a puff) in the past 30 days. * Patient must be fluent in both, written and spoken, English or both, written and spoken, Spanish. * Patient must have telephone, e-mail access, and have access to the internet with a camera-enabled device (e.g., smartphone, tablet, computer, laptop with a webcam/camera) * NOTE: The restriction to those with web and e-mail access is based on the primary intention of the study; to assess the implementation of the virtual intervention in the NCORP network. * ELIGIBILITY CRITERIA STEP 1: Patient must still meet all criteria outlined in step 0. * ELIGIBILITY STEP 2 (RANDOMIZATION): Patient must have completed baseline survey in Eastern Cooperative Oncology Group-American College of Radiology Imaging Network (ECOG-ACRIN) Cancer Research Group Systems for Easy Entry of Patient Reported Outcomes (EASEEPRO) within 1 month (30 days) of the date of informed consent (Step 1). Exclusion Criteria: * Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 3 or above, or is deemed medically unable to participate by study investigators or oncology clinician (i.e., referral to hospice). * Patient has no intention to receive their cancer care or monitoring at an NCORP community cancer site.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 415, 'type': 'ACTUAL'}}
Updated at
2024-01-19

1 organization

1 product

1 abstract

5 indications

Indication
Smoking
Indication
Cancer
Abstract
Smoking cessation support and knowledge among newly diagnosed individuals at community cancer centers (ECOG-ACRIN trial EAQ171CD).
Org: Massachusetts General Hospital, Memorial Sloan Kettering Cancer Center, Brown University–ECOG-ACRIN Biostatistics Center, Brown University - Lifespan Cancer Institute, University of Massachusetts Lowell,