Clinical trial · Interventional
Implementing a Virtual Tobacco Treatment for Cancer Patients in Community Oncology Practices
Implementing a Virtual Tobacco Treatment in Community Oncology Practices: "Smoke Free Support Study 2.0"
NCT03808818CI-TRIAL-00087345completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma In Situ | Carcinoma In Situ | ONTOLOGY_EXACT | 0.98 |
| Current Smoker | — | UNRESOLVED | — |
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Primary Neoplasm | Primary Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Recurrent Neoplasm | Neoplasm | CURATED_BROADER | 0.78 |
| Smoking Cessation | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral, Psychological or Informational Intervention | Other | — | UNRESOLVED |
| Nicotine Replacement | Drug | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
| Tobacco Cessation Counseling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A (smoking assessment, quitting advice, Quitline referral)
- description
- Patients receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the NCI Smoking Quitline.
- interventionNames
- Other: Behavioral, Psychological or Informational Intervention
- Other: Quality-of-Life Assessment
- type
- EXPERIMENTAL
- label
- Arm B (virtual counseling sessions, NRT)
- description
- Patients receive an initial virtual counseling session with a study-designated tobacco treatment coach via MGH TeleHealth over 40 minutes and up to 10 more virtual counseling sessions over 15 minutes for approximately 6 months. Patients also receive up to 12 weeks of NRT (patch and lozenge combined or alone).
- interventionNames
- Drug: Nicotine Replacement
- Other: Quality-of-Life Assessment
- Other: Survey Administration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDGoshe BM, Rasmussen AW, Wagner LI, Sicks JD, Gareen IF, Carlos RC, Herman BA, Walter AW, Regan S, Levy DE, Mahon I, Muzikansky A, Neil JM, Lui M, Dilip D, Malloy L, Gonzalez I, Finkelstein-Fox L, McCann C, Perez E, Ostroff JS, Park ER. Study protocol for a hybrid type 1 effectiveness-implementation trial testing virtual tobacco treatment in oncology practices [Smokefree Support Study 2.0]. BMC Public Health. 2022 Jul 15;22(1):1359. doi: 10.1186/s12889-022-13631-w. PMID 35841024