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Implementing a Virtual Tobacco Treatment for Cancer Patients in Community Oncology Practices

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ClinicalTrials.gov Identifier: NCT03808818
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carcinoma In Situ Current Smoker Malignant Neoplasm Primary Neoplasm Recurrent Neoplasm Other: Behavioral, Psychological or Informational Intervention Drug: Nicotine Replacement Other: Quality-of-Life Assessment Other: Survey Administration Other: Tobacco Cessation Counseling Phase 2

Detailed Description:

PRIMARY OBJECTIVE:

I. To compare the proportions of participants in the Enhanced Usual Care (EUC) and Virtual Tobacco Treatment (VIT) study arms with biochemically-verified 7-day point-prevalence abstinence from cigarettes at 6-months post enrollment.

SECONDARY OBJECTIVES:

I. Biochemically-verified 7-day point prevalence abstinence at 3-months follow-up.

II. Self-reported 7-day point prevalence cigarette abstinence at 3- and 6-months follow-up.

III. Significant reduction (> 50% reduction in reported number of cigarettes per day) in daily smoking from baseline to 3- and baseline to 6-months follow-up.

IV. Continuous (no self-reported smoking since last survey point) and sustained abstinence at 6 months (cotinine-verified at 3-months and 6-months).

EXPLORATORY OBJECTIVES:

I. To assess the potential effect of known and potential moderators on treatment effectiveness between the two arms.

II. To assess the processes of implementation and dissemination (acceptability, adoption, appropriateness, treatment fidelity, cost effectiveness, penetration/reach, and sustainability) of the investigator's intervention at community oncology sites.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A (Enhanced Usual Care [EUC]): Patients receive an assessment of smoking status and provision of quitting advice through the screening and referral process, and are referred to the National Cancer Institute (NCI) Smoking Quitline.

ARM B (Virtual Intervention Treatment [VIT]): 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 nicotine replacement (NRT) (patch and lozenge combined or alone).

After completion of study, patients may be followed up for 1 year.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 418 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Implementing a Virtual Tobacco Treatment in Community Oncology Practices: "Smoke Free Support Study 2.0"
Actual Study Start Date : April 11, 2019
Estimated Primary Completion Date : February 1, 2024
Estimated Study Completion Date : February 1, 2029

Arm Intervention/treatment
Active Comparator: Arm A (smoking assessment, quitting advice, Quitline referral)
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.
Other: Behavioral, Psychological or Informational Intervention
Receive information about tobacco cessation

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Experimental: Arm B (virtual counseling sessions, NRT)
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).
Drug: Nicotine Replacement
Given NRT patch or lozenge (or both)
Other Names:
  • Nicotine Replacement Therapy
  • NRT

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Survey Administration
Ancillary studies

Other: Tobacco Cessation Counseling
Receive virtual tobacco cessation counseling




Primary Outcome Measures :
  1. 7-day point-prevalence tobacco abstinence by saliva cotinine or expired air carbon monoxide (CO) [ Time Frame: At 6 months ]
    Will define 7-day point-prevalence by saliva cotinine (< 15 ng/ml) or expired air CO (< 10 ppm). All participants who report being quit and no nicotine replacement (NRT) or e-cigarette use will be requested to provide saliva samples, expired air CO will be measured in participants who report being quit and report concurrent NRT or e-cigarette use. If a participant is lost to follow-up or does not provide a saliva or CO sample, they will be considered a current smoker. Chi-square tests will be used to compare the outcomes between treatment groups.


Secondary Outcome Measures :
  1. Biochemically-confirmed 7-day point prevalence abstinence by saliva cotinine or expired air CO [ Time Frame: At 3 months ]
    Will define 7-day point-prevalence by saliva cotinine (< 15 ng/ml) or expired air CO (< 10 ppm). All participants who report being quit and no NRT or e-cigarette use will be requested to provide saliva samples, expired air CO will be measured in participants who report being quit and report concurrent NRT or e-cigarette use. If a participant is lost to follow-up or does not provide a saliva or CO sample, they will be considered a current smoker. Chi-square tests will be used to compare the outcomes between treatment groups.

  2. Self-reported 7-day point prevalence abstinence [ Time Frame: At 3 months ]
    Chi-square tests will be used to compare the outcomes between treatment groups.

  3. Self-reported 7-day point prevalence abstinence [ Time Frame: At 6 months ]
    Chi-square tests will be used to compare the outcomes between treatment groups.

  4. Self-reported continuous tobacco abstinence [ Time Frame: At 6 months ]
    Chi-square tests will be used to compare the outcomes between treatment groups.

  5. Sustained tobacco abstinence at 6 months [ Time Frame: At 6 months ]
    To qualify as a sustained abstinence at 6 months, the participant must qualify as biochemically-verified 7-day point prevalence cigarette abstinence at 3 and 6 months. Chi-square tests will be used to compare the outcomes between treatment groups.


Other Outcome Measures:
  1. Potential effect of sociodemographics on treatment effectiveness [ Time Frame: Up to 6 months ]
    Will test the effects of potential moderator in logistic regression models to determine association with tobacco abstinence. Once a parsimonious multivariate model is developed, treatment arm will be included to test for the effect of the intervention on the moderator. Interactions between the treatment arm and the moderators to indicate the relationship between the moderators and the treatment group on the effectiveness outcomes. Also, generalized estimating equations (GEE) will be used to look at longitudinal models. Multiple comparisons will be accounted for by considering Bonferroni adjustments.

  2. Potential effect of medical and smoking history on treatment effectiveness [ Time Frame: Up to 6 months ]
    Will test the effects of potential moderator in logistic regression models to determine association with tobacco abstinence. Once a parsimonious multivariate model is developed, treatment arm will be included to test for the effect of the intervention on the moderator. Interactions between the treatment arm and the moderators to indicate the relationship between the moderators and the treatment group on the effectiveness outcomes. Also, generalized estimating equations (GEE) will be used to look at longitudinal models. Multiple comparisons will be accounted for by considering Bonferroni adjustments.

  3. Potential effect of cancer variables on treatment effectiveness [ Time Frame: Up to 6 months ]
    Will test the effects of potential moderator in logistic regression models to determine association with tobacco abstinence. Once a parsimonious multivariate model is developed, treatment arm will be included to test for the effect of the intervention on the moderator. Interactions between the treatment arm and the moderators to indicate the relationship between the moderators and the treatment group on the effectiveness outcomes. Also, generalized estimating equations (GEE) will be used to look at longitudinal models. Multiple comparisons will be accounted for by considering Bonferroni adjustments.

  4. Implementation of the intervention at community oncology sites [ Time Frame: Up to 24 months ]
    Will follow Proctor and colleagues' recommended taxonomy for measurement of implementation outcomes. Will measure acceptability (satisfaction with content/delivery), adoption (program uptake), appropriateness (relevance), cost, and treatment fidelity/adaptation and penetration (reach) and sustainability. These implementation outcomes will be assessed with mixed methods using qualitative and quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcomes (acceptability, adoption, appropriateness, fidelity, cost, penetration and sustainability) and conduct treatment group comparisons (i.e., acceptability).

  5. Intervention acceptability (satisfaction with content/delivery) at community oncology sites [ Time Frame: Up to 24 months ]
    Outcome will be assessed with mixed methods using qualitative & quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.

  6. Intervention adoption (program uptake) at community oncology sites [ Time Frame: Up to 24 months ]
    Outcome will be assessed with mixed methods using qualitative & quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.

  7. Intervention appropriateness (relevance) at community oncology sites [ Time Frame: Up to 24 months ]
    Outcome will be assessed with mixed methods using qualitative & quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.

  8. Intervention cost at community oncology sites [ Time Frame: Up to 24 months ]
    Outcome will be assessed with mixed methods using qualitative & quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.

  9. Treatment fidelity/adaptation at community oncology sites [ Time Frame: Up to 24 months ]
    Outcome will be assessed with mixed methods using qualitative & quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.

  10. Intervention penetration (reach) at community oncology sites [ Time Frame: Up to 24 months ]
    Outcome will be assessed with mixed methods using qualitative & quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.

  11. Intervention sustainability at community oncology sites [ Time Frame: Up to 24 months ]
    Outcome will be assessed with mixed methods using qualitative & quantitative data to be collected from patient, tobacco treatment counselor, NCORP oncology principal investigators (PIs) and provider clinicians/staff, and electronic health record (EHR) documentation. Will use descriptive statistics to summarize implementation outcome and conduct treatment group comparisons.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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, web and e-mail access.

    • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03808818


Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Elyse R Park, PhD, MPH    617-724-4738    epark@mgh.harvard.edu   
Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Elyse Park ECOG-ACRIN Cancer Research Group

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Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT03808818     History of Changes
Other Study ID Numbers: EAQ171CD
NCI-2018-02826 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
EAQ171CD ( Other Identifier: ECOG-ACRIN Cancer Research Group )
ECOG-ACRIN-EAQ171CD ( Other Identifier: DCP )
EAQ171CD ( Other Identifier: CTEP )
R01CA214427 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma in Situ
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action