Clincosm LogoSign in Get a demo

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

Sponsor
ECOG-ACRIN Cancer Research Group (Other)
Overall Status
Recruiting
CT.gov ID
NCT03808818
Collaborator
National Cancer Institute (NCI) (NIH)
418
Enrollment
42
Locations
2
Arms
58.2
Anticipated Duration (Months)
10
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • 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:
  1. 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:

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

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

  3. 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.

  4. 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:

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

  2. 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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Apr 11, 2019
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 15, 2024

Arms and Interventions

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 Names:
  • 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 Names:
  • Quality of Life Assessment

    • Other: Survey Administration
    Ancillary studies

    Other: Tobacco Cessation Counseling
    Receive virtual tobacco cessation counseling

    Outcome Measures

    Primary Outcome Measures

    1. 7-day point-prevalence tobacco abstinence by saliva cotinine or expired air carbon monoxide (CO) [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 [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 [At 3 months]

      Chi-square tests will be used to compare the outcomes between treatment groups.

    3. Self-reported 7-day point prevalence abstinence [At 6 months]

      Chi-square tests will be used to compare the outcomes between treatment groups.

    4. Self-reported continuous tobacco abstinence [At 6 months]

      Chi-square tests will be used to compare the outcomes between treatment groups.

    5. Sustained tobacco abstinence at 6 months [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alaska Women's Cancer Care Anchorage Alaska United States 99508
    2 Katmai Oncology Group Anchorage Alaska United States 99508
    3 Northside Hospital Atlanta Georgia United States 30342
    4 Augusta University Medical Center Augusta Georgia United States 30912
    5 Carle on Vermilion Danville Illinois United States 61832
    6 Good Samaritan Regional Health Center Mount Vernon Illinois United States 62864
    7 Carle Cancer Center Urbana Illinois United States 61801
    8 Physicians' Clinic of Iowa PC Cedar Rapids Iowa United States 52402
    9 Iowa Methodist Medical Center Des Moines Iowa United States 50309
    10 Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa United States 50309
    11 Unity Hospital Fridley Minnesota United States 55432
    12 Baptist Memorial Hospital and Cancer Center-Desoto Southhaven Mississippi United States 38671
    13 Freeman Health System Joplin Missouri United States 64804
    14 Heartland Regional Medical Center Saint Joseph Missouri United States 64506
    15 CoxHealth South Hospital Springfield Missouri United States 65807
    16 Montefiore Medical Center - Moses Campus Bronx New York United States 10467
    17 CaroMont Regional Medical Center Gastonia North Carolina United States 28054
    18 Margaret R Pardee Memorial Hospital Hendersonville North Carolina United States 28791
    19 Strecker Cancer Center-Belpre Belpre Ohio United States 45714
    20 Marietta Memorial Hospital Marietta Ohio United States 45750
    21 OhioHealth Marion General Hospital Marion Ohio United States 43302
    22 Southern Ohio Medical Center Portsmouth Ohio United States 45662
    23 Prisma Health Cancer Institute - Easley Easley South Carolina United States 29640
    24 Prisma Health Cancer Institute - Butternut Greenville South Carolina United States 29605
    25 Prisma Health Cancer Institute - Faris Greenville South Carolina United States 29605
    26 Prisma Health Cancer Institute - Eastside Greenville South Carolina United States 29615
    27 Prisma Health Cancer Institute - Greer Greer South Carolina United States 29650
    28 Prisma Health Cancer Institute - Seneca Seneca South Carolina United States 29672
    29 Prisma Health Cancer Institute - Spartanburg Spartanburg South Carolina United States 29307
    30 Baptist Memorial Hospital and Cancer Center-Memphis Memphis Tennessee United States 38120
    31 Baptist Memorial Hospital for Women Memphis Tennessee United States 38120
    32 MultiCare Auburn Medical Center Auburn Washington United States 98001
    33 MultiCare Gig Harbor Medical Park Gig Harbor Washington United States 98335
    34 MultiCare Good Samaritan Hospital Puyallup Washington United States 98372
    35 MultiCare Tacoma General Hospital Tacoma Washington United States 98405
    36 ThedaCare Regional Cancer Center Appleton Wisconsin United States 54911
    37 Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin United States 54301
    38 Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin United States 54303
    39 Aurora BayCare Medical Center Green Bay Wisconsin United States 54311
    40 Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls Wisconsin United States 54154
    41 HSHS Saint Nicholas Hospital Sheboygan Wisconsin United States 53081
    42 Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay Wisconsin United States 54235-1495

    Sponsors and Collaborators

    • ECOG-ACRIN Cancer Research Group
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Elyse Park, ECOG-ACRIN Cancer Research Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ECOG-ACRIN Cancer Research Group
    ClinicalTrials.gov Identifier:
    NCT03808818
    Other Study ID Numbers:
    • EAQ171CD
    • NCI-2018-02826
    • EAQ171CD
    • ECOG-ACRIN-EAQ171CD
    • EAQ171CD
    • R01CA214427
    First Posted:
    Jan 18, 2019
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms
    Carcinoma in Situ
    Recurrence
    Nicotine

    Study Results

    No Results Posted as of Aug 12, 2022