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| ID | Type | Description | Link |
|---|---|---|---|
| HM20026004 | Other Identifier | VCU |
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The purpose of this research study is to learn how best to incorporate tobacco cessation treatment into clinical care for cancer patients, survivors, and caregivers.
The goal of this study is to generate knowledge regarding the feasibility and acceptability of integrating tobacco cessation treatment into clinical care for cancer patients, survivors, and caregivers. The evidence base regarding tobacco treatment is solid: pharmacology (nicotine replacement therapy (and/or), bupropion, or varenicline) in combination with behavioral counseling yields the best results with respect to cessation rates. What remains unclear is how best to offer and implement this comprehensive treatment in the context of a cancer center-especially in a patient population facing social determinants of health that may not be in favor of tobacco cessation. Thus, in this study, the investigators are offering the "gold standard" tobacco treatment and assessing feasibility and acceptability of these procedures in order to inform future efforts to optimize treatment delivery for this unique population and setting. The intervention for this protocol was approved for standard of care use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Counseling for Tobacco Cessation | Experimental | Behavioral counseling for tobacco cessation consists of psychoeducation in combination with evidence-based behavior change techniques including stimulus control, self-monitoring, goal-setting, implementation planning, and problem-solving. Specific content topics include the harms of smoking/benefits of quitting, coping with cravings and withdrawal, setting a quit date, managing social influences, and relapse prevention. |
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| Observational Arm | No Intervention | Both the behavioral intervention and pharmacotherapy will be conducted as a routine clinical activities (treatment as usual)-not as research activities |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral counseling for tobacco cessation | Behavioral | Participants can choose to receive behavioral counseling in group v. individual format: Group Sessions: Participants will be offered the opportunity to attend 6 weekly 60-90 minute sessions Individual Sessions: Participants will be offered the opportunity to attend up to 12 30-45 minute sessions on a schedule mutually agreed upon between interventionist and participant |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Consent rate | The number of individuals who consented to participate compared to the number of individuals approached for study participation. | At enrollment visit |
| Feasibility: Barriers to participation | Reasons for refusal will be collected for eligible individuals who do not enroll in the study. | At recruitment visit |
| Acceptability: Participant satisfaction | Participant satisfaction ratings will be evaluated utilizing a questionnaire assessing participant satisfaction with the behavioral intervention (if applicable) and/or VCUHS pharmacotherapy management (if applicable) will be administered at each follow-up timepoint. | Week 6 |
| Acceptability: Participant satisfaction | Participant satisfaction ratings will be evaluated utilizing a questionnaire assessing participant satisfaction with the behavioral intervention (if applicable) and/or VCUHS pharmacotherapy management (if applicable) will be administered at each follow-up timepoint. | Week 12 |
| Acceptability: Participant satisfaction | Participant satisfaction ratings will be evaluated utilizing a questionnaire assessing participant satisfaction with the behavioral intervention (if applicable) and/or VCUHS pharmacotherapy management (if applicable) will be administered at each follow-up timepoint. | Week 24 |
| Acceptability: Behavioral counseling attendance | Participant attendance at scheduled group or 1:1 behavioral intervention sessions |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in tobacco use | Self-reported change in number of cigarettes smoked | Baseline to Week 12 |
| Change in tobacco use | Self-reported change in number of cigarettes smoked |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonice Wall | Contact | 804-827-2357 | walla2@vcu.edu | |
| Massey CPCTeam | Contact | 804-828-1965 | MasseyCPC@vcu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Livingstone Aduse-Poku, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Recruiting | Richmond | Virginia | 23298 | United States |
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| ID | Term |
|---|---|
| D020340 | Tobacco Use Cessation |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| 12 weeks |
| Acceptability: Nicotine replacement therapy adherence | Self-reported adherence to nicotine replacement therapy and/or varenicline or bupropion will be assessed at each follow-up timepoint. In addition, data re: tobacco cessation medication visits will be extracted from participants' EMR (e.g., number of visits, prescriptions written). | Week 6 |
| Acceptability: Nicotine replacement therapy adherence | Self-reported adherence to nicotine replacement therapy and/or varenicline or bupropion will be assessed at each follow-up timepoint. In addition, data re: tobacco cessation medication visits will be extracted from participants' EMR (e.g., number of visits, prescriptions written). | Week 12 |
| Acceptability: Nicotine replacement therapy adherence | Self-reported adherence to nicotine replacement therapy and/or varenicline or bupropion will be assessed at each follow-up timepoint. In addition, data re: tobacco cessation medication visits will be extracted from participants' EMR (e.g., number of visits, prescriptions written). | Week 24 |
| Baseline to Week 24 |