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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA012197 | U.S. NIH Grant/Contract | View source | |
| ONC-CCS-2408 | Other Identifier | Atrium Health Wake Forest Baptist Comprehensive Cancer Center |
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| Name | Class |
|---|---|
| Atrium Health Wake Forest Baptist | OTHER |
| National Cancer Institute (NCI) | NIH |
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The purpose of this research study is to learn more about how Dialectical Behavior Therapy - Skills Training can help patients with cancer who smoke cigarettes cut down on or stop their smoking.
This is a study that aims to evaluate recruitment rates, feasibility, acceptability, and fidelity of Dialectical Behavior Therapy - Skills Training (DBT-ST) brief intervention.
Study population will include participants who smoke and are undergoing treatment with curative intent for their cancer or are in remission.
The study will include eight 60 minute sessions of DBT-ST and measurements of psychological states and smoking habits by interventionists. At follow-up participants will complete a survey on their intervention experience and ongoing use of DBT-ST. Interventionists will also complete a survey following each session to record time and materials use for future cost-effectiveness analysis.
At follow-up, participants and interventionists will engage in a one-hour qualitative interview with a study team member.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with cancer who smoke | Experimental | Participants who smoke and are undergoing treatment with a curative intent for cancer or are in remission from cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dialectical Behavior Therapy -Skill Training brief intervention | Behavioral | A behavioral counseling approach for enhancing skills in emotion regulation, distress tolerance, and mindfulness |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rates | Ratio of patients enrolled in study to patients responding to advertisement or referred by providers, and ratio of patients enrolled to patients screened and potentially eligible for the study. | Measured from the date the first patient responds to advertisement or is referred to the study by providers until the date the last patient group begins the first session of the intervention, assessed up to 100 weeks. |
| Feasibility of the DBT-ST brief intervention for cigarette smoking by patients with cancer | Rate of completion of the eight proposed sessions by participants | Measured from the date the first patient group begins the first session of the intervention until the date the last patient group completes the eighth session of the intervention, assessed up to 100 weeks. |
| Acceptability of the DBT-ST brief intervention for cigarette smoking by patients with cancer | Quantitative (Likert scale) questions to assess patient experience of intervention | For each patient group, measured at weeks 1 through 8 of the intervention and at 1 month follow-up, assessed up to 100 weeks. |
| Fidelity of the DBT-ST brief intervention for cigarette smoking by patients with cancer | Interventionist adherence to intervention manual will be assessed by having an independent reviewer select 50% of the audiotaped group sessions (the total depends on the number of groups) and complete a checklist of 25 intervention items (yes/no) to see whether the interventionist performed the item | Measured beginning 1 month after the date of week 8 of the final patient group participating in the intervention, assessed up to 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer Patient Tobacco Use Questionnaire (C-TUQ) | Changes in tobacco use, specifically number of days engaging in cigarette smoking (frequency) and number of cigarettes smoked per day (daily average) will be measured using the Cancer Patient Tobacco Use Questionnaire (C-TUQ) a 22-item self-report survey used to gather information about tobacco use by patients with cancer and cancer survivors. | Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported cost for interventionist and patient time and expenses | Self-reported cost for interventionist and patient time and expenses will be collected using an interventionist questionnaire | Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks. |
| Costs of nicotine replacement therapy |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James Morgan | Contact | 336-712-4491 | jwmorgan@wakehealth.edu |
| Name | Affiliation | Role |
|---|---|---|
| Marcia McCall, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Levine Cancer | Recruiting | Charlotte | North Carolina | 28204 | United States |
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| Difficulties in Emotion Regulation Scale-36 (DERS-36) | The Difficulties in Emotion Regulation Scale (DERS) is a 36-item self-report Likert scale used to assess emotional regulation presented as a total score and 6 sub-scores including nonacceptance of emotional responses, difficulty engaging in goal-directed behavior, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity | Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks. |
| Depression Anxiety Stress Scales-21 (DASS-21) | The DASS-21 is a 21-item self-report instrument designed to measure the three related negative emotional states of depression, anxiety, and tension/stress. | Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks. |
| Distress Tolerance Scale (DTS) | Distress tolerance will be measured using the 15-item Distress Tolerance Scale (DTS). The DTS uses a 5-point Likert scale for participants to record responses to items (1 = 'Strongly Agree' to 5 = 'Strongly Disagree'). The total DTS score is calculated by adding the scores of all 15 items together after reverse-coding item 6 (score range 0-75) | Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks. |
| Mindfulness Attention Awareness Scale (MAAS) | Mindfulness will be measured using the Mindfulness Attention Awareness Scale (MAAS), a 15-item self-report instrument designed to assess a core characteristic of dispositional mindfulness, namely, open or receptive awareness of and attention to what is taking place in the present. The MAAS score is the mean of 15 Likert-scale items from 1-6 (score range 1-6) | Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks. |
| Mental Adjustment to Cancer (MAC) Scale - Mini | The MAC-Mini is a 29-item self-rating scale to assess psychological dimensions of in cancer patients of helplessness/hopelessness, anxious preoccupation, fatalism, avoidance, and fighting spirit in their adjustment to the diagnosis and treatment of cancer. Higher scores reflect lower levels of adjustment for all subscales except fighting spirit, with a higher score indicating higher adjustment | Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks. |
| DBT Ways of Coping Checklist (DBT-WCCL) | The DBT-WCCL is a 59-item self-report Likert scale, with one part assessing coping via DBT skills, the DBT Skills Subscale (DSS), and one part assessing coping via dysfunctional means, the Dysfunctional Coping Subscale (DCS).44 Skills use are measured on a scale from 0 (never used) to 3 (regularly used). Higher scores indicate more frequent use of DBT skills and functional coping behaviors. | Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks. |
| Serious quit attempts | The period of intentional abstinence from smoking typically lasting at least 24 hours, to be collected by self-report using a single item Serious Quit Attempt questionnaire | Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks. |
Costs of nicotine replacement therapy will be captured using a single item added to the Cancer Patient Tobacco Use Questionnaire (item 15a) |
| Measured at baseline, week 5, week 8, and at 1 month follow-up, assessed up to 100 weeks. |
| Time between initial cancer diagnosis and administration of the DBT-ST intervention | The impact on smoking cessation or reduction of the length of time between initial cancer diagnosis and administration of the DBT-ST intervention will be measured using the initial diagnosis date of any cancer per the patient's electronic health record and the Cancer Patient Tobacco Use Questionnaire | Measured from the date of initial cancer diagnosis until week 1 of the patient's participation in the intervention, assessed up to 100 weeks. |
| Group Size | The impact of group size on outcomes will be measured using the number of persons in each group, provided group size varies | Measured beginning 1 month after the date of week 8 of the final patient group participating in the intervention, assessed up to 6 months. |
| Atrium Health Wake Forest Baptist Comprehensive Cancer Center | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
|
| ID | Term |
|---|---|
| D012907 | Smoking |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001519 | Behavior |
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