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| ID | Type | Description | Link |
|---|---|---|---|
| WFBCCC 01220 | Other Identifier | Wake Forest Baptist Comprehensive Cancer Center | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this research is to assess the feasibility of administering a telephone-based intervention to treat depression and anxiety in Hispanic cancer survivors.
Primary Objectives
Exploratory Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telephone-Based Cognitive Behavioral Therapy | Other | Participants with moderate or severe anxiety and/or depressive symptoms will participate in the telephone-based intervention that consists of the CBT workbook (15 minutes daily to complete exercises), plus psychotherapy delivered by telephone with a licensed bilingual mental health provider (45-50 minute sessions weekly). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone interview | Behavioral | Interested participants will complete a telephone interview to determine eligibility for the study. If found to be eligible for the study, participants will be registered and set up a time to speak with an assigned study coach. |
| Measure | Description | Time Frame |
|---|---|---|
| Participation Rate - Percentage Who Agreed to Participate | To determine participation rate, investigators will track the total number of individuals approached, the number of individuals who met all eligibility criteria and percent who agree to participate. | 12 weeks after start of intervention |
| Accrual Rate | Accrual rates will be calculated by calculating the mean number of participants recruited per month. | 12 weeks after start of intervention |
| Retention Rate - Percentage of Completed Visits | Study retention will be estimated by the proportion of participants who complete the Week 13 visit. Drop-out is defined as 100% minus the dropout % | 13 weeks after the start of intervention |
| Adherence - Percentage of Completed Therapy Sessions | Intervention adherence will be estimated as the mean percentage of therapy or check-in sessions each participant completes. Participants must complete at least 9 of the 12 sessions (75%) to be considered adherent. | 12 weeks after start of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety Questionnaire - General Anxiety Disorder (GAD)-7 | The General Anxiety Disorder (GAD)-7 is a self-report measure of DSM-IV symptoms of general anxiety disorder. Participants rate 7 questions on a scale of 0 (not at all), 1 (several days), 2 (more than half the days) and 3 (nearly every day); one additional question assesses the interference of these symptoms with functioning. The first 7 questions are summed to create a total score. Scoring range is 0-21 with the higher score indicating a higher level of anxiety (scores 0 to less than or equal to 9 = no/mild anxiety; scores greater than or equal to 10 to less than or equal to 14 = moderate anxiety; scores greater than or equal to 15 to 21 = severe anxiety). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne C Danhauer, Ph.D | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Telephone-Based Cognitive Behavioral Therapy | Participants with moderate or severe anxiety and/or depressive symptoms will participate in the telephone-based intervention that consists of the CBT workbook (15 minutes daily to complete exercises), plus psychotherapy delivered by telephone with a licensed bilingual mental health provider (45-50 minute sessions weekly). Telephone interview: Interested participants will complete a telephone interview to determine eligibility for the study. If found to be eligible for the study, participants will be registered and set up a time to speak with an assigned study coach. Cognitive Behavioral Therapy: Participants will speak with their assigned coach over the phone for 12 weeks to discuss the cognitive behavioral therapy (CBT) study workbook and provide feedback. CBT is a type of treatment that teaches people different ways to handle anxiety and/or depressive symptoms, such as by relaxing the body, changing thoughts, and solving problems. Participants will receive a workbook focused on teaching these strategies. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Telephone-Based Cognitive Behavioral Therapy | Participants with moderate or severe anxiety and/or depressive symptoms will participate in the telephone-based intervention that consists of the CBT workbook (15 minutes daily to complete exercises), plus psychotherapy delivered by telephone with a licensed bilingual mental health provider (45-50 minute sessions weekly). Telephone interview: Interested participants will complete a telephone interview to determine eligibility for the study. If found to be eligible for the study, participants will be registered and set up a time to speak with an assigned study coach. Cognitive Behavioral Therapy: Participants will speak with their assigned coach over the phone for 12 weeks to discuss the cognitive behavioral therapy (CBT) study workbook and provide feedback. CBT is a type of treatment that teaches people different ways to handle anxiety and/or depressive symptoms, such as by relaxing the body, changing thoughts, and solving problems. Participants will receive a workbook focused on teaching these strategies. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participation Rate - Percentage Who Agreed to Participate | To determine participation rate, investigators will track the total number of individuals approached, the number of individuals who met all eligibility criteria and percent who agree to participate. | Posted | Number | percentage of participants | 12 weeks after start of intervention |
|
7 weeks after the start of study intervention and again at 12 weeks after the start of study intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Telephone-Based Cognitive Behavioral Therapy | Participants with moderate or severe anxiety and/or depressive symptoms will participate in the telephone-based intervention that consists of the CBT workbook (15 minutes daily to complete exercises), plus psychotherapy delivered by telephone with a licensed bilingual mental health provider (45-50 minute sessions weekly). Telephone interview: Interested participants will complete a telephone interview to determine eligibility for the study. If found to be eligible for the study, participants will be registered and set up a time to speak with an assigned study coach. Cognitive Behavioral Therapy: Participants will speak with their assigned coach over the phone for 12 weeks to discuss the cognitive behavioral therapy (CBT) study workbook and provide feedback. CBT is a type of treatment that teaches people different ways to handle anxiety and/or depressive symptoms, such as by relaxing the body, changing thoughts, and solving problems. Participants will receive a workbook focused on teaching these strategies. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Wake Forest Baptist Comprehensive Cancer Center | 336-716-9055 | megreen@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 15, 2021 | Jul 24, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 16, 2022 | Dec 27, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Cognitive Behavioral Therapy | Behavioral | Participants will speak with their assigned coach over the phone for 12 weeks to discuss the cognitive behavioral therapy (CBT) study workbook and provide feedback. CBT is a type of treatment that teaches people different ways to handle anxiety and/or depressive symptoms, such as by relaxing the body, changing thoughts, and solving problems. Participants will receive a workbook focused on teaching these strategies. |
|
| At baseline, 7 weeks and 13 weeks after start of intervention |
| Depressive Symptoms Questionnaire - Patient Health Questionnaire (PHQ)-9 | The Patient Health Questionnaire (PHQ)-9 is a self-report measure of DSM-IV symptoms of Major Depressive Disorder. Participants rate how often they have experienced nine symptoms over the past 2 weeks on a scale of 0 (not at all); 1 (several days), 2 (more than half the days) and 3 (nearly every day). Responses are summed, with higher scores indicating greater depressive symptomatology. Scoring scale = 0-27 (scores 0 to less than or equal to 7 = no/mild depressive symptoms; scores greater than or equal to 8 to less than or equal to 14 = moderate depressive symptoms; scores greater than or equal to 15 to 27 = severe depressive symptoms) | At baseline, 7 weeks and 13 weeks after start of intervention |
| Fear of Cancer Recurrence Inventory Questionnaire | The Fear of Cancer Recurrence Inventory (FCRI; severity subscale) will be used to measure self-reported fear of recurrence. This 9-item subscale measures the presence and severity of the intrusive thoughts or images associated with the fear of recurrence. Scoring scale ranges from 0 (not at all or never) to 4 (a great deal or all of the time). Score ranges from 0-36. The higher the score, the greater the participants' fear of recurrence. | At baseline and 13 weeks after start of intervention |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Accrual Rate | Accrual rates will be calculated by calculating the mean number of participants recruited per month. | Posted | Number | participants accrued per month | 12 weeks after start of intervention |
|
|
|
| Primary | Retention Rate - Percentage of Completed Visits | Study retention will be estimated by the proportion of participants who complete the Week 13 visit. Drop-out is defined as 100% minus the dropout % | Posted | Number | percentage of completion of Wk. 13 visit | 13 weeks after the start of intervention |
|
|
|
| Primary | Adherence - Percentage of Completed Therapy Sessions | Intervention adherence will be estimated as the mean percentage of therapy or check-in sessions each participant completes. Participants must complete at least 9 of the 12 sessions (75%) to be considered adherent. | Posted | Number | percentage to complete 9 or more session | 12 weeks after start of intervention |
|
|
|
| Secondary | Anxiety Questionnaire - General Anxiety Disorder (GAD)-7 | The General Anxiety Disorder (GAD)-7 is a self-report measure of DSM-IV symptoms of general anxiety disorder. Participants rate 7 questions on a scale of 0 (not at all), 1 (several days), 2 (more than half the days) and 3 (nearly every day); one additional question assesses the interference of these symptoms with functioning. The first 7 questions are summed to create a total score. Scoring range is 0-21 with the higher score indicating a higher level of anxiety (scores 0 to less than or equal to 9 = no/mild anxiety; scores greater than or equal to 10 to less than or equal to 14 = moderate anxiety; scores greater than or equal to 15 to 21 = severe anxiety). | Posted | Mean | Standard Error | score on a scale | At baseline, 7 weeks and 13 weeks after start of intervention |
|
|
|
| Secondary | Depressive Symptoms Questionnaire - Patient Health Questionnaire (PHQ)-9 | The Patient Health Questionnaire (PHQ)-9 is a self-report measure of DSM-IV symptoms of Major Depressive Disorder. Participants rate how often they have experienced nine symptoms over the past 2 weeks on a scale of 0 (not at all); 1 (several days), 2 (more than half the days) and 3 (nearly every day). Responses are summed, with higher scores indicating greater depressive symptomatology. Scoring scale = 0-27 (scores 0 to less than or equal to 7 = no/mild depressive symptoms; scores greater than or equal to 8 to less than or equal to 14 = moderate depressive symptoms; scores greater than or equal to 15 to 27 = severe depressive symptoms) | Posted | Mean | Standard Error | score on a scale | At baseline, 7 weeks and 13 weeks after start of intervention |
|
|
|
| Secondary | Fear of Cancer Recurrence Inventory Questionnaire | The Fear of Cancer Recurrence Inventory (FCRI; severity subscale) will be used to measure self-reported fear of recurrence. This 9-item subscale measures the presence and severity of the intrusive thoughts or images associated with the fear of recurrence. Scoring scale ranges from 0 (not at all or never) to 4 (a great deal or all of the time). Score ranges from 0-36. The higher the score, the greater the participants' fear of recurrence. | Posted | Mean | Standard Error | score on a scale | At baseline and 13 weeks after start of intervention |
|
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| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|---|---|
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| Title | Measurements |
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