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| ID | Type | Description | Link |
|---|---|---|---|
| WFBCCC01520 | Other Identifier | Wake Forest Baptist Comprehensive Cancer Center | |
| P30CA012197 | U.S. NIH Grant/Contract | View source |
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Low accruals
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this research study is to test an online support group designed to help young adults who have had cancer treatment to manage their mood during a pandemic. Investigators hope to learn more about what effects a support group may have upon the health and well-being of young adults who have undergone cancer treatment by offering an online support group that teaches healthy coping skills in a practical and acceptable way. Investigators would also like to know if certain parts of the online material is more effective in helping subjects manage their mood.
Primary Objective: To improve self-efficacy for young adult cancer survivors navigating pandemic conditions.
Secondary Objective: To reduce depression and anxiety levels through meaning-making.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemental Group | Experimental | The virtual group will be conducted within a secure platform such as Microsoft WebEx. Assessments (pre-, post-, mid-way) will be distributed through REDCap, a secure virtual platform, as will session handouts and forms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemental Health Sessions, Support Groups and Questionnaires | Behavioral | Participants will complete initial online questionnaires lasting about 25-30 minutes as well as attend weekly support group meetings online. After 4 weeks, participants will complete seven online follow-up questionnaires that should take no longer than 30 minutes and again at the end of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-Efficacy in Pandemic Conditions | The improvement of self-efficacy for young adult cancer survivors navigating pandemic conditions will be assessed by comparing the change in the Cancer Behaviour Inventory-Brief (CBI-B) version (a 12-item validated questionnaire used widely as a measure of self-efficacy for coping with cancer) from baseline to Visit 8. To test the change over the 8 weeks, a paired t-test (using the baseline and Visit 8 scores within the same patient) will be used; the expected difference in the CBI-B between the two scores would be no change. Score range is 1 (not at all confident) to 9 (totally confident) (minimum score of 12, maximum score of 108). Sum the scores for the 12 items with higher scores indicating greater coping efficacy. | At baseline up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Depression and Anxiety Levels (CAS) | Three instruments will provide information on baseline, Visit 8, and change over time. 1) The Coronavirus Anxiety Scale (CAS) - 5-item mental health screener of dysfunctional anxiety associated with the coronavirus. Scoring is on a 5-point scale of 0 (not at all) to 4 (nearly every day). Minimum score (0): A score of 0 indicates that a person has not experienced any dysfunctional anxiety symptoms related to the coronavirus within the past two weeks. Maximum score (20): A score of 20 indicates the highest level of coronavirus-related anxiety, with the individual experiencing all five symptoms "nearly every day" over the past two weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katie Duckworth, Ph.D | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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The most common exclusion reasons were being from outside the health system, patients/missing information or deceased prior to medical record review and non-North Carolina resident status. 55 individuals met basic study criteria, 42% cited no specific reason for declining interest or participation. 14 individuals (25%) were both eligible and interested in participating. Two people consented but did not participate. Four individuals never formally consented.
Among the eligible recruitment pool, direct staff member referrals were most common. The final group was comprised primarily of referrals from existing databases.
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| ID | Title | Description |
|---|---|---|
| FG000 | TeleHealth Group | The virtual group will be conducted within a secure platform such as Microsoft WebEx. Assessments (pre-, post-, mid-way) will be distributed through REDCap, a secure virtual platform, as will session handouts and forms. Telemental Health Sessions, Support Groups and Questionnaires: Participants will complete initial online questionnaires lasting about 25-30 minutes as well as attend weekly support group meetings online. After 4 weeks, participants will complete seven online follow-up questionnaires that should take no longer than 30 minutes and again at the end of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TeleHealth Group | The virtual group will be conducted within a secure platform such as Microsoft WebEx. Assessments (pre-, post-, mid-way) will be distributed through REDCap, a secure virtual platform, as will session handouts and forms. Telemental Health Sessions, Support Groups and Questionnaires: Participants will complete initial online questionnaires lasting about 25-30 minutes as well as attend weekly support group meetings online. After 4 weeks, participants will complete seven online follow-up questionnaires that should take no longer than 30 minutes and again at the end of the study. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Change in Self-Efficacy in Pandemic Conditions | The improvement of self-efficacy for young adult cancer survivors navigating pandemic conditions will be assessed by comparing the change in the Cancer Behaviour Inventory-Brief (CBI-B) version (a 12-item validated questionnaire used widely as a measure of self-efficacy for coping with cancer) from baseline to Visit 8. To test the change over the 8 weeks, a paired t-test (using the baseline and Visit 8 scores within the same patient) will be used; the expected difference in the CBI-B between the two scores would be no change. Score range is 1 (not at all confident) to 9 (totally confident) (minimum score of 12, maximum score of 108). Sum the scores for the 12 items with higher scores indicating greater coping efficacy. | Seven participants completed instruments at Baseline, 6 at 4 weeks and 8 weeks. | Posted | Mean | 95% Confidence Interval | score on a scale | At baseline up to 8 weeks |
|
Deaths and adverse events were not collected.
Due to the nature and scope of this study, investigators did not anticipate any adverse events would be reported by participants.
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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 | TeleHealth Group | The virtual group will be conducted within a secure platform such as Microsoft WebEx. Assessments (pre-, post-, mid-way) will be distributed through REDCap, a secure virtual platform, as will session handouts and forms. Telemental Health Sessions, Support Groups and Questionnaires: Participants will complete initial online questionnaires lasting about 25-30 minutes as well as attend weekly support group meetings online. After 4 weeks, participants will complete seven online follow-up questionnaires that should take no longer than 30 minutes and again at the end of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Wake Forest Baptist Comprehensive Cancer Center | 3367135440 | Katie.Duckworth@advocatehealth.org |
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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 | May 14, 2021 | Aug 20, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 20, 2021 | Jan 30, 2025 | 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 |
|---|---|
| D012657 | Self-Help Groups |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
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| At baseline up to 8 weeks |
| Changes in Depression and Anxiety Levels (PIL) | Three instruments will provide information on baseline, Visit 8, and change over time. 2) The Purpose in Life Test (PIL) - 20-item, 7-point Likert scale designed to measure the extent to which a respondent perceives a general sense of meaning and purpose in life using varying scale labels, scores are aggregated with a minimum score of 20 (lowest purpose) and a maximum score of 140 (highest purpose). | At baseline up to 8 weeks |
| Changes in Depression and Anxiety Levels (MAC) | Three instruments will provide information on baseline, Visit 8, and change over time. 3) Mini-Mental Adjustments to Cancer - 29-item, 4-point Likert scale (maximum possible score of 116 and minimum possible score of 29) for rapid assessment of present coping style from 1 (Definitely Does Not Apply to Me) to 4 (Definitely Apply to Me), higher score represents higher endorsement of the adjustment response. (4). Five subscales include: Helpless-Hopeless (score range 8-32), Anxious Preoccupation (score range 8-32), Cognitive Avoidance (score range 4-16), Fighting Spirit (score range 4-16) and Fatalism (score range 5-20). | At baseline up to 8 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Work/Study Location | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
The virtual group will be conducted within a secure platform such as Microsoft WebEx. Assessments (pre-, post-, mid-way) will be distributed through REDCap, a secure virtual platform, as will session handouts and forms. Telemental Health Sessions, Support Groups and Questionnaires: Participants will complete initial online questionnaires lasting about 25-30 minutes as well as attend weekly support group meetings online. After 4 weeks, participants will complete seven online follow-up questionnaires that should take no longer than 30 minutes and again at the end of the study. |
|
|
|
| Secondary | Changes in Depression and Anxiety Levels (CAS) | Three instruments will provide information on baseline, Visit 8, and change over time. 1) The Coronavirus Anxiety Scale (CAS) - 5-item mental health screener of dysfunctional anxiety associated with the coronavirus. Scoring is on a 5-point scale of 0 (not at all) to 4 (nearly every day). Minimum score (0): A score of 0 indicates that a person has not experienced any dysfunctional anxiety symptoms related to the coronavirus within the past two weeks. Maximum score (20): A score of 20 indicates the highest level of coronavirus-related anxiety, with the individual experiencing all five symptoms "nearly every day" over the past two weeks. | Seven participants completed instruments at Baseline, 6 at 4 weeks and 8 weeks. | Posted | Mean | 95% Confidence Interval | score on a scale | At baseline up to 8 weeks |
|
|
|
|
| Secondary | Changes in Depression and Anxiety Levels (PIL) | Three instruments will provide information on baseline, Visit 8, and change over time. 2) The Purpose in Life Test (PIL) - 20-item, 7-point Likert scale designed to measure the extent to which a respondent perceives a general sense of meaning and purpose in life using varying scale labels, scores are aggregated with a minimum score of 20 (lowest purpose) and a maximum score of 140 (highest purpose). | Seven participants completed instruments at Baseline, 6 at 4 weeks and 8 weeks. | Posted | Mean | 95% Confidence Interval | score on a scale | At baseline up to 8 weeks |
|
|
|
|
| Secondary | Changes in Depression and Anxiety Levels (MAC) | Three instruments will provide information on baseline, Visit 8, and change over time. 3) Mini-Mental Adjustments to Cancer - 29-item, 4-point Likert scale (maximum possible score of 116 and minimum possible score of 29) for rapid assessment of present coping style from 1 (Definitely Does Not Apply to Me) to 4 (Definitely Apply to Me), higher score represents higher endorsement of the adjustment response. (4). Five subscales include: Helpless-Hopeless (score range 8-32), Anxious Preoccupation (score range 8-32), Cognitive Avoidance (score range 4-16), Fighting Spirit (score range 4-16) and Fatalism (score range 5-20). | Seven participants completed instruments at Baseline, 6 at 4 weeks and 8 weeks. | Posted | Mean | 95% Confidence Interval | score on a scale | At baseline up to 8 weeks |
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|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| 8 weeks |
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| 8 weeks |
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| Baseline-Fatalism |
|
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| Baseline- Fighting spirit |
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| Baseline- Helplessness/hopelessness |
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| 4 weeks - Anxious preoccupation |
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| 4 weeks - Cognitive avoidance |
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| 4 weeks - Fatalism |
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| 4 weeks -Fighting spirit |
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| 4 weeks -Helplessness/hopelessness |
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| 8 weeks- Anxious preoccupation |
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| 8 weeks- Cognitive avoidance |
|
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| 8 weeks- Fatalism |
|
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| 8 weeks- Fighting spirit |
|
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| 8 weeks- Helplessness/hopelessness |
|
|
| 0.0772 |
| Mean Difference (Final Values) |
| -5.3 |
| Standard Deviation |
| 5.9 |
| 2-Sided |
| 95 |
| -11.5 |
| 0.8 |
| Superiority |
Paired t-test of The Mini-Mental Adjustment to Cancer Cognitive avoidance Subscale. Statistical significance determine with alpha of 0.05. |
| t-test, 2 sided | 0.2452 | Mean Difference (Final Values) | 3.0 | Standard Deviation | 5.6 | 2-Sided | 95 | -2.9 | 8.9 | Superiority | Paired t-test of The Mini-Mental Adjustment to Cancer Fatalism Subscale. Statistical significance determine with alpha of 0.05. |
| t-test, 2 sided | 0.6099 | Mean Difference (Final Values) | -1.8 | Standard Deviation | 8.3 | 2-Sided | 95 | -10.5 | 6.8 | Superiority | Paired t-test of The Mini-Mental Adjustment to Cancer Fighting spirit Subscale. Statistical significance determine with alpha of 0.05. |
| t-test, 2 sided | 0.0913 | Mean Difference (Final Values) | -3.0 | Standard Deviation | 3.5 | 2-Sided | 95 | -6.7 | 0.7 | Superiority | Paired t-test of The Mini-Mental Adjustment to Cancer Helplessness/hopelessness Subscale. Statistical significance determine with alpha of 0.05. |