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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG077053 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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To gather key stakeholder input for feedback on the adaption of the COACH GA intervention (i.e., develop COACH-Cog) to enhance triadic communication among oncologists, care partners and patients with ADRD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical Oncologists and Clinicians | Individuals practicing as medical oncologists or with expertise in medical oncology. Clinicians with expertise in cognitive impairment and dementia | ||
| Older patients with cancer | Older patients with cancer or older survivors of patients with cancer | ||
| Caregivers of patients with dementia or cognitive impairment | Caregivers of patients with dementia or cognitive impairment |
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| Measure | Description | Time Frame |
|---|---|---|
| Qualitative Analysis of Focus Group Audio-recording Transcripts. Open Coding Using Content Analysis Framework Will be Utilized to Assess Positive Regard for the Intervention and Potential Intervention Adaptations. | Qualitative data gathered from participants during focus group participation. Focus groups will be audio-recorded and transcribed. Transcribed audio-recordings will be qualitatively analyzed for positive regard for the intervention and opportunities and recommendations for further intervention adaptation. Open coding using content analysis framework will be utilized for qualitative analysis. | Through study completion approximately 3 months |
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Inclusion/Exclusion Criteria:
The inclusion and exclusion criteria for participants are that they must be able to consent for themselves and must speak English.
For the medical oncologist focus group, participants must be a medical oncologist.
For the clinicians with expertise in cognitive impairment and dementia focus group, participants must be a clinician that treats patients with cognitive impairment and dementia.
For the older patients with cancer focus group, participants must be older than 65 years of age and have or had cancer.
For the caregivers of patients with dementia focus group, participants must be caregivers of patients with dementia or cognitive impairment.
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Focus groups will be conducted with the following stakeholders:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Wilmot Cancer Institute | Rochester | New York | 14620 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Medical Oncologists and Clincians | Individuals practicing as medical oncologists or with expertise in medical oncology. Clinicians with expertise in cognitive impairment and dementia. |
| FG001 | Older Patients With Cancer | Older patients with cancer or older survivors of patients with cancer |
| FG002 | Caregivers of Patients With Dementia or Cognitive Impairment | Caregivers of patients with dementia or cognitive impairment |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Medical Oncologists and Clinicians | Individuals practicing as medical oncologists or with expertise in medical oncology. Clinicians with expertise in cognitive impairment and dementia. |
| BG001 | Older Patients With Cancer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Qualitative Analysis of Focus Group Audio-recording Transcripts. Open Coding Using Content Analysis Framework Will be Utilized to Assess Positive Regard for the Intervention and Potential Intervention Adaptations. | Qualitative data gathered from participants during focus group participation. Focus groups will be audio-recorded and transcribed. Transcribed audio-recordings will be qualitatively analyzed for positive regard for the intervention and opportunities and recommendations for further intervention adaptation. Open coding using content analysis framework will be utilized for qualitative analysis. | Posted | Count of Participants | Participants | Through study completion approximately 3 months |
|
We collected data on any adverse events that occur during the focus group that are attributable to the focus group which was 1 week in duration.
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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 | Medical Oncologists and Clinicians | Individuals practicing as medical oncologists or with expertise in medical oncology. Clinicians with expertise in cognitive impairment and dementia. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Allison Magnuson | University of Rochester | 585-602-5085 | allison_magnuson@urmc.rochester.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 | Aug 22, 2023 | Sep 11, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 26, 2023 | Sep 11, 2024 | ICF_001.pdf |
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Older patients with cancer or older survivors of patients with cancer
| BG002 | Caregivers of Patients With Dementia or Cognitive Impairment | Caregivers of patients with dementia or cognitive impairment |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Older Patients With Cancer | Older patients with cancer or older survivors of patients with cancer |
| OG002 | Caregivers of Patients With Dementia or Cognitive Impairment | Caregivers of patients with dementia or cognitive impairment |
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Older Patients With Cancer | Older patients with cancer or older survivors of patients with cancer | 0 | 4 | 0 | 4 | 0 | 4 |
| EG002 | Caregivers of Patients With Dementia or Cognitive Impairment | Caregivers of patients with dementia or cognitive impairment | 0 | 9 | 0 | 9 | 0 | 9 |
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