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Study has been closed to accrual earlier than anticipated and will not resume.
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This project assesses the feasibility of utilizing the geriatric assessment as a tool to identify distressed older caregivers of older adults with cancer. The investigator will engage key stakeholders including older caregivers of older adults with cancer, experts in geriatric oncology and primary care physicians to develop and pilot a supportive care intervention to improve outcomes in older caregivers.
Older caregivers of older adults with cancer (described here-on as "older caregivers") are at high risk for increased burden and negative physical and psychological outcomes. Despite this, identification of older caregivers at risk for burden remains a challenge and evaluation of supportive care interventions and guidelines for this population remains limited. Health outcomes of older adults with cancer and their caregivers are inter-related and it is important to evaluate and support the health of both. The geriatric assessment (GA) is a valuable tool to evaluate health and age-related conditions (e.g., physical and cognitive function) of older adults with cancer and guide supportive care. Identifying older adults with age-related conditions can help to identify caregivers who are at increased risk for the negative impacts of caregiving. This project seeks to gather preliminary data on the health of older caregivers and to develop and pilot high priority supportive care interventions for this population. The investigator will examine the feasibility of utilizing the GA as a tool to identify distressed older caregivers. The investigator will engage key stakeholders including, older caregivers and older adults with cancer, experts in geriatric oncology and primary care physicians to develop and pilot a supportive care intervention to improve outcomes in older caregivers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Participants will receive a geriatric assessment which consists of validated questionnaires that are used to assess health status of older adults with cancer. Based on participant responses, tailored recommendations will be provided. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental (Delphi Surveys) | Other | The Delphi method, a process used to arrive at a group opinion or decision by surveying a panel of experts, will be used with experts in geriatric oncology to develop a supportive care management intervention for older caregivers of older adults with cancer. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who enroll and complete the GA | Percentage of participants who were approached, enrolled in the study and completed the GA will be determined. | 8 weeks per participant |
| Time for caregivers to complete the GA | Time to complete the GA per caregiver will be determined by summing the time to complete self-administered and clinic portions of GA. | 8 weeks per patient |
| Caregiver satisfaction with completing the GA | Caregivers will complete a questionnaire to assess satisfaction with completing the GA | 8 weeks per patient |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of caregiver supportive care recommendations that are implemented by patient/caregiver physicians | Caregivers will be surveyed to determined number and types of supportive care they received from their clinical providers compared to the supportive care recommendations that were provided to their clinical providers. | 4 weeks |
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Patient Inclusion Criteria
Patient Exclusion Criteria
Caregiver Inclusion Criteria
Caregiver Exclusion Criteria
• Patient and caregiver have not completed a GA
Stakeholder Inclusion Criteria
Stakeholder Exclusion Criteria • None
Geriatric Oncology Expert Inclusion Criteria
Geriatric Oncology Expert Exclusion Criteria
• None
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| Name | Affiliation | Role |
|---|---|---|
| Sindhuja Kadambi | Univ. of Rochester Wilmot Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
A complete and final study protocol will be made publicly available through the University of Rochester Cancer Center Community Oncology Research Program Research Base Protocol and Data Sharing Committee. The full protocol and data will be made publicly available no later than the publication date of the study findings from the final dataset. The protocol will include a detailed description of the study population, hypotheses tested, measurement and assessment information, data definitions and codes, and the analysis plan utilized. We will be collecting identifying information. The final dataset will be stripped of identifiers prior to release for sharing. Published papers will be made available in portable document format.
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The data will be available for 7 years from accrual of the first subject.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017144 | Focus Groups |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Experimental (Focus Groups) | Other | Focus group qualitative interviews will be conducted with key stakeholders consisting of older adults with cancer and their caregivers. |
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| Qualitative interviews | Other | Qualitative interviews will be conducted with older caregivers of older adults with cancer to inquire about their experience with caregiving and unmet supportive care needs. |
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |