An interventional study of Experimental (Delphi Surveys) and Experimental (Focus Groups) in Cancer, sponsored by University of Rochester. Terminated at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-01-06.
Sponsored by University of Rochester · Not applicable, Interventional, and Supportive care
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.
University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patient Inclusion Criteria
Patient Exclusion Criteria
Caregiver Inclusion Criteria
Caregiver Exclusion Criteria
Stakeholder Inclusion Criteria
Stakeholder Exclusion Criteria • None
Geriatric Oncology Expert Inclusion Criteria
Geriatric Oncology Expert Exclusion Criteria
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.
Other: Experimental (Delphi Surveys) · Other: Experimental (Focus Groups) · Other: Qualitative interviews
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.
Focus group qualitative interviews will be conducted with key stakeholders consisting of older adults with cancer and their caregivers.
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.
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.
Time frame: 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.
Time frame: 8 weeks per patient
Caregiver satisfaction with completing the GA
Caregivers will complete a questionnaire to assess satisfaction with completing the GA
Time frame: 8 weeks per patient
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.
Time frame: 4 weeks
Plan to share: Yes — 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.
No publications or documents are linked to this record.
This study is terminated, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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