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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05244915
Other study ID # UCCS21067
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date December 7, 2021
Est. completion date August 11, 2023

Study information

Verified date February 2024
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Terminated
Enrollment 73
Est. completion date August 11, 2023
Est. primary completion date August 11, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Patient Inclusion Criteria - Patient and caregiver be aged 65 or older - Patient with a diagnosis of solid tumor malignancy or lymphoma, any stage - Patients who have initiated a new line of treatment (surgery, radiation therapy, chemotherapy, immunotherapy, or targeted therapy) OR are being considered for new line of treatment (surgery, radiation therapy, chemotherapy, immunotherapy, or targeted therapy). - Patients and caregivers must be able to provide informed consent, or if it is determined that they do not have decision-making capacity, a patient-designated health care proxy must sign consent per institutional University of Rochester and Research Subject Review Board policies on consent for incapacitated/decisionally impaired subjects. Patient Exclusion Criteria - Patient or caregiver is less than 65 years of age - Patient and caregivers who do not have decision-making capacity (decisionally or cognitively impaired) AND do NOT have a previously designated health care proxy available to sign consent. Caregiver Inclusion Criteria - Caregivers enrolled in phase I - Patient and caregiver have completed a GA Caregiver Exclusion Criteria • Patient and caregiver have not completed a GA Stakeholder Inclusion Criteria - Member of SCOREboard Community Advisory Board - Aged 65 years or older - Has been a family member, partner, friend or caregiver to an older adult with cancer Stakeholder Exclusion Criteria • None Geriatric Oncology Expert Inclusion Criteria - Members of the Cancer and Aging Research Group - Primary care physicians who care for older adults Geriatric Oncology Expert Exclusion Criteria • None

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Experimental (Delphi Surveys)
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.
Experimental (Focus Groups)
Focus group qualitative interviews will be conducted with key stakeholders consisting of older adults with cancer and their caregivers.
Qualitative interviews
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.

Locations

Country Name City State
United States University of Rochester Rochester New York

Sponsors (1)

Lead Sponsor Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Caregiver satisfaction with completing the GA Caregivers will complete a questionnaire to assess satisfaction with completing the GA 8 weeks per patient
Secondary 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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