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A Supportive Care Intervention for Older Caregivers of Older Adults with Advanced Cancer

Development and Feasibility of a Supportive Care Intervention for Older Caregivers of Older Adults with Advanced Cancer

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05244915
Enrollment
73
Registered
2022-02-17
Start date
2021-12-07
Completion date
2023-08-11
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Cancer, Geriatric Assessment

Brief 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.

Detailed 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.

Interventions

OTHERExperimental (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.

OTHERExperimental (Focus Groups)

Focus group qualitative interviews will be conducted with key stakeholders consisting of older adults with cancer and their caregivers.

OTHERQualitative 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.

Sponsors

University of Rochester
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of participants who enroll and complete the GA8 weeks per participantPercentage of participants who were approached, enrolled in the study and completed the GA will be determined.
Time for caregivers to complete the GA8 weeks per patientTime to complete the GA per caregiver will be determined by summing the time to complete self-administered and clinic portions of GA.
Caregiver satisfaction with completing the GA8 weeks per patientCaregivers will complete a questionnaire to assess satisfaction with completing the GA

Secondary

MeasureTime frameDescription
Percentage of caregiver supportive care recommendations that are implemented by patient/caregiver physicians4 weeksCaregivers 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026