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

NCT ID: NCT05244915

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-07
• Study Completion Date: 2023-08-11

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.

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Experimental (Delphi Surveys)

Intervention Type: 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.

Experimental (Focus Groups)

Intervention Type: OTHER

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

Qualitative interviews

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Experimental (Focus Groups)

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

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Caregivers enrolled in phase I
• Patient and caregiver have completed a GA

• 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

• Members of the Cancer and Aging Research Group
• Primary care physicians who care for older adults

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.

• Patient and caregiver have not completed a GA

• None

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Sindhuja Kadambi

Senior Instructor - Department of Medicine , Hematology/Oncology (SMD)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sindhuja Kadambi

Role: PRINCIPAL_INVESTIGATOR

Univ. of Rochester Wilmot Cancer Center

Locations

University of Rochester

Rochester, New York, United States

Countries

United States

Other Identifiers

UCCS21067

Identifier Type: -

Identifier Source: org_study_id