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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Development and Feasibility of a Supportive Care Intervention for Older Caregivers of Older Adults With Advanced Cancer

Conditions
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Cancer

Intervention / Treatment
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* Other: Experimental (Delphi Surveys)
* Other: Experimental (Focus Groups)
* Other: Qualitative interviews


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria for Patients Age 65+ years Patient with a diagnosis of solid tumor malignancy or lymphoma Patients starting a new line of treatment Able to provide informed consent or, if the physician deems the participants do not have decision-making capacity, a patient-designated health care proxy (that was pre-existing prior to the patient losing decision-making capacity must sign consent per institutional (University of Rochester and Research Subject review Board) policies on consent for incapacitated/decisionally impaired subjects. Inclusion criteria for caregivers: Aged 65+ years Selected by patient when asked if there is a family member, partner, friend, or caregiver (age 65 or older) with whom you discuss or who can be helpful in health-related matters? Able to provide informed consent or, if the physician deems the participants do not have decision-making capacity, a patient-designated health care proxy (that was pre-existing prior to the patient losing decision-making capacity must sign consent per institutional (University of Rochester and Research Subject review Board) policies on consent for incapacitated/decisionally impaired subjects. Inclusion criteria for geriatric oncology experts: -- Oncologists, APPs, nurses, therapists who have expertise in caring for older adults with cancer Inclusion criteria for additional stakeholders: Patients aged 65+ with current or prior history of cancer and caregivers of patients aged 65+ Exclusion Criteria: -Patient and caregivers who do not have decision-making capacity (decisionally or cognitively impaired) AND do NOT have a previously designated health care proxy (established prior to their cognitive impairment) available to sign consent.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>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)<br>* 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.<br>Other: Experimental (Focus Groups)<br>* Focus group qualitative interviews will be conducted with key stakeholders consisting of older adults with cancer and their caregivers.<br>Other: Qualitative interviews<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Geriatric Assessment