Clinical trial NCT05244915: A Supportive Care Intervention for Older Caregivers of Older Adults with Advanced Cancer
Official title: Development and Feasibility of a Supportive Care Intervention for Older Caregivers of Older Adults with Advanced Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer
Keywords: Cancer
Geriatric Assessment
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 73
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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 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

Primary outcomes:
measure: Percentage of participants who enroll and complete the GA
timeFrame: 8 weeks per participant
measure: Time for caregivers to complete the GA
timeFrame: 8 weeks per patient
measure: Caregiver satisfaction with completing the GA
timeFrame: 8 weeks per patient
Secondary outcomes:
measure: Percentage of caregiver supportive care recommendations that are implemented by patient/caregiver physicians
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: Univ. of Rochester Wilmot Cancer Center
name: Sindhuja Kadambi
role: PRINCIPAL_INVESTIGATOR
References: