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

NCT05244915 | Terminated DMC

• 1 other identifier: UCCS21067
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Cancer; Geriatric Assessment

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Percentage of caregiver supportive care recommendations that are implemented by patient/caregiver physicians

  4 weeks

Study Arms (1)

Experimental

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.

Other: Experimental (Delphi Surveys); Other: Experimental (Focus Groups); Other: Qualitative interviews

Interventions

Experimental (Delphi Surveys) 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

Experimental (Focus Groups) OTHER

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

Experimental

Qualitative interviews 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.

Experimental

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Caregivers enrolled in phase I
• Patient and caregiver have completed a GA
• Patient and caregiver have not 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
• None

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Focus Groups

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sindhuja Kadambi

  Univ. of Rochester Wilmot Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Instructor - Department of Medicine , Hematology/Oncology (SMD)

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: February 17, 2022
• Study Start: December 7, 2021
• Primary Completion: August 11, 2023
• Study Completion: August 11, 2023
• Last Updated: January 6, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be available for 7 years from accrual of the first subject.

Locations

US (1)