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

January 3, 2025 updated by: Sindhuja Kadambi, University of Rochester

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
73

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)
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.
Other: Experimental (Focus Groups)
Focus group qualitative interviews will be conducted with key stakeholders consisting of older adults with cancer and their caregivers.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of participants who enroll and complete the GA
Time Frame: 8 weeks per participant
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 Frame: 8 weeks per patient
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
Time Frame: 8 weeks per patient
Caregivers will complete a questionnaire to assess satisfaction with completing the GA
8 weeks per patient

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of caregiver supportive care recommendations that are implemented by patient/caregiver physicians
Time Frame: 4 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Rochester

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sindhuja Kadambi, Univ. of Rochester Wilmot Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 7, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 11, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 11, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UCCS21067

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A complete and final study protocol will be made publicly available through the University of Rochester Cancer Center Community Oncology Research Program Research Base Protocol and Data Sharing Committee. The full protocol and data will be made publicly available no later than the publication date of the study findings from the final dataset. The protocol will include a detailed description of the study population, hypotheses tested, measurement and assessment information, data definitions and codes, and the analysis plan utilized. We will be collecting identifying information. The final dataset will be stripped of identifiers prior to release for sharing. Published papers will be made available in portable document format.

IPD Sharing Time Frame

The data will be available for 7 years from accrual of the first subject.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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