Improving Communication for Cancer Treatment: Addressing Concerns of Older Cancer Patients and Caregivers

NCT ID: NCT05436327

Last Updated: 2025-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

479 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-06

Study Completion Date

2027-01-31

Brief Summary

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To improve patient-centered outcomes for older patients with cancer considering or receiving chemotherapy and their caregivers. To do this, the project team will (a) establish the effectiveness of GA on communication about age-related concerns, patient and caregiver satisfaction with communication about age-related concerns, quality of life, and patient-reported side effects of chemotherapy; (b) evaluate the success of the implementation strategies on the adoption, reach, and fidelity of implementing the GA in community oncology practices; and (c) identify the resources needed to implement GA and the GA-guided recommendations in community oncology practices for older patients considering or receiving chemotherapy.

Detailed Description

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Objectives:

* Establish the effectiveness of GA on patient and caregiver satisfaction and communication about age-related concerns for older patients receiving chemotherapy in community oncology practices.
* Evaluate the success of our implementation strategies on the reach, adoption, and fidelity of implementing the GA in community oncology practices.
* Identify the resources needed to implement GA and the GA-guided recommendations in community oncology practices for older patients receiving chemotherapy.

Conditions

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Cancer Aging Communication

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Geriatric Assessment (GA)

Clinical staff undergo training in GA and are provided with facilitation and support for one year as they implement GA among older adult patients (65+) considering chemotherapy and their care partners/caregivers.

Group Type OTHER

Geriatric Assessment

Intervention Type BEHAVIORAL

Clinical staff receive (a) training in GA and workflow management strategies (\<60 minutes) at baseline, (b) monthly facilitation and technical support calls (15-30 minutes) for 12 months, and (c) a group-based quarterly call for 12 months. For 12 months, clinical staff implement GA strategies during visits with older adult (65+) patients planning to receive new chemotherapy regimen and their care partners/caregivers.

Interventions

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Geriatric Assessment

Clinical staff receive (a) training in GA and workflow management strategies (\<60 minutes) at baseline, (b) monthly facilitation and technical support calls (15-30 minutes) for 12 months, and (c) a group-based quarterly call for 12 months. For 12 months, clinical staff implement GA strategies during visits with older adult (65+) patients planning to receive new chemotherapy regimen and their care partners/caregivers.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Aged 18 years or older
* A practicing clinician (e.g., oncologist, nurse practitioners, physician assistant, advanced practice nurse, registered nurse, medical assistant) or other practice staff (e.g., administrators and IT)
* Fluent in English (reading and speaking)
* Have access to computer, laptop, tablet, or smart phone


* Aged 65 and older
* Considering a new chemotherapy plan


* Aged 18 years and older
* Fluent in English (reading and speaking)
* Have access to computer, laptop, tablet, or smart phone

Exclusion Criteria

* Have plans to leave the practice in six months (e.g., retiring or changing organizations)
* Unable to provide consent

Patient Participants


• Have been diagnosed with a health condition that precludes their ability to participate in informed consent or in the intervention (e.g., dementia which limits decision-making capacity).

Care Partner/Caregiver Participants (Care partners can be any partner, spouse, family member, and/or friend that has been identified by the patient and/or clinical team that supports the patient through treatment.)


• Unable to provide consent

Inclusion of Special Populations:


Other special populations. This study will not include other special subject populations (students, Non-English-Speaking Populations, Minors, Human Fetuses; Neonates (infants under 30 days old), prisoners/detainees (wards)) because the purpose of the study is to understand the implementation of the GA in clinical oncology practices and its impact on patients 65+ with cancer and their care partners satisfaction with care, communication about their care, quality of life, and patient (65+) reported toxicities.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa Marie Lowenstein, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

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NCI-2022-05359

Identifier Type: OTHER

Identifier Source: secondary_id

2021-0881

Identifier Type: -

Identifier Source: org_study_id

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