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

NCT05436327 | Active Not Recruiting

• 2 other identifiers: 2021-0881NCI-2022-05359
• Study Type: interventional
• Target: 479
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Aging; Communication

Outcome Measures

Primary Outcomes (2)

• Reach of Geriatric Assessment (GA) implementation in routine medical practice

  monthly over 12 months of implementation, and 6 months after implementation

• Reach of Geriatric Assessment (GA) implementation in routine medical practice as measured by applying the reach formula (# people served divided by potential # of people) to the following four metrics:

  a) patients per month who received the Geriatric Assessment (GA), b) patients per month who received Geriatric Assessment (GA)-guided recommendations, c) total patients per month age 65+, d) total patients per month who were age 65+ and receiving new chemotherapy or deciding to start chemotherapy.

  monthly over 12 months of implementation, and 6 months after implementation

Study Arms (1)

Geriatric Assessment (GA)

OTHER

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.

Behavioral: Geriatric Assessment

Interventions

Geriatric Assessment 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.

Geriatric Assessment (GA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Have plans to leave the practice in six months (e.g., retiring or changing organizations)
• Unable to provide consent
• Patient Participants
• Aged 65 and older
• Considering a new chemotherapy plan
• 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.)
• Aged 18 years and older
• Fluent in English (reading and speaking)
• Have access to computer, laptop, tablet, or smart phone
• Unable to provide consent
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Neoplasms; Communication

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Lisa Marie Lowenstein, PhD, MPH

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 29, 2022
• Study Start: May 6, 2022
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)