Clinical trial NCT05436327: Improving Communication for Cancer Treatment: Addressing Concerns of Older Cancer Patients and Caregivers
Official title: Improving Communication for Cancer Treatment: Addressing Concerns of Older Cancer Patients and Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Aging
Communication
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2022-06-29
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

Eligibility criteria: Practice Staff Participants

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

Exclusion Criteria:

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

Patient Participants

Inclusion Criteria:

* Aged 65 and older
* Considering a new chemotherapy plan

Exclusion Criteria:

• 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.)

Inclusion Criteria:

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

Exclusion Criteria:

• Unable to provide consent

Inclusion of Special Populations:

Employees. The rationale for including employees is to gain a better understanding of how we can improve cancer care for older patients with cancer receiving chemotherapy. It is possible that some employees may be pregnant women or military personnel. We intend to include these individuals as long as they meet the inclusion and exclusion criteria because this is a clinical improvement project to promote the implementation of the GA in routine clinical practice and should have external validity. These individuals would not be excluded in other clinical improvement projects outside of a research study.

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.

Primary outcomes:
measure: Reach of Geriatric Assessment (GA) implementation in routine medical practice
timeFrame: monthly over 12 months of implementation, and 6 months after implementation
measure: 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:
timeFrame: monthly over 12 months of implementation, and 6 months after implementation
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lisa Marie Lowenstein, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: