- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05436327
Improving Communication for Cancer Treatment: Addressing Concerns of Older Cancer Patients and Caregivers
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- MD Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reach of Geriatric Assessment (GA) implementation in routine medical practice
Time Frame: monthly over 12 months of implementation, and 6 months after implementation
|
monthly over 12 months of implementation, and 6 months after implementation
|
|
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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:
Time Frame: monthly over 12 months of implementation, and 6 months after implementation
|
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.
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monthly over 12 months of implementation, and 6 months after implementation
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lisa Marie Lowenstein, PhD, MPH, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavior
- Neoplasms
- Communication
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Population Characteristics
- Health Status
- Demography
- Epidemiologic Measurements
- Geriatric Assessment
Other Study ID Numbers
- 2021-0881
- NCI-2022-05359 (Other Identifier: NCI-CTRP Clinical Trials Processing Registry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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