Clinical trial NCT05374304: Decision Making for Older Adults With Cancer
Official title: Improving Decision Making for Older Adults With Cancer: A Feasibility Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Geriatric Oncology
Decision Making
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Mount Zion Health Fund
First posted: 2022-05-16
Enrollment: 65
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled trial (CRT)
Primary purpose: OTHER

Brief summary: This is a minimal risk, pilot cluster randomized controlled trial (CRT) to determine the feasibility and acceptability of training medical oncologists to use the Best Case/Worst Case-Geriatric Oncology (BC/WC-GeriOnc) communication tool in clinical practice with older adults with cancer.

Detailed description: Primary Objective:

I. To assess the feasibility of study procedures and using the BC/WC-GeriOnc communication tool in medical oncology with older adults with cancer.

Secondary Objectives

I. To evaluate the acceptability and appropriateness of using the BC/WC-GeriOnc communication tool.

II. To evaluate BC/WC-GeriOnc intervention fidelity and adherence by oncologists .

Exploratory Objectives:

I. To assess shared decision making and qualitatively compare cancer decision-making discussions led by oncologists randomized to the BC/WC-GeriOnc intervention versus control.

II. To determine the variability in physician-patient communication and decision-making outcomes in the intervention and control groups III. To characterize cancer care decisions and health care utilization in the intervention and control groups.

During the lead-in phase, 2 medical oncologists and 4 participants will be enrolled. During the CRT, 7 medical oncologists, 49 patients, and up to 42 caregivers will be enrolled.

Oncologists will then be randomized 1:1 to the BC/WC-GeriOnc intervention arm or waitlist control with optional BC/WC-GeriOnc training after study completion. For each randomized oncologist, the investigators will record cancer treatment decision-making discussions with 5 patients per oncologist and ask participants and oncologists to complete study questionnaires over two-month follow-up and one semi-structured interview about the decision-making process and communication.

Each participant in the pilot CRT phase will be given the option to select one caregiver to participate as well. Caregivers will be asked to complete study questionnaires and a semi-structured interview about their decision-making experience.

Eligibility criteria: Inclusion Criteria for Oncologists:

1. Independently practicing medical oncology physician (non-ACGME oncology fellows who practice independently are eligible).
2. Annually care for at least 10 patients age \>=65 years with solid tumor malignancies in the outpatient setting (this criterion will be confirmed by oncologist report).
3. Willing to complete the two-hour intervention training.
4. At the time of enrollment, plans to continue outpatient practice at a University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center (HDFCCC) affiliated site for the duration of the pilot study.

Inclusion Criteria for Patients:

1. Age \>= 65 years.
2. Diagnosed with a solid tumor malignancy of any stage.
3. 3. Upcoming decision-making discussion (in-person or via video conferencing) with a participating medical oncologist.
4. Able to read, write, and understand English.
5. Able to understand and provide written, informed consent. Adequate decisional capacity to consent for this study will be determined using the UCSF Decision-Making Capacity Assessment Tool. Patients with mild cognitive impairment who have adequate decisional capacity to consent for this study will be included.

There are no performance status, organ function, or comorbidity eligibility criteria for this study.

During the CRT phase, patients will be given the option to select a caregiver to participate in the study (not required). Caregivers cannot participate without an enrolled patient. Caregivers may be a family member, partner, or friend of the participating patient.

Inclusion Criteria for Caregivers:

1. Age \>=18 years.
2. Must plan to be present during the medical oncology decision-making discussion and follow-up visits within the first 3 months.
3. Able to read, write, and understand English.
4. Able to understand and provide written, informed consent.

Exclusion Criteria:

Exclusion Criteria for Oncologists:

1. Medical oncologists who practice solely in the inpatient setting are not eligible.

Exclusion Criteria for Patients:

1. Plan for UCSF second opinion evaluation only. Patients are eligible if they plan to transfer care to UCSF at the time of enrollment.
2. Planned decision-making discussion via phone only (without video).
3. Patients participating in another cancer communication/decision support intervention study with their medical oncologist.

Primary outcomes:
measure: Enrollment rate
timeFrame: 1 day
measure: Retention rate
timeFrame: 3 months
measure: Duration of audio-recorded decision-making discussions
timeFrame: Within 2 weeks after cancer care decision is made for each participating patient
measure: Feasibility of Intervention Measure (Lead-In and BC/WC-GeriOnc Intervention Groups Only)
timeFrame: Within 2 weeks after cancer care decision is made for each participating patient
measure: Qualitative oncologist-reported feasibility (Lead-In and BC/WC-GeriOnc Intervention Groups Only)
timeFrame: Completed once at the end of study participation (approximately 18 months)
Secondary outcomes:
measure: Practitioner Opinion Survey (Lead-In and BC/WC-GeriOnc Intervention Groups Only)
timeFrame: Completed once at the end of study participation (approximately 18 months)
measure: Acceptability of Intervention Measure (Lead-In and BC/WC-GeriOnc Intervention Groups Only)
timeFrame: Within 2 weeks after cancer care decision is made for each participating patient
measure: Intervention Appropriateness Measure (Lead-In and BC/WC-GeriOnc Intervention Groups Only)
timeFrame: Within 2 weeks after cancer care decision is made for each participating patient
measure: BC/WC-GeriOnc Intervention Fidelity (Lead-In and BC/WC-GeriOnc Intervention Groups Only)
timeFrame: Within 2 weeks after cancer care decision is made for each participating patient
measure: BC/WC-GeriOnc Intervention Adherence (Lead-In and BC/WC-GeriOnc Intervention Groups Only)
timeFrame: Within 2 weeks after cancer care decision is made for each participating patient
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital
state: California
city: San Francisco
country: United States
facility: San Francisco Veterans Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Rebecca Debouer, MD, MA
role: PRINCIPAL_INVESTIGATOR
References: