Improving Decision Making for Older Adults With Cancer: A Feasibility Pilot Study
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 65
- Locations
- 3
- Primary Endpoint
- Enrollment rate
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Exclusion Criteria for Oncologists:
- •Medical oncologists who practice solely in the inpatient setting are not eligible.
- •Exclusion Criteria for Patients:
- •Plan for UCSF second opinion evaluation only. Patients are eligible if they plan to transfer care to UCSF at the time of enrollment.
- •Planned decision-making discussion via phone only (without video).
- •Patients participating in another cancer communication/decision support intervention study with their medical oncologist.
Outcomes
Primary Outcomes
Enrollment rate
Time Frame: 1 day
Proportion of eligible patients who enroll in the study. An enrollment rate \>=50% will be used to determine overall feasibility, which was selected based on decreased enrollment observed in studies of older adults with cancer during the ongoing 2019 novel coronavirus (COVID-19) pandemic.
Retention rate
Time Frame: 3 months
Proportion of oncologists, participants, and caregivers who complete the study. A completion rate of \>=75% study completion excluding drop out due to death will be used to determine overall feasibility.
Duration of audio-recorded decision-making discussions
Time Frame: Within 2 weeks after cancer care decision is made for each participating patient
The duration of audio-recorded decision-making discussions in the intervention group will be compared with the duration in the control group. The investigators will compare the duration of the overall patient visit, the decision-making discussion portion of the patient visit, and the decision-making discussion portion of the patient visit plus any subsequent follow-up discussions until the decision is made.
Feasibility of Intervention Measure (Lead-In and BC/WC-GeriOnc Intervention Groups Only)
Time Frame: Within 2 weeks after cancer care decision is made for each participating patient
Oncologists will complete the Feasibility of Intervention Measure, which includes 4 items with responses rated on a 5-point Likert scale from completely disagree to completely agree. The measure is scored by calculating the mean of the responses with a higher score indicating greater feasibility.
Qualitative oncologist-reported feasibility (Lead-In and BC/WC-GeriOnc Intervention Groups Only)
Time Frame: Completed once at the end of study participation (approximately 18 months)
Oncologists will participate in one semi-structured interview at study completion to learn about their perspectives on intervention feasibility.
Secondary Outcomes
- BC/WC-GeriOnc Intervention Fidelity (Lead-In and BC/WC-GeriOnc Intervention Groups Only)(Within 2 weeks after cancer care decision is made for each participating patient)
- Practitioner Opinion Survey (Lead-In and BC/WC-GeriOnc Intervention Groups Only)(Completed once at the end of study participation (approximately 18 months))
- BC/WC-GeriOnc Intervention Adherence (Lead-In and BC/WC-GeriOnc Intervention Groups Only)(Within 2 weeks after cancer care decision is made for each participating patient)
- Acceptability of Intervention Measure (Lead-In and BC/WC-GeriOnc Intervention Groups Only)(Within 2 weeks after cancer care decision is made for each participating patient)
- Intervention Appropriateness Measure (Lead-In and BC/WC-GeriOnc Intervention Groups Only)(Within 2 weeks after cancer care decision is made for each participating patient)