An interventional study of Best Case/Worst Case (BC/WC) Geriatric Oncology (GeriOnc) communication tool in Cancer, sponsored by University of California, San Francisco. Completed at 3 sites in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-01-23.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Other
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.
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.
University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for Oncologists:
Inclusion Criteria for Patients:
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:
Exclusion Criteria:
Exclusion Criteria for Oncologists:
Exclusion Criteria for Patients:
Lead-in phase oncologists will complete the BC/WC-GeriOnc communication tool training. Cancer treatment decision-making discussions will be recorded with 2 patients per oncologist and ask patients and oncologists to complete study questionnaires over one-month follow-up and one semi-structured interview about the decision-making process and communication.
Other: Best Case/Worst Case (BC/WC) Geriatric Oncology (GeriOnc) communication tool
Intervention group oncologists will complete the BC/WC-GeriOnc communication tool training. Cancer treatment decision-making discussions will be recorded with 2 patients per oncologist to understand baseline oncologist practices and communication. Patients and oncologists will be asked to complete study questionnaires over a 2 month follow-up and 1 semi-structured interview. For each randomized oncologist, cancer treatment decision-making discussions will be recorded with 5 patients per oncologist. Both patients and oncologists will also be asked to complete study questionnaires over a 2 month follow-up and 1 semi-structured interview about the decision-making process and communication. Each patient will be given the option to select 1 caregiver to participate. Caregivers will be asked to complete study questionnaires and a semi-structured interview about their decision-making experience.
Other: Best Case/Worst Case (BC/WC) Geriatric Oncology (GeriOnc) communication tool
Usual care will be provided to the patients, with optional training for the oncologists at study completion.
The BC/WC framework guides clinicians to present a choice between two options and uses scenario planning (narrative descriptions of plausible outcomes that acknowledge uncertainty) to describe the best, worst, and most likely case for each option. Scenarios are informed by clinical judgement and knowledge of patient risk factors. These scenarios plus an accompanying graphic aid help patients formulate and express preferences and concerns about treatment burdens and outcomes. The clinician then provides a goal-concordant recommendation.
Also known as: BC/WC GeriOnc communication tool
Enrollment rate
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.
Time frame: 1 day
Retention rate
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.
Time frame: 3 months
Duration of audio-recorded decision-making discussions
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.
Time frame: Within 2 weeks after cancer care decision is made for each participating patient
Feasibility of Intervention Measure (Lead-In and BC/WC-GeriOnc Intervention Groups Only)
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.
Time frame: Within 2 weeks after cancer care decision is made for each participating patient
Qualitative oncologist-reported feasibility (Lead-In and BC/WC-GeriOnc Intervention Groups Only)
Oncologists will participate in one semi-structured interview at study completion to learn about their perspectives on intervention feasibility.
Time frame: Completed once at the end of study participation (approximately 18 months)
Practitioner Opinion Survey (Lead-In and BC/WC-GeriOnc Intervention Groups Only)
Oncologists will complete the Practitioner Opinion Survey, which includes 15 items to assess physician perspectives on using a decision aid including ease of use and benefits compared with their usual approach. The investigator will modify the survey to refer to BC/WC-GeriOnc as the intervention.
Time frame: Completed once at the end of study participation (approximately 18 months)
Acceptability of Intervention Measure (Lead-In and BC/WC-GeriOnc Intervention Groups Only)
Oncologists will complete the Acceptability 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 acceptability.
Time frame: 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)
Oncologists will complete the Intervention Appropriateness 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 appropriateness.
Time frame: Within 2 weeks after cancer care decision is made for each participating patient
BC/WC-GeriOnc Intervention Fidelity (Lead-In and BC/WC-GeriOnc Intervention Groups Only)
The BC/WC-GeriOnc Communication Tool Skills Checklist will used to assess intervention fidelity by evaluating audio-recordings and graphic aids after each use of BC/WC-GeriOnc. The BC/WC-GeriOnc Communication Tool Skills Checklist was adapted from the original 15-item checklist for the BC/WC communication tool. This checklist includes essential elements of the intervention and will be used to evaluate oncologist proficiency at the end of intervention training and to assess fidelity to the intervention during the study.
Time frame: Within 2 weeks after cancer care decision is made for each participating patient
BC/WC-GeriOnc Intervention Adherence (Lead-In and BC/WC-GeriOnc Intervention Groups Only)
Proportion of study visits with participating patients during which oncologists use the BC/WC-GeriOnc communication tool.
Time frame: Within 2 weeks after cancer care decision is made for each participating patient
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, San Francisco