Summary

Eligibility
for people ages 70 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Melisa L Wong, MD, MAS
Headshot of Melisa L Wong
Melisa L Wong

Description

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 advanced cancer.

Official Title

Improving Decision Making for Older Adults With Cancer: A Feasibility Pilot Study

Details

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 advanced 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 initial 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, 6 medical oncologists, 42 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.

Keywords

Advanced Cancer Geriatric Oncology Decision Making Best Case/Worst Case (BC/WC) Geriatric Oncology (GeriOnc) communication tool Lead-In (BC/WC-GeriOnc)

Eligibility

You can join if…

Open to people ages 70 years and up

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 >=70 years with stage IV 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 >= 70 years
  2. Newly diagnosed stage IV (per American Joint Committee on Cancer (AJCC) 8th Edition) solid tumor malignancy. Clinical staging without pathological confirmation of stage IV disease is allowed. Patients with oligometastatic disease are eligible.
  3. Upcoming new patient appointment (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 new patient visit (NPV) and initial 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.

You CAN'T join if...

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. Patients who have already made an initial cancer care decision regarding first-line care with another non-participating medical oncologist. This exclusion criterion will be determined based on medical record review and confirmation with the patient.
  3. New patient appointment via phone only (without video).
  4. Patients participating in another cancer communication/decision support intervention study with their medical oncologist.

Locations

  • Zuckerberg San Francisco General Hospital
    San Francisco California 94110 United States
  • University of California, San Francisco
    San Francisco California 94143 United States
  • San Francisco Veterans Medical Center
    San Francisco California 94121 United States

Lead Scientist at UCSF

  • Melisa L Wong, MD, MAS
    Melisa Wong, MD, MAS is a thoracic oncologist who treats patients with lung cancer and other thoracic malignancies. Dr. Wong has a particular interest in caring for older adults with cancer. Her goal is to provide personalized cancer care based on patients’ values and goals. Dr. Wong’s research focuses on understanding and improving patient-centered outcomes in older adults with cancer.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05374304
Study Type
Interventional
Participants
Expecting 96 study participants
Last Updated