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Spots Global Cancer Trial Database for Decision Making for Older Adults With Cancer

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Trial Identification

Brief Title: Decision Making for Older Adults With Cancer

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

Study ID: NCT05374304

Conditions

Cancer

Study Description

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

Minimum Age: 65 Years

Eligible Ages: OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Zuckerberg San Francisco General Hospital, San Francisco, California, United States

San Francisco Veterans Medical Center, San Francisco, California, United States

University of California, San Francisco, San Francisco, California, United States

Contact Details

Name: Rebecca Debouer, MD, MA

Affiliation: University of California, San Francisco

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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