Decision Making for Older Adults With Cancer

NCT ID: NCT05374304

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-06
• Study Completion Date: 2025-01-22

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Lead-In (BC/WC-GeriOnc)

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.

Group Type: EXPERIMENTAL

Best Case/Worst Case (BC/WC) Geriatric Oncology (GeriOnc) communication tool

Intervention Type: OTHER

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.

Intervention (BC/WC-GeriOnc)

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.

Group Type: EXPERIMENTAL

Best Case/Worst Case (BC/WC) Geriatric Oncology (GeriOnc) communication tool

Intervention Type: OTHER

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.

Waitlist Control

Usual care will be provided to the patients, with optional training for the oncologists at study completion.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Best Case/Worst Case (BC/WC) Geriatric Oncology (GeriOnc) communication tool

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.

Intervention Type: OTHER

Other Intervention Names

BC/WC GeriOnc communication tool

Eligibility Criteria

Inclusion Criteria

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.

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.

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

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

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Mount Zion Health Fund

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca Debouer, MD, MA

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

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

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1K76AG064431

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22052

Identifier Type: -

Identifier Source: org_study_id