Decision Making for Older Adults With Cancer

NCT05374304 | Completed

• 2 other identifiers: 220521K76AG064431
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 3

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.

Conditions

Cancer

Keywords

Geriatric Oncology; Decision Making

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Completed once at the end of study participation (approximately 18 months)

Secondary Outcomes (5)

• Practitioner Opinion Survey (Lead-In and BC/WC-GeriOnc Intervention Groups Only)

  Completed once at the end of study participation (approximately 18 months)

• 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

• 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

• 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

Study Arms (3)

Lead-In (BC/WC-GeriOnc)

EXPERIMENTAL

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 (BC/WC-GeriOnc)

EXPERIMENTAL

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

Waitlist Control

NO INTERVENTION

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

Interventions

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

Also known as: BC/WC GeriOnc communication tool

Intervention (BC/WC-GeriOnc); Lead-In (BC/WC-GeriOnc)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Independently practicing medical oncology physician (non-ACGME oncology fellows who practice independently are eligible).
• 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).
• Willing to complete the two-hour intervention training.
• 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.
• Age \>= 65 years.
• Diagnosed with a solid tumor malignancy of any stage.
• \. Upcoming decision-making discussion (in-person or via video conferencing) with a participating medical oncologist.
• Able to read, write, and understand English.
• 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.
• Age \>=18 years.
• Must plan to be present during the medical oncology decision-making discussion and follow-up visits within the first 3 months.
• Able to read, write, and understand English.
• Able to understand and provide written, informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Aging (NIA): collaborator
• Mount Zion Health Fund: collaborator

Study Sites (3)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Location

San Francisco Veterans Medical Center

San Francisco, California, 94121, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Rebecca Debouer, MD, MA

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized controlled trial (CRT)

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 16, 2022
• Study Start: July 6, 2022
• Primary Completion: January 22, 2025
• Study Completion: January 22, 2025
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)