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Completed

NCT Number: NCT05374304

Decision Making for Older Adults With Cancer

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.

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Oncologists:

  • 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.

Inclusion criteria

for Patients:

  • Age >= 65 years.
  • Diagnosed with a solid tumor malignancy of any stage.
  • 3. 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.

Inclusion criteria

for Caregivers:

  • 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.

Exclusion criteria

Exclusion criteria

for Oncologists:

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

Exclusion criteria

for Patients:

  • 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.

Treatment and study plan

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.

Other names: BC/WC GeriOnc communication tool

Primary outcomes

  1. Enrollment rate

    Time frame: 1 day

    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.

  2. Retention rate

    Time frame: 3 months

    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. Duration of audio-recorded decision-making discussions

    Time frame: Within 2 weeks after cancer care decision is made for each participating patient

    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.

  4. Feasibility of Intervention Measure (Lead-In and BC/WC-GeriOnc Intervention Groups Only)

    Time frame: Within 2 weeks after cancer care decision is made for each participating patient

    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.

  5. Qualitative oncologist-reported feasibility (Lead-In and BC/WC-GeriOnc Intervention Groups Only)

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

    Oncologists will participate in one semi-structured interview at study completion to learn about their perspectives on intervention feasibility.

Secondary outcomes

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

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

    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.

  2. Acceptability of Intervention Measure (Lead-In and BC/WC-GeriOnc Intervention Groups Only)

    Time frame: Within 2 weeks after cancer care decision is made for each participating patient

    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.

  3. Intervention Appropriateness Measure (Lead-In and BC/WC-GeriOnc Intervention Groups Only)

    Time frame: Within 2 weeks after cancer care decision is made for each participating patient

    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.

  4. BC/WC-GeriOnc Intervention Fidelity (Lead-In and BC/WC-GeriOnc Intervention Groups Only)

    Time frame: Within 2 weeks after cancer care decision is made for each participating patient

    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.

  5. BC/WC-GeriOnc Intervention Adherence (Lead-In and BC/WC-GeriOnc Intervention Groups Only)

    Time frame: Within 2 weeks after cancer care decision is made for each participating patient

    Proportion of study visits with participating patients during which oncologists use the BC/WC-GeriOnc communication tool.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Mount Zion Health Fund
  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 16, 2022
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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