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Decision Making for Older Adults With Cancer

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ClinicalTrials.gov Identifier: NCT05374304
Recruitment Status : Recruiting
First Posted : May 16, 2022
Last Update Posted : November 23, 2022
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Mount Zion Health Fund
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Cancer Other: Best Case/Worst Case (BC/WC) Geriatric Oncology (GeriOnc) communication tool Not Applicable

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, 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster randomized controlled trial (CRT)
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Improving Decision Making for Older Adults With Cancer: A Feasibility Pilot Study
Actual Study Start Date : July 6, 2022
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : August 31, 2024

Arm Intervention/treatment
Experimental: 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.
Other: 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.
Other Name: BC/WC GeriOnc communication tool

Experimental: 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.
Other: 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.
Other Name: BC/WC GeriOnc communication tool

No Intervention: Waitlist Control
Usual care will be provided to the patients, with optional training for the oncologists at study completion.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria 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 >=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.

Inclusion Criteria for Patients:

  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.

Inclusion Criteria for Caregivers:

  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:

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. Planned decision-making discussion via phone only (without video).
  3. Patients participating in another cancer communication/decision support intervention study with their medical oncologist.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05374304


Contacts
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Contact: Sandra Zeng 415-502-3014 BCWCGeriOnc@ucsf.edu

Locations
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United States, California
Zuckerberg San Francisco General Hospital Not yet recruiting
San Francisco, California, United States, 94110
Principal Investigator: Rebecca DeBoer, MD, MA         
San Francisco Veterans Medical Center Not yet recruiting
San Francisco, California, United States, 94121
Principal Investigator: Li-Wen Huang, MD         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Sandra Zeng    415-502-3014    BCWCGeriOnc@ucsf.edu   
Contact       cancertrials@ucsf.edu   
Principal Investigator: Melisa L Wong, MD, MAS         
Sponsors and Collaborators
University of California, San Francisco
National Institute on Aging (NIA)
Mount Zion Health Fund
Investigators
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Principal Investigator: Melisa L Wong, MD, MAS University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05374304    
Other Study ID Numbers: 22052
1K76AG064431 ( U.S. NIH Grant/Contract )
First Posted: May 16, 2022    Key Record Dates
Last Update Posted: November 23, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Geriatric Oncology
Decision Making