CancerNCT05374304
Decision Making for Older Adults With Cancer
A study testing Best Case/Worst Case (BC/WC) Geriatric Oncology (GeriOnc) communication tool in people with Cancer, run by University of California, San Francisco at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Best Case/Worst Case (BC/WC) Geriatric Oncology (GeriOnc) communication tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Jul 2022to 22 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Show all 15Show fewer
- 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.
- 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.
Who cannot join
- 1. 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
San Francisco Veterans Medical Center
San Francisco, California, 94121
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Improving Decision Making for Older Adults With Cancer: A Feasibility Pilot Study
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.
Read the detailed description
Primary Objective:
- 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
- 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:
- 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
- Being tested
- Best Case/Worst Case (BC/WC) Geriatric Oncology (GeriOnc) communication tool
- Keywords
- Geriatric Oncology, Decision Making
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best Case/Worst Case (BC/WC) Geriatric Oncology (GeriOnc) communication toolOther
Also called BC/WC 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: Completed once at the end of study participation (approximately 18 months)
Acceptability of Intervention Measure (Lead-In and BC/WC-GeriOnc Intervention Groups Only)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
Proportion of study visits with participating patients during which oncologists use the BC/WC-GeriOnc communication tool.
Measured: Within 2 weeks after cancer care decision is made for each participating patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start6 Jul 2022
- Primary completion22 Jan 2025
- Study completion22 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled trial (CRT)
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Mount Zion Health Fund
- Responsible party
- Sponsor
- Investigators
- Rebecca Debouer, MD, MA, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374304
- Sponsor's protocol ID
- 22052
- Other IDs
- 1K76AG064431
- Status last verified
- Jan 2025
- First submitted
- 10 May 2022
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Decision Making for Older Adults With Cancer: A Feasibility Pilot Study
- ClinicalTrials.gov ID
- NCT05374304
- Acronym / sponsor ID
- 22052
- Conditions
- Cancer
- Keywords
- Geriatric Oncology, Decision Making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Mount Zion Health Fund
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 22 Jan 2025 (actual)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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:
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Cluster randomized controlled trial (CRT)
| Arm | Type | Receives |
|---|---|---|
| Lead-In (BC/WC-GeriOnc) | Experimental | Other: Best Case/Worst Case (BC/WC) Geriatric Oncology (GeriOnc) communication toolLead-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. |
| Intervention (BC/WC-GeriOnc) | Experimental | Other: Best Case/Worst Case (BC/WC) Geriatric Oncology (GeriOnc) communication toolIntervention 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. |
| Waitlist Control | No intervention | –Usual care will be provided to the patients, with optional training for the oncologists at study completion. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (4 listed)
- 1. 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best Case/Worst Case (BC/WC) Geriatric Oncology (GeriOnc) communication toolAlso: BC/WC GeriOnc communication toolThe 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 | Intervention (BC/WC-GeriOnc), Lead-In (BC/WC-GeriOnc) |
Primary outcome
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.
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.
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.
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.
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.
5 secondary outcomes
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)
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Debouer, MD, MA principal investigator
University of California, San Francisco
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Case/Worst Case (BC/WC) Geriatric Oncology (GeriOnc) communication tool in people with Cancer, run by University of California, San Francisco at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rate (time frame: 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.