Acute Myeloid LeukemiaUR-GOAL 2NCT05335369
A Patient-Centered Communication Tool (UR-GOAL) Versus Usual Care for Older Patients With Acute Myeloid Leukemia, Their Caregivers, and Their Oncologists
A study testing UR-GOAL in people with Acute Myeloid Leukemia, run by University of Rochester at 1 site in United States.
Trial summary
The objective of this study is to evaluate the preliminary efficacy of the UR-GOAL tool in improving shared decision making and communication between older patients with AML and their oncologists in a pilot randomized trial. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- UR-GOAL
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2022to 6 Oct 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients
- Age ≥60 years
- Newly diagnosed AML or being worked up for possible AML
- Able to provide informed consent
- Agreement of their oncologist to participate in the study
- English-speaking
Show all 15Show fewer
- If patients screen positive for cognitive impairment on the Mini-Cog test performed as part of the baseline assessment, they can still enroll if they are able to provide informed consent and have decision making capacity as determined by their treating oncologist
- Caregivers
- Selected by the patient when asked if there is a "family member, partner, friend or caregiver [age 21 or older] with whom the patient discuss or who can be helpful in health-related matters;" patients who cannot identify such a person ("caregiver") can be eligible for the study. A caregiver need not be someone who lives with the patient or provides direct hands-on care. A caregiver can be any person who provides support (in any way) to the patient
- Able to provide informed consent
- English-speaking
- Oncologists
- A practicing oncologist
- At least one of their patients are recruited to the study
- English-speaking
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Randomized Controlled Trial of a Patient-centered Communication Tool (UR-GOAL) for Older Patients With Acute Myeloid Leukemia, Their Caregivers, and Their Oncologists
The objective of this study is to evaluate the preliminary efficacy of the UR-GOAL tool in improving shared decision making and communication between older patients with AML and their oncologists in a pilot randomized trial.
Read the detailed description
The investigators have developed a patient-centered communication tool (University of Rochester-Geriatric Oncology assessment for Acute myeloid Leukemia or UR-GOAL) that 1) conducts assessments of fitness, 2) elicits patient values via Best-Worst Scaling, and 3) elicits preferences for prognostic information and assesses prognostic awareness. The tool also includes an AML educational video. The investigators have refined the tool based on feedback from stakeholders consisting of older patients with cancer, caregivers, and oncologists. This was further adapted in a qualitative study of 15 older patients with AML. In a single arm pilot study, the investigators have demonstrated feasibility of recruiting older patients with newly diagnosed AML to a single arm study, as well as their caregivers and oncologists.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- UR-GOAL
- Keywords
- Acute myeloid leukemia, communication, shared decision making, older adults, geriatric hematology
- Medical subject headings
- Leukemia, Myeloid, Acute, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UR-GOALBehavioural
UR-GOAL helps conducts assessments of fitness, elicits patient values via Best-Worst Scaling, and elicits preferences for prognostic information and assesses prognostic awareness. The tool also includes an AML educational video.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Usual care |
| UR-GOAL | Experimental | UR-GOAL helps conducts assessments of fitness, elicits patient values via Best-Worst Scaling, and elicits preferences for prognostic information and assesses prognostic awareness. The tool also includes an AML educational video. Receives: Behavioral: UR-GOAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shared Decision Making
A 9-item Shared Decision Making questionnaire (SDM-Q-9) assessing patient satisfaction with the medical decision-making process. Scores are transformed to a 0-100 scale in accordance with measure guidelines, with higher scores indicating greater shared decision making between the patient and the provider.
Measured: Within 1-4 weeks after treatment initiation
Secondary outcomes (1)
Patient-Centered Communication in Cancer Care (PCC-Ca-36)
A 36-item questionnaire assessing patient-centered communication in six domains: exchanging information, making decisions, fostering healing relationships, enabling patient self-management, managing uncertainty, and responding to emotions. The overall score and scores in each domain range from 1-5, higher scores indicate better communication.
Measured: Within 1-4 weeks after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start17 Jun 2022
- Primary completion7 Apr 2025
- Study completion6 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The UR-GOAL 1) conducts assessments of fitness, 2) elicits patient values via Best-Worst Scaling, and 3) elicits preferences for prognostic information and assesses prognostic awareness. The tool also includes an AML educational video.
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kah Poh Loh, University of Rochester
- Investigators
- Kah Poh Loh, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335369
- Sponsor's protocol ID
- UOCPC22010
- Acronym
- UR-GOAL 2
- Status last verified
- Mar 2026
- First submitted
- 12 Apr 2022
- Last updated
- 11 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared with other investigators if requested. The investigators will publish our study protocol. Published papers will be made available in portable document format.
Publications
DuMontier C, Loh KP, Soto-Perez-de-Celis E, Dale W. Decision Making in Older Adults With Cancer. J Clin Oncol. 2021 Jul 1;39(19):2164-2174. doi: 10.1200/JCO.21.00165. Epub 2021 May 27. No abstract available.
PubMed 34043434Loh KP, Abdallah M, Kadambi S, Wells M, Kumar AJ, Mendler JH, Liesveld JL, Wittink M, O'Dwyer K, Becker MW, McHugh C, Stock W, Majhail NS, Wildes TM, Duberstein P, Mohile SG, Klepin HD. Treatment decision-making in acute myeloid leukemia: a qualitative study of older adults and community oncologists. Leuk Lymphoma. 2021 Feb;62(2):387-398. doi: 10.1080/10428194.2020.1832662. Epub 2020 Oct 11.
PubMed 33040623Jensen-Battaglia M, Mortaz-Hedjri S, Blumberg R, Oh E, Fallone-Sharma C, Wang Y, Nafis L, Mendler J, Rodenbach R, Huselton E, Liesveld J, Terhune J, Terhune J, Agree EM, Block RC, Seplaki CL, Mohile SG, Loh KP. Patient and oncologist expectations of functional prognosis among older adults with acute myeloid leukemia. Blood Adv. 2026 Aug 11;10(15):5389-5399. doi: 10.1182/bloodadvances.2025019276.
PubMed 42275539Jensen-Battaglia M, LoCastro M, Oh H, Sanapala C, Flannery M, Mendler JH, Liesveld J, Huselton E, Loh KP. Patient-oncologist discussion of treatment decisions: Exploring the role of a patient-centered communication tool for older adults with acute myeloid leukemia and their caregivers. J Geriatr Oncol. 2024 Jun;15(5):101716. doi: 10.1016/j.jgo.2024.101716. Epub 2024 Feb 9. No abstract available.
PubMed 38336521
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial of a Patient-centered Communication Tool (UR-GOAL) for Older Patients With Acute Myeloid Leukemia, Their Caregivers, and Their Oncologists
- ClinicalTrials.gov ID
- NCT05335369
- Acronym / sponsor ID
- UR-GOAL 2 / UOCPC22010
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute myeloid leukemia, communication, shared decision making, older adults, geriatric hematology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 6 Oct 2025 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Posted 11 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the preliminary efficacy of the UR-GOAL tool in improving shared decision making and communication between older patients with AML and their oncologists in a pilot randomized trial.
Detailed description
The investigators have developed a patient-centered communication tool (University of Rochester-Geriatric Oncology assessment for Acute myeloid Leukemia or UR-GOAL) that 1) conducts assessments of fitness, 2) elicits patient values via Best-Worst Scaling, and 3) elicits preferences for prognostic information and assesses prognostic awareness. The tool also includes an AML educational video. The investigators have refined the tool based on feedback from stakeholders consisting of older patients with cancer, caregivers, and oncologists. This was further adapted in a qualitative study of 15 older patients with AML. In a single arm pilot study, the investigators have demonstrated feasibility of recruiting older patients with newly diagnosed AML to a single arm study, as well as their caregivers and oncologists.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The UR-GOAL 1) conducts assessments of fitness, 2) elicits patient values via Best-Worst Scaling, and 3) elicits preferences for prognostic information and assesses prognostic awareness. The tool also includes an AML educational video.
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Usual care |
| UR-GOAL | Experimental | Behavioral: UR-GOALUR-GOAL helps conducts assessments of fitness, elicits patient values via Best-Worst Scaling, and elicits preferences for prognostic information and assesses prognostic awareness. The tool also includes an AML educational video. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients
- Age ≥60 years
- Newly diagnosed AML or being worked up for possible AML
- Able to provide informed consent
- Agreement of their oncologist to participate in the study
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| UR-GOALUR-GOAL helps conducts assessments of fitness, elicits patient values via Best-Worst Scaling, and elicits preferences for prognostic information and assesses prognostic awareness. The tool also includes an AML educational video. | Behavioural | UR-GOAL |
Primary outcome
Shared Decision Making
Time frame: Within 1-4 weeks after treatment initiation
A 9-item Shared Decision Making questionnaire (SDM-Q-9) assessing patient satisfaction with the medical decision-making process. Scores are transformed to a 0-100 scale in accordance with measure guidelines, with higher scores indicating greater shared decision making between the patient and the provider.
1 secondary outcome
Patient-Centered Communication in Cancer Care (PCC-Ca-36)
Time frame: Within 1-4 weeks after treatment initiation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34043434DuMontier C, Loh KP, Soto-Perez-de-Celis E, Dale W. Decision Making in Older Adults With Cancer. J Clin Oncol. 2021 Jul 1;39(19):2164-2174. doi: 10.1200/JCO.21.00165. Epub 2021 May 27. No abstract available.
- Background: PubMed 33040623Loh KP, Abdallah M, Kadambi S, Wells M, Kumar AJ, Mendler JH, Liesveld JL, Wittink M, O'Dwyer K, Becker MW, McHugh C, Stock W, Majhail NS, Wildes TM, Duberstein P, Mohile SG, Klepin HD. Treatment decision-making in acute myeloid leukemia: a qualitative study of older adults and community oncologists. Leuk Lymphoma. 2021 Feb;62(2):387-398. doi: 10.1080/10428194.2020.1832662. Epub 2020 Oct 11.
- Derived from this study: PubMed 42275539Jensen-Battaglia M, Mortaz-Hedjri S, Blumberg R, Oh E, Fallone-Sharma C, Wang Y, Nafis L, Mendler J, Rodenbach R, Huselton E, Liesveld J, Terhune J, Terhune J, Agree EM, Block RC, Seplaki CL, Mohile SG, Loh KP. Patient and oncologist expectations of functional prognosis among older adults with acute myeloid leukemia. Blood Adv. 2026 Aug 11;10(15):5389-5399. doi: 10.1182/bloodadvances.2025019276.
- Derived from this study: PubMed 38336521Jensen-Battaglia M, LoCastro M, Oh H, Sanapala C, Flannery M, Mendler JH, Liesveld J, Huselton E, Loh KP. Patient-oncologist discussion of treatment decisions: Exploring the role of a patient-centered communication tool for older adults with acute myeloid leukemia and their caregivers. J Geriatr Oncol. 2024 Jun;15(5):101716. doi: 10.1016/j.jgo.2024.101716. Epub 2024 Feb 9. No abstract available.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with other investigators if requested. The investigators will publish our study protocol. Published papers will be made available in portable document format.
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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.
Kah Poh Loh principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UR-GOAL in people with Acute Myeloid Leukemia, run by University of Rochester at 1 site 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 0 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 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 11 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Shared Decision Making (time frame: Within 1-4 weeks after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05335369, which also lists 4 linked publications.
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 11 May 2026.