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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UR-GOAL | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 1-4 weeks after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Patients
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
Oncologists
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| Name | Affiliation | Role |
|---|---|---|
| Kah Poh Loh | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34043434 | Background | 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. | |
| 33040623 | Background | Loh 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. |
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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.
The data will be available for 7 years after study completion
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Patients aged 60 and above with AML were recruited from June 2022 to July 2025. Patients were recruited from 1) the Wilmot Cancer Institute inpatient malignant hematology service and 2) hematology clinics at Wilmot Cancer Institute.
Enrolled patients could enroll with a caregiver, but were not required to. Oncologists at the Wilmot Cancer Institute were eligible if they treated at least one enrolled patient.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient: UR-GOAL Intervention | 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. |
| FG001 | Patient: Usual Care Control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 15, 2026 |
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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.
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| Within 1-4 weeks after treatment initiation |
| 42275539 | Derived | Jensen-Battaglia M, Mortaz Hedjri S, Blumberg R, Oh E, Fallone-Sharma C, Wang Y, Nafis L, Mendler JH, Rodenbach R, Huselton EJ, Liesveld JL, 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 Jun 11:bloodadvances.2025019276. doi: 10.1182/bloodadvances.2025019276. Online ahead of print. |
| 38336521 | Derived | Jensen-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. |
Usual care |
| FG002 | Caregiver: UR-GOAL Intervention | Patients had the option to enroll with a caregiver. Caregivers were assigned to the same study arm as the patient with whom they enrolled. Before the AML treatment decision was made, caregivers in the UR-GOAL Intervention arm were provided with the same summary report and AML educational video as the patients. |
| FG003 | Caregiver: Usual Care Control | Patients had the option to enroll with a caregiver. Caregivers were assigned to the same study arm as the patient with whom they enrolled. Caregivers in the Usual Care Control were not provided with additional information beyond usual care. |
| FG004 | Oncologist | Oncologists treated patients who were allocated to either study arm. For patients in the UR-GOAL Intervention arm, the oncologist received a summary report containing the patient's treatment preferences, fitness level, and prognostic awareness. Oncologists did not receive this report for patients allocated to the Usual Care Control arm. Oncologists provided both data about themselves (for example, demographics) and data about the enrolled patients they treated (for example, disease understanding). |
| COMPLETED | "Completed" is defined as participants who reached the post-intervention assessment within 4 weeks after treatment initiation, corresponding to the primary outcome timepoint. Participants may have continued follow-up beyond this timepoint. Deaths in Participant Flow reflect events before this assessment, while additional deaths during follow-up are included in All-Cause Mortality. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient: UR-GOAL Intervention | 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. |
| BG001 | Patient: Usual Care Control | Usual care |
| BG002 | Caregiver: UR-GOAL Intervention | Patients had the option to enroll with a caregiver. Caregivers were assigned to the same study arm as the patient with whom they enrolled. Before the AML treatment decision was made, caregivers in the UR-GOAL Intervention arm were provided with the same summary report and AML educational video as the patients. |
| BG003 | Caregiver: Usual Care Control | Patients had the option to enroll with a caregiver. Caregivers were assigned to the same study arm as the patient with whom they enrolled. Caregivers in the Usual Care Control were not provided with additional information beyond usual care. |
| BG004 | Oncologist | Oncologists treated patients who were allocated to either study arm. For patients in the UR-GOAL Intervention arm, the oncologist received a summary report containing the patient's treatment preferences, fitness level, and prognostic awareness. Oncologists did not receive this report for patients allocated to the Usual Care Control arm. Oncologists provided both data about themselves (for example, demographics) and data about the enrolled patients they treated (for example, disease understanding). |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | One oncologist declined to provide their year of birth | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Marital Status | Oncologists did not report their marital status. | Count of Participants | Participants |
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| Education | Oncologists did not report their education. | Count of Participants | Participants |
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| Employment | Oncologists did not report their employment. | Count of Participants | Participants |
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| ECOG (KPS) | Eastern Cooperative Oncology Group (ECOG) Performance Status is a clinician scale of 0-5 that ranks patient functional level from 0 (best) to 5 (worst). The Karnofsky Performance Status (KPS) is a comparable scale for cancer patients, and ranges from 0 (worst) to 100 (best). | Oncologists and Caregivers did not report their ECOG (KPS). | Count of Participants | Participants |
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| Physical Function | 4 measures comprised the physical function impairment: Short Performance Physical Battery (a short physical test), Activities of Daily Living (a survey about ability to perform daily activities, such as bathing and dressing), Instrumental Activities of Daily Living (a survey about ability to perform routine functions, such as shopping and cooking), and fall history. If the SPPB total score was less than 10, patient could not do any item on the ADL or IADL, or there was a fall within the last 6 months, then Physical Function was considered impaired (negative outcome). | Oncologists and Caregivers did not report their Physical Function. | Count of Participants | Participants |
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| Mini-Cog | The Mini-Cog is a three-item recall and clock-drawing test to screen for cognitive impairment. Patients who cannot recall any of the 3 words, or recall 1-2 out of 3 words with an abnormal clock-drawing are considered impaired. | Oncologists and Caregivers did not report their Mini-Cog. | Count of Participants | Participants |
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| GDS-15 | The GDS-15 ranges from 0 to 15, with a higher score indicating more depression. A score of 5 or higher was considered impaired. | Oncologists and Caregivers did not report their GDS-15. | Count of Participants | Participants |
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| Nutrition | Patient nutrition was assessed with BMI and self-reported weight loss. Patient nutrition was considered impaired if BMI was less than or equal to 21 or 6 month weight loss exceeded 10%. | Oncologists and Caregivers did not report their Nutrition. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | 5 patients who completed some of the post-intervention surveys did not complete the SDM-Q-9 form. | Posted | Mean | Standard Deviation | Score on a Scale | Within 1-4 weeks after treatment initiation |
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| Secondary | 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. | Analysis populations vary across domains due to missing responses and "does not apply" selections for specific items. Participants were included in each domain analysis if sufficient data were available for that domain. | Posted | Mean | Standard Deviation | Score on a Scale | Within 1-4 weeks after treatment initiation |
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Patient adverse event and mortality data were collected and reported from enrollment until end of patient follow-up, up to approximately 6 months after enrollment. Caregiver adverse event and mortality data were collected and reported from enrollment until end of caregiver follow-up, up to approximately 6 weeks after enrollment. Oncologist adverse event and mortality data were collected and reported from enrollment until end of study, up to approximately 3 years.
Adverse events were assessed for study intervention or procedure-related events only. Events related to standard-of-care cancer treatments were not collected per protocol. Mortality was reported for 6 months after enrollment, including participants who withdrew but did not withdraw consent. Deaths after the primary outcome timepoint are included in All-Cause Mortality but not Participant Flow.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patient: UR-GOAL Intervention | 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. | 12 | 50 | 0 | 50 | 0 | 50 |
| EG001 | Patient: Usual Care Control | Usual care | 10 | 50 | 0 | 50 | 0 | 50 |
| EG002 | Caregiver: UR-GOAL Intervention | Patients had the option to enroll with a caregiver. Caregivers were assigned to the same study arm as the patient with whom they enrolled. Before the AML treatment decision was made, caregivers in the UR-GOAL Intervention arm were provided with the same summary report and AML educational video as the patients. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG003 | Caregiver: Usual Care Control | Patients had the option to enroll with a caregiver. Caregivers were assigned to the same study arm as the patient with whom they enrolled. Caregivers in the Usual Care Control were not provided with additional information beyond usual care. | 0 | 28 | 0 | 28 | 0 | 28 |
| EG004 | Oncologist | Oncologists treated patients who were allocated to either study arm. For patients in the UR-GOAL Intervention arm, the oncologist received a summary report containing the patient's treatment preferences, fitness level, and prognostic awareness. Oncologists did not receive this report for patients allocated to the Usual Care Control arm. Oncologists provided both data about themselves (for example, demographics) and data about the enrolled patients they treated (for example, disease understanding). | 0 | 8 | 0 | 8 | 0 | 8 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kah Poh Loh | University of Rochester Medical Center | 585-276-4353 | kahpoh_loh@urmc.rochester.edu |
| Mar 25, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Patient | Dec 13, 2023 | Mar 25, 2026 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Caregiver | Dec 13, 2023 | Mar 25, 2026 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Oncologist | Dec 13, 2023 | Mar 25, 2026 | ICF_003.pdf |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D003142 | Communication |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001519 | Behavior |
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