OncologyUR-GOAL RCTNCT06697600
A Decisional Intervention for Older Adults With Acute Myeloid Leukemia and Their Caregivers
A study testing UR-GOAL in people with Oncology and Myeloid Leukemia, Acute, run by University of Rochester at 4 sites in United States.
Trial summary
This is a multicenter randomized controlled trial that assesses the efficacy of a decisional intervention [University of Rochester-Geriatric Oncology assessment for Acute myeloid Leukemia (UR-GOAL)] compared to an attention control. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Oncology, Myeloid Leukemia, Acute, Cancer
- 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
- 1,020 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Jul 2025to 1 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥60 years (from date of consent, confirmed on electronic medical records)
- A new diagnosis of AML
- Diagnosis can be based on the International Consensus Classification or World Health Organization
- Myeloid sarcoma is allowed
- AML with central nervous system involvement is allowed
- Cancer-directed treatment has not started
Show all 21Show fewer
- Treatment to temporarily decrease white blood cells is acceptable; these may include hydroxyurea, leukapheresis, or cytarabine
- Intrathecal chemotherapy is acceptable
- The patient's oncologist has been or will be enrolled on the study
- English or Spanish-speaking
- Patients without a caregiver will still be eligible to participate in the study Exclusion criteria
- A diagnosis of acute promyelocytic leukemia
- Patients with psychiatric or cognitive conditions which the treating oncologist believes prohibits informed consent or compliance with study procedures
- Prior cancer-directed treatment for AML
- Caregivers
- Selected by the patient when asked if there is a "family member, partner, friend or caregiver [age 18 or older] with whom you discuss or who can be helpful in healthrelated matters."
- Caregiver may be paid/professional or informal caregiver
- Able to provide informed consent
- English or Spanish-speaking
- Oncologists
- Oncologists caring for patients with AML Exclusion criteria
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
University of Alabama at Birmingham, Division of Hematology and Oncology
Birmingham, Alabama, 35233
Omer Jamy, 205-801-9034, omerjamy@uabmc.edu
- Recruiting
University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514
Daniel Richardson, 919-966-0127, daniel_richardson@med.unc.edu
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Kah Poh Loh, 585-276-4353, kahpoh_loh@urmc.rochester.edu
Becky Gravenstede, 585-727-4728, becky_gravenstede@urmc.rochester.edu
- Recruiting
Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Section of Hematology/Oncology
Winston-Salem, North Carolina, 27157
Heidi Klepin, 335-713-5440, hklepin@wakehealth.edu
About this study
This is a multicenter randomized controlled trial that assesses the efficacy of a decisional intervention [University of Rochester-Geriatric Oncology assessment for Acute myeloid Leukemia (UR-GOAL)] compared to an attention control.
Read the detailed description
This is a multicenter randomized controlled trial with four sites that assesses the efficacy of a decisional intervention [University of Rochester-Geriatric Oncology assessment for Acute myeloid Leukemia (UR-GOAL)] compared to an attention control. Subjects will be randomized 1:1 to either the intervention arm or the attention control arm. Compared to an attention control, UR-GOAL will improve patient distress, observed and patient-perceived shared decision making (SDM), and patient decisional conflict.
- Conditions
- Oncology, Myeloid Leukemia, Acute, Cancer
- Being tested
- UR-GOAL
- Keywords
- older adults, geriatric oncology, caregivers
- Medical subject headings
- Neoplasms, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UR-GOALBehavioural
Patients will view an AML video, complete the best/worst scaling, will be provided with a summary report, and will be asked to review and discuss at upcoming clinical visits. Caregivers, if available, will view an AML video, will be provided with a summary report, and will be asked to review. Oncologists will be provided with a summary report and will be asked to review and discuss at upcoming clinical visits.
| Study group | Role | What they receive |
|---|---|---|
| UR-GOAL Intervention | Experimental | Patients will view an AML video, complete the best-worst scaling, and be provided with a summary report consisting of their priorities; they will will be asked to review and discuss at upcoming clinical visits. Caregivers, if available, will view the same AML video and be provided with the same summary report. Oncologists will be provided with a summary report consisting of the patient's geriatric assessment, priorities, and perception of prognosis; they will be asked to review and discuss at upcoming clinical visits. Receives: Behavioral: UR-GOAL |
| Attention Control Arm | No intervention | Patients will view a nutritional video, complete a nutrition questionnaire, and will be provided with a nutrition handout and asked to review and discuss at upcoming clinical visits. Caregivers, if available, will view the nutritional video, and will be provided with a nutrition handout and asked to review and discuss at upcoming clinical visits. Oncologists will be provided with the patient's completed nutrition questionnaire and asked to review and discuss at upcoming clinical visits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distress Thermometer Questionnaire at 1 month
A self-report measure to capture distress and identify a list of sources of that distress. This is a 10-item scale, rated from 0-10 (0=no distress, 10=severe distress), with a possible total of 10; a higher score indicates greater distress.
Measured: 1 month
Secondary outcomes (3)
9-item Shared Decision Making Questionnaire at 2 weeks
9-item Shared Decision Making Questionnaire at 2 weeks
Measured: 2 weeks
Decisional Conflict Scale Questionnaire at 2 weeks
Decisional Conflict Scale Questionnaire at 2 weeks
Measured: 2 weeks
Observed shared decision making
OPTION5 instrument from audio-recorded treatment decision-making clinical visits
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start11 Jul 2025
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OncologyStudies 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
- Patients will be randomized 1:1 to either the UR-GOAL arm or the attention control arm. If the patient has a caregiver that agrees and consents to participate in the study, the caregiver will be enrolled onto the same arm as the patient.
- Masking
- None (open label)
- Enrolment
- 1,020 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kah Poh Loh, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697600
- Sponsor's protocol ID
- UOCPC24064
- Other IDs
- 1R01CA288318-01A1
- Acronym
- UR-GOAL RCT
- Status last verified
- Jul 2026
- First submitted
- 14 Nov 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
LoCastro M, Sanapala C, Wang Y, Jensen-Battaglia M, Wittink M, Norton S, Klepin HD, Richardson DR, Mendler JH, Liesveld J, Huselton E, O'Dwyer K, Cortes AM, Rodriguez C, Dale W, Loh KP. Patient-centered communication tool for older patients with acute myeloid leukemia, their caregivers, and oncologists: A single-arm pilot study. Cancer Med. 2023 Apr;12(7):8581-8593. doi: 10.1002/cam4.5547. Epub 2022 Dec 19.
PubMed 36533397
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Decisional Intervention for Older Adults With Acute Myeloid Leukemia and Their Caregivers
- ClinicalTrials.gov ID
- NCT06697600
- Acronym / sponsor ID
- UR-GOAL RCT / UOCPC24064
- Conditions
- Oncology, Myeloid Leukemia, Acute, Cancer
- Keywords
- older adults, geriatric oncology, caregivers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,020 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 20 Nov 2024 (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 multicenter randomized controlled trial that assesses the efficacy of a decisional intervention [University of Rochester-Geriatric Oncology assessment for Acute myeloid Leukemia (UR-GOAL)] compared to an attention control.
Detailed description
This is a multicenter randomized controlled trial with four sites that assesses the efficacy of a decisional intervention [University of Rochester-Geriatric Oncology assessment for Acute myeloid Leukemia (UR-GOAL)] compared to an attention control. Subjects will be randomized 1:1 to either the intervention arm or the attention control arm. Compared to an attention control, UR-GOAL will improve patient distress, observed and patient-perceived shared decision making (SDM), and patient decisional conflict.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized 1:1 to either the UR-GOAL arm or the attention control arm. If the patient has a caregiver that agrees and consents to participate in the study, the caregiver will be enrolled onto the same arm as the patient.
| Arm | Type | Receives |
|---|---|---|
| UR-GOAL Intervention | Experimental | Behavioral: UR-GOALPatients will view an AML video, complete the best-worst scaling, and be provided with a summary report consisting of their priorities; they will will be asked to review and discuss at upcoming clinical visits. Caregivers, if available, will view the same AML video and be provided with the same summary report. Oncologists will be provided with a summary report consisting of the patient's geriatric assessment, priorities, and perception of prognosis; they will be asked to review and discuss at upcoming clinical visits. |
| Attention Control Arm | No intervention | –Patients will view a nutritional video, complete a nutrition questionnaire, and will be provided with a nutrition handout and asked to review and discuss at upcoming clinical visits. Caregivers, if available, will view the nutritional video, and will be provided with a nutrition handout and asked to review and discuss at upcoming clinical visits. Oncologists will be provided with the patient's completed nutrition questionnaire and asked to review and discuss at upcoming clinical visits. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age ≥60 years (from date of consent, confirmed on electronic medical records)
- A new diagnosis of AML
- Cancer-directed treatment has not started
- The patient's oncologist has been or will be enrolled on the study
- English or Spanish-speaking
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-GOALPatients will view an AML video, complete the best/worst scaling, will be provided with a summary report, and will be asked to review and discuss at upcoming clinical visits. Caregivers, if available, will view an AML video, will be provided with a summary report, and will be asked to review. Oncologists will be provided with a summary report and will be asked to review and discuss at upcoming clinical visits. | Behavioural | UR-GOAL Intervention |
Primary outcome
Distress Thermometer Questionnaire at 1 month
Time frame: 1 month
A self-report measure to capture distress and identify a list of sources of that distress. This is a 10-item scale, rated from 0-10 (0=no distress, 10=severe distress), with a possible total of 10; a higher score indicates greater distress.
3 secondary outcomes
9-item Shared Decision Making Questionnaire at 2 weeks
Time frame: 2 weeks
Decisional Conflict Scale Questionnaire at 2 weeks
Time frame: 2 weeks
Observed shared decision making
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Background: PubMed 36533397LoCastro M, Sanapala C, Wang Y, Jensen-Battaglia M, Wittink M, Norton S, Klepin HD, Richardson DR, Mendler JH, Liesveld J, Huselton E, O'Dwyer K, Cortes AM, Rodriguez C, Dale W, Loh KP. Patient-centered communication tool for older patients with acute myeloid leukemia, their caregivers, and oncologists: A single-arm pilot study. Cancer Med. 2023 Apr;12(7):8581-8593. doi: 10.1002/cam4.5547. Epub 2022 Dec 19.
- 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.
4 sites 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 Oncology and Myeloid Leukemia, Acute, run by University of Rochester at 4 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 21 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kah Poh Loh (585-276-4353, Kahpoh_Loh@URMC.Rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distress Thermometer Questionnaire at 1 month (time frame: 1 month). 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 NCT06697600, which also lists 1 linked publication.
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 6 Jul 2026.