Health TrialsbyHealthPanel

A Decisional Intervention for Older Adults With Acute Myeloid Leukemia and Their Caregivers

ConditionsOncologyMyeloid Leukemia, AcuteCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of Rochester

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

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."

Trial design

Design model

Parallel

Treatments tested in this trial

  • UR-GOAL

    Behavioral

    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.

Treatment groups

1,020 Participants
are divided into 2 treatment groups
Group A: UR-GOAL InterventionExperimental treatment 1 intervention
Group B: Attention Control ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
1 month

Secondary outcomes

1

9-item Shared Decision Making Questionnaire at 2 weeks

9-item Shared Decision Making Questionnaire at 2 weeks

Time frame
2 weeks
2

Decisional Conflict Scale Questionnaire at 2 weeks

Decisional Conflict Scale Questionnaire at 2 weeks

Time frame
2 weeks
3

Observed shared decision making

OPTION5 instrument from audio-recorded treatment decision-making clinical visits

Time frame
Day 0

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Rochester

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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