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Telehealth Advance Care Planning for Myeloid Leukemia (TeleSICP Trial)
N/A
Recruiting
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the study, up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will assess if a telehealth-delivered program helps older patients with blood cancers communicate better with healthcare providers, reduce anxiety/distress, & complete advance directives.
Who is the study for?
This trial is for individuals aged 60 or older with certain blood disorders, including acute myeloid leukemia and myelodysplastic syndrome. Participants must be receiving outpatient care, able to give informed consent, and speak English.
What is being tested?
The study is testing a telehealth program designed to improve healthcare communication and reduce patient anxiety. It also aims to increase the completion of advance directives like MOLST (medical orders for life-sustaining treatment) forms.
What are the potential side effects?
Since this trial involves an educational intervention rather than medication, traditional physical side effects are not expected. However, discussing serious illness may cause emotional discomfort.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout the study, up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study, up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Healthcare Communication: Health Care Climate Questionnaire
Secondary study objectives
Anxiety Symptoms: Generalized Anxiety Disorder-7 (GAD-7)
Completion of advance directives
Distress: Distress Thermometer
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Telehealth Serious Illness Care ProgramExperimental Treatment1 Intervention
The adapted telehealth Serious Illness Care Program is a multilevel intervention engaging the patient, caregiver, clinician, and system. It consists of tools, training, and system change. Tools include: 1) The Serious Illness Conversation Guide for clinicians; and 2) Education materials for patients on the importance of Serious Illness Conversations (Patient Preparation Pamphlet) and of the involvement of caregivers (Family Communication Guide).
Group II: ControlExperimental Treatment1 Intervention
Education materials developed by the NCI on "Communication in Cancer Care (PDQ®) - Patient Version"
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Who is running the clinical trial?
University of RochesterLead Sponsor
867 Previous Clinical Trials
548,675 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- N/AI am 60 years old or older.I am currently receiving treatment without staying in the hospital.I have been diagnosed with a type of blood cancer such as acute myeloid leukemia or myelodysplastic syndrome.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Telehealth Serious Illness Care Program
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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