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Psychological intervention for Acute Myeloid Leukemia
N/A
Waitlist Available
Led By Areej El-Jawahri, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Admitted to Massachusetts General Hospital for intensive induction chemotherapy requiring 4-6-week hospitalization
Adult patients (≥18 years)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing whether a psychological intervention app can help improve quality of life, mood, and symptoms in patients with acute myeloid leukemia.
Who is the study for?
This trial is for adults over 18 with a new diagnosis of acute myeloid leukemia (AML), who are hospitalized at Massachusetts General Hospital for intensive chemotherapy. Participants must speak English and be able to consent. Those with uncontrolled psychiatric disorders or cognitive impairments that affect study participation are excluded.Check my eligibility
What is being tested?
The study is testing the effectiveness of a mobile app designed to provide psychological support against usual care without the app. It aims to see if using the app improves quality of life, mood, and symptoms in patients undergoing treatment for AML.See study design
What are the potential side effects?
Since this trial involves a psychological intervention through an app, there may not be direct medical side effects like those from medication; however, users might experience emotional discomfort or distress as they engage with mental health content.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am admitted to Massachusetts General Hospital for a specific chemotherapy treatment.
Select...
I am 18 years old or older.
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I have been newly diagnosed with acute myeloid leukemia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility based on proportion of subjects enrolled and completing the app modules
Secondary outcome measures
Mood as measured by the Hospital Anxiety and Depression Scale (HADS)
Depressive Syndrome
Patient self-efficacy as measured by the Cancer Self-Efficacy Scale (CASE)
+2 moreSide effects data
From 2020 Phase 2 trial • 129 Patients • NCT032365066%
Injection site infection/abscess
4%
Illicit drug overdose
4%
Groin abcess
4%
Arthritis bacterial
2%
Nausea
2%
Streptococcus bacteraemia
2%
Renal colic
2%
Lower respiratory tract infection
2%
Abdominal pain
2%
Aspiration pneumonia
2%
Neck pain secondary to fall
2%
Loss of consciousness due to drug use
2%
Septic emboli
2%
Staphylococcal bacteraemia
2%
Vascular psuedoaneurysm
2%
Deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fortnightly Pick-up +Psych Intervention
Daily Observed Therapy
Fortnightly Pick-up
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Psychological appExperimental Treatment1 Intervention
Psychological intervention consist of four components
Supportive psychotherapy interventions to help patients deal with the initial shock of diagnosis, cope with the loss of independence and abrupt life disruptions, and provide validation and reassurance;
Psychoeducation to manage expectations and enhance preparedness for extended hospitalization and mobilize social supports;
Psychosocial skill-building to promote effective coping strategies and facilitate acceptance while living with uncertainty;
Self-care to promote positive health behaviors and enhance patients' sense of control especially as they transition from the hospital to outpatient care.
The psychological intervention will consist of four sessions (20-25 minutes each) that patients will start during their first week of admission for intensive chemotherapy and continue weekly
Group II: Usual CareActive Control1 Intervention
Participants receiving usual care will not have access to the psychological intervention app. -They will receive usual leukemia care with all the supportive care measures instituted by the leukemia team.
Patients in usual care will also meet with the leukemia social worker based on their request or at the discretion of the treating leukemia team
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Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,937 Previous Clinical Trials
13,198,990 Total Patients Enrolled
Areej El-Jawahri, MDPrincipal InvestigatorMassachusetts General Hospital
18 Previous Clinical Trials
4,452 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment still receiving new participants?
"Per the clinicaltrials.gov records, this medical study is not accepting patients at present. Initially posted on September 1st 2018 and last revised August 23rd 2022, it does not currently have any open recruitment slots; nonetheless, there are 1534 other trials that do need participants as of now."
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