Acute Myeloid LeukemiaNCT03372291
Psychological Intervention Mobile App for Patients With AML
A study testing Psychological intervention in people with Acute Myeloid Leukemia, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
This research study is evaluating the impact of a psychological intervention mobile application (app) on the quality of life, mood, and symptoms of patients with acute myeloid leukemia (AML). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Psychological intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2018to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years).
- New diagnosis of acute myeloid leukemia.
- Admitted to Massachusetts General Hospital for intensive induction chemotherapy requiring 4-6-week hospitalization.
- The ability to provide informed consent.
- Ability to comprehend and speak English.
Who cannot join
- Significant uncontrolled psychiatric disorder (psychotic disorder, bipolar disorder,
- Major depression) or other co-morbid disease (dementia, cognitive impairment), which the treating clinician believes prohibits the ability to participate in study procedures
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02114
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Randomized Study of a Psychological Intervention Mobile Application (App) to Promote Coping in Patients With Acute Myeloid Leukemia (AML)
This research study is evaluating the impact of a psychological intervention mobile application (app) on the quality of life, mood, and symptoms of patients with acute myeloid leukemia (AML).
Read the detailed description
Patients with a new diagnosis of AML often confront a sudden and life-threatening diagnosis, requiring an immediate disruption of their life and an urgent 4-6 week hospitalization to initiate intensive chemotherapy. During this hospitalization, they endure substantial physical symptoms due to the side-effects of intensive chemotherapy, which negatively impacts their quality of life (QOL). Patients with AML also experience significant psychological distress as they struggle with the abrupt onset of illness, uncertainty regarding their prognosis, physical and social isolation during their hospitalization, and complete loss of independence. The study doctors want to know if the use of a mobile application (app) focused on helping patients cope with the diagnosis and treatment can reduce the distressing symptoms and improve the their quality of life and care.
The main purpose of this research study is see if a mobile app is feasible to use for patients with new diagnosis of AML and is acceptable to them. The study will also compare two types of care - standard leukemia care and standard leukemia care with the mobile app to see which is better for improving the experience of patients newly diagnosed with AML undergoing treatment.
The purpose of this research study is to find out whether using the mobile app that is focused on educating patients about leukemia and how to cope with its treatment can improve the physical and psychological symptoms that patients experience during hospitalization for their leukemia care. Using this research, the study doctors hope to find out the best way to help patients cope with their diagnosis and treatment for acute myeloid leukemia.
The study will use questionnaires to measure patient's quality of life, physical symptoms, mood, and the participant sense of control over their situation. Study questionnaires will be completed in the hospital or clinic with assistance provided as needed. The participants will also have the option of completing these questionnaires remotely through a secure web link or through a mailed paper copy
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Usual Care, Psychological intervention
- Keywords
- Acute Myeloid Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
Usual leukemia care with all the supportive care measures instituted by the leukemia team
Psychological interventionOther
Psychological intervention is focused on educating patients about leukemia and how to cope with its treatment
| Study group | Role | What they receive |
|---|---|---|
| Psychological app | Experimental | 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 Receives: Other: Psychological intervention |
| Usual Care | Active comparator | * 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 Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility based on proportion of subjects enrolled and completing the app modules
The intervention will be deemed feasible if at least 60% of eligible patients are enrolled in the study and for those enrolled, they must complete at least 60% of the intervention modules.
Measured: 2 years
Secondary outcomes (5)
Mood as measured by the Hospital Anxiety and Depression Scale (HADS)
Compare patient mood as measured by the Hospital Anxiety and Depression Scale (HADS) between the mobile app intervention and standard leukemia care. The HADS includes a depression and anxiety subscales (range 0 to 21) with higher scores indicating higher level of distress
Measured: up to day +40 after intensive chemotherapy
Patient depression syndrome as measured by the Patient-Health Questionnaire-9 (PHQ-9)
Compare patient depression symptoms as measured by the Patient Health Questionnaire (PHQ-9) between the mobile app intervention and standard leukemia care. The PHQ-9 has a score range of 0 to 27, with higher scores indicating worse depression symptoms.
Measured: up to day +40 after intensive chemotherapy
Quality of life as measured by the Functional Assessment of Cancer Therapy- Leukemia (FACT-Leuk)
Compare patient QOL as measured by the Functional Assessment of Cancer Therapy (FACT-Leukemia) between the mobile app intervention and standard leukemia care. The FACT-Leukemia score ranges from 0 to 176 with higher scores indicating better quality of life.
Measured: up to day +40 after intensive chemotherapy
Symptom burden as measured by the Edmonton Symptom Assessment Scale (ESAS)
Compare patient symptom burden as measured by the Edmonton Symptom Assessment Scale (ESAS) between the mobile app intervention and standard leukemia care. ESAS scores range from 0 to 100 with higher scores indicating worse symptom burden.
Measured: up to day +40 after intensive chemotherapy
Patient self-efficacy as measured by the Cancer Self-Efficacy Scale (CASE)
Compare patient self-efficacy as measured by CASE between the mobile app intervention and standard leukemia care. The CASE has a score range of 0 to 170 with higher scores indicating a better sense of self-efficacy
Measured: up to day +40 after intensive chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start1 Sep 2018
- Primary completion1 Jul 2021
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, El-Jawahri, Areej,M.D., Massachusetts General Hospital
- Investigators
- Areej El-Jawahri, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372291
- Sponsor's protocol ID
- 17-542
- Status last verified
- Aug 2024
- First submitted
- 9 Dec 2017
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jensen-Battaglia M, Sohn MB, Consagra W, Wang Y, Zhang Z, LoCastro M, Davis J, Buettner K, Mortaz S, El-Jawahri AR, Loh KP. Trajectories of physical well-being among adults with acute myeloid leukemia. Blood Adv. 2024 Jun 11;8(11):2612-2621. doi: 10.1182/bloodadvances.2023011804.
PubMed 38429079El-Jawahri A, Luskin MR, Greer JA, Traeger L, Lavoie M, Vaughn DM, Andrews S, Yang D, Boateng KY, Newcomb RA, Ufere NN, Fathi AT, Hobbs G, Brunner A, Abel GA, Stone RM, DeAngelo DJ, Wadleigh M, Temel JS. Psychological mobile app for patients with acute myeloid leukemia: A pilot randomized clinical trial. Cancer. 2023 Apr 1;129(7):1075-1084. doi: 10.1002/cncr.34645. Epub 2023 Jan 18.
PubMed 36655338
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of a Psychological Intervention Mobile Application (App) to Promote Coping in Patients With Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT03372291
- Acronym / sponsor ID
- 17-542
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 13 Dec 2017 (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 research study is evaluating the impact of a psychological intervention mobile application (app) on the quality of life, mood, and symptoms of patients with acute myeloid leukemia (AML).
Detailed description
Patients with a new diagnosis of AML often confront a sudden and life-threatening diagnosis, requiring an immediate disruption of their life and an urgent 4-6 week hospitalization to initiate intensive chemotherapy. During this hospitalization, they endure substantial physical symptoms due to the side-effects of intensive chemotherapy, which negatively impacts their quality of life (QOL). Patients with AML also experience significant psychological distress as they struggle with the abrupt onset of illness, uncertainty regarding their prognosis, physical and social isolation during their hospitalization, and complete loss of independence. The study doctors want to know if the use of a mobile application (app) focused on helping patients cope with the diagnosis and treatment can reduce the distressing symptoms and improve the their quality of life and care.
The main purpose of this research study is see if a mobile app is feasible to use for patients with new diagnosis of AML and is acceptable to them. The study will also compare two types of care - standard leukemia care and standard leukemia care with the mobile app to see which is better for improving the experience of patients newly diagnosed with AML undergoing treatment.
The purpose of this research study is to find out whether using the mobile app that is focused on educating patients about leukemia and how to cope with its treatment can improve the physical and psychological symptoms that patients experience during hospitalization for their leukemia care. Using this research, the study doctors hope to find out the best way to help patients cope with their diagnosis and treatment for acute myeloid leukemia.
The study will use questionnaires to measure patient's quality of life, physical symptoms, mood, and the participant sense of control over their situation. Study questionnaires will be completed in the hospital or clinic with assistance provided as needed. The participants will also have the option of completing these questionnaires remotely through a secure web link or through a mailed paper copy
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychological app | Experimental | Other: Psychological interventionPsychological 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 |
| Usual Care | Active comparator | Other: Usual Care* 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients (≥18 years).
- New diagnosis of acute myeloid leukemia.
- Admitted to Massachusetts General Hospital for intensive induction chemotherapy requiring 4-6-week hospitalization.
- The ability to provide informed consent.
- Ability to comprehend and speak English.
Key exclusion criteria (2 listed)
- Significant uncontrolled psychiatric disorder (psychotic disorder, bipolar disorder,
- Major depression) or other co-morbid disease (dementia, cognitive impairment), which the treating clinician believes prohibits the ability to participate in study procedures
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 |
|---|---|---|
| Usual CareUsual leukemia care with all the supportive care measures instituted by the leukemia team | Other | Usual Care |
| Psychological interventionPsychological intervention is focused on educating patients about leukemia and how to cope with its treatment | Other | Psychological app |
Primary outcome
Feasibility based on proportion of subjects enrolled and completing the app modules
Time frame: 2 years
The intervention will be deemed feasible if at least 60% of eligible patients are enrolled in the study and for those enrolled, they must complete at least 60% of the intervention modules.
5 secondary outcomes
Mood as measured by the Hospital Anxiety and Depression Scale (HADS)
Time frame: up to day +40 after intensive chemotherapy
Patient depression syndrome as measured by the Patient-Health Questionnaire-9 (PHQ-9)
Time frame: up to day +40 after intensive chemotherapy
Quality of life as measured by the Functional Assessment of Cancer Therapy- Leukemia (FACT-Leuk)
Time frame: up to day +40 after intensive chemotherapy
Symptom burden as measured by the Edmonton Symptom Assessment Scale (ESAS)
Time frame: up to day +40 after intensive chemotherapy
Patient self-efficacy as measured by the Cancer Self-Efficacy Scale (CASE)
Time frame: up to day +40 after intensive chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Derived from this study: PubMed 38429079Jensen-Battaglia M, Sohn MB, Consagra W, Wang Y, Zhang Z, LoCastro M, Davis J, Buettner K, Mortaz S, El-Jawahri AR, Loh KP. Trajectories of physical well-being among adults with acute myeloid leukemia. Blood Adv. 2024 Jun 11;8(11):2612-2621. doi: 10.1182/bloodadvances.2023011804.
- Derived from this study: PubMed 36655338El-Jawahri A, Luskin MR, Greer JA, Traeger L, Lavoie M, Vaughn DM, Andrews S, Yang D, Boateng KY, Newcomb RA, Ufere NN, Fathi AT, Hobbs G, Brunner A, Abel GA, Stone RM, DeAngelo DJ, Wadleigh M, Temel JS. Psychological mobile app for patients with acute myeloid leukemia: A pilot randomized clinical trial. Cancer. 2023 Apr 1;129(7):1075-1084. doi: 10.1002/cncr.34645. Epub 2023 Jan 18.
- 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. This study is not recruiting at the moment.
Areej El-Jawahri, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological intervention in people with Acute Myeloid Leukemia, run by Massachusetts General Hospital at 2 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility based on proportion of subjects enrolled and completing the app modules (time frame: 2 years). 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 NCT03372291, which also lists 2 linked publications.
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 13 Aug 2024.